A prospective, randomized, double-blind, placebo-controlled, multicentre, dose-finding clinical trial with polymerised mannan-conjugated allergoid Dactylis glomerata/Phleum pratense administered subcutaneously to patients with grass pollen-induced allergic rhinitis or rhinoconjunctivitis.

Start 1 Jun 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 26 sites · Protocol MG58-SIT-084

Overview

Sponsor-declared trial summary

Phase Phase II and Phase III (Integrated)

Status Ongoing, recruiting

Participants planned 450

Countries 1

Sites 26

Grass pollen induced allergic rhinitis or rhinoconjunctivitis

The primary objective of this trial is to assess the clinical efficacy of 2 concentrations (3000 mTU/mL, 9000 mTU/mL) EP-088_MG58 administered subcutaneously to participants with grass pollen-induced allergic rhinitis or rhinoconjunctivitis to determine the concentration with the best efficacy taking into account the s…

Key facts

Sponsor: Inmunotek S.L.
Participant type: Patients
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trial duration: 1 Jun 2026 → ongoing
Decision date (initial): 2026-05-29
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Conditions and MedDRA coding

Grass pollen induced allergic rhinitis or rhinoconjunctivitis

Version	Level	Code	Term	System organ class
20.0	LLT	10001728	Allergic rhinoconjunctivitis	10015919
20.0	LLT	10001726	Allergic rhinitis due to pollen	10021428

Study design 3 periods

#	Title	Allocation	Blinding	Roles blinded	Arms
1	Screening/pre-treatment observational phase Screening/pre-treatment observational phase to determine whether participants have a high enough CSMS to account for a moderate/severe grass pollen allergy.	Not Applicable	None
2	Treatment phase Treatment phase where the participants receive treatment.	Randomised Controlled	Double	[{"id":187053,"code":3,"name":"Monitor"},{"id":187052,"code":1,"name":"Subject"},{"id":187054,"code":2,"name":"Investigator"}]	Placebo: Participants who receive placebo control. EP-088_MG58 3000 mTU/mL: Participants who receive 3000 mTU/mL EP-088_MG58. EP-088_MG58 9000 mTU/mL: Participants who receive 9000 mTU/mL EP-088_MG58 .
3	Post-treatment observational phase Post-treatment observational phase to determine the effects of the treatment on the CSMS.	Randomised Controlled	Double	[{"id":187056,"code":1,"name":"Subject"},{"id":187057,"code":2,"name":"Investigator"},{"id":187058,"code":3,"name":"Monitor"}]	Placebo: Participants who receive placebo control. EP-088_MG58 3000 mTU/mL: Participants who receive 3000 mTU/mL EP-088_MG58. EP-088_MG58 9000 mTU/mL: Participants who receive 9000 mTU/mL EP-088_MG58 .

Regulatory references

Plan to share IPD: No

EU CT number	Title	Sponsor
2014-005471-88	Double blind, placebo-controlled, dose finding, prospective, multicenter clinical trial for the treatment of rhinitis/rinoconjuntivitis against grass pollen allergy, Ensayo clínico prospectivo multicéntrico aleatorizado de doble simulación controlado con placebo de búsqueda de la dosis más eficaz para el tratamiento de rinitis/rinoconjuntivitis por alergia frente al polen de Gramíneas

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

Participants aged from 18 to 64 years,
Signed and dated Informed Consent Form by a legally competent participant
Being in good physical and mental health
Having the diagnosis of moderate/severe grass pollen allergy based on all the following criteria: a. A medical history of moderate to severe allergic rhinitis or rhinoconjunctivitis due to grass pollen allergens for at least 2 previous seasons (definition of allergy severity according to ARIA), b. Being treated with anti-allergic medication for at least 2 grass pollen seasons prior to enrolment, c. A positive skin prick test (SPT - wheal diameter ≥3 mm) to grass pollen allergens, positive control (histamine) wheal ≥3 mm, negative control (NaCl) wheal <2 mm
Females with childbearing potential (a woman is considered of childbearing potential [WOCBP] according to the CTFG, if she is i.e., fertile, following menarche and until becoming postmenopausal unless becoming permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must a. Be willing to use a highly effective method of contraception: i. Oral, intravaginal or transdermal hormonal medical drugs or -devices containing oestrogen/progesterone combinations. ii. Oral, injectable or implantable hormonal medical drugs or -devices containing progesterone-only (if they prevent ovulation). iii. Intrauterine device (IUD). iv. Intrauterine hormone-releasing system (IUS). v. Bilateral tubal occlusion. vi. Vasectomized partner (provided, that partner is the sole sexual partner of the WOCB trial participant and that the vasectomized partner has received medical assessment of the surgical success). b. Have a negative pregnancy test in urine.
Females unable to bear children (i.e., pre-menarche, tubal ligation, hysterectomy, or post-menopausal (a postmenopausal state is defined as no menses for 12 months without an alternative medical cause.)
Confirmed diagnosis of controlled allergic (extrinsic) bronchial asthma within 4 weeks before the screening visit and during the entire trial according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2025)
For participants with obstructive or restrictive ventilation disorders (e.g. allergic [extrinsic] bronchial asthma, COPD, bronchial hyperreactivity): FEV1 ≥80% of the participant’s reference value or Peak Expiratory Flow (PEF) ≥80% of the participants´ individual optimal value
Moderate to severe allergic rhinitis/rhinoconjunctivitis confirmed by CSMS (any 14 days with the highest score out of 30 days of 1.3 – 5.5 [as calculated in a pre-planned analysis]) during the screening/pre-treatment observational phase (the results will be provided to the trial sites by the CRO).
Laboratory tests: a. Confirmed normal renal and liver function, including non-safety-related, non-clinically relevant (≤ grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials [FDA 2007]) deviations outside the reference ranges. Participants with deviations > grade 2 can be retested once or directly excluded. Upon normalisation (being ≤ grade 2, of the out-of-range value(s), non-clinically relevant) the participant will be eligible, b. Specific IgE against grass pollen allergens Phleum pratense (minimum CAP class 2 or higher, sIgE ≥0.7 kU/L), c. Negative pregnancy test in blood for female participants with childbearing potential (must be confirmed in urine at T1).

Exclusion criteria 34

Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion or participation in another investigational drug study with a washout period of less than 5 half-lives of the previous investigational medicinal product prior to the screening visit of the current study
Previous immunotherapy with grass pollen allergens within the last 5 years
Ongoing immunotherapy with grass pollen allergens or any other allergens
Participants with clinically relevant acute allergic rhinitis or rhinoconjunctivitis due to other environmental allergens during the observation period
Being in any relationship or dependence with the sponsor, CRO and/or Investigator,
Inability to understand instructions/trial documents,
Participants for whom the Investigator believes that they will not comply with the protocol (participants with known alcohol or drug abuse or with a history of a serious psychiatric disorder as well as participants unwilling to give informed consent or to abide by the requirements of the protocol)
Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
Participants who do not have access to a smartphone/tablet (iOS or Android, in exceptional cases, a paper diary may be issued if installation on the mobile device is not technically possible)
Participants with a sensitisation to other environmental allergens as determined by a positive SPT: a. Alternaria alternata (clinically or non-clinically significant) b. House dust mites, cat dander, dog dander (if clinically significant or existing exposure)
History of severe systemic reactions (grade III/IV) and/or anaphylaxis, including to food (e.g., peanut, marine animals) or to Hymenoptera venom (e.g., bee, wasp stings) or to medication (e.g., penicillin), etc.
History of hypersensitivity to the excipients of the investigational medicinal product, i.e., EP-088_MG58, or placebo
Participants with non-allergic (intrinsic) bronchial asthma
Mild persistent to severe persistent allergic (extrinsic) bronchial asthma, which is only partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2025) within 4 weeks before the screening visit and during the treatment period
Allergic (extrinsic) bronchial asthma, emphysema or other obstructive or restrictive ventilation disorders, particularly with a Forced Expiratory Volume in 1 second (FEV1) <80% of the participant’s reference value (ECSC) or Peak Expiratory Flow (PEF) <80% of the participant´s individual optimal value measured at the screening visit
Present clinical symptoms of upper or lower respiratory tract infection in the last two weeks before screening visit S1 or T1 visit and/or exacerbation of obstructive or restrictive ventilation disorders within 4 weeks before the screening visit S1 or T1 visit
Significant renal disease or chronic hepatic disease
Active malignant disease (ongoing or within the five past years)
Severe autoimmune disease
Immune defects including immunosuppression, immunopathies
Vaccination during the entire treatment period, except flu and SARS-CoV-2 vaccinations
Use of systemic immunosuppressive medications (e.g., systemic corticosteroids, methotrexate or cyclosporine A)
General inflammatory, severe acute or chronic inflammatory diseases
Other chronic diseases such as severe congestive heart failure, cardiovascular insufficiency, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.
Intake of antidepressant/antipsychotic drugs with potent antihistamine properties such as tricyclic and tetracyclic antidepressants or atypical neuroleptic drugs (e.g., doxepin, amitriptyline, desipramine, imipramine, mirtazapine, quetiapine, etc.)
Administration or planned administration of biologics (e.g., therapeutic antibodies), mast cell stabilizers or anti-leukotriene agents)
Intake of beta-blockers/ACE inhibitor medication (angiotensin-converting enzyme inhibitor)
Active tuberculosis
Having any contraindication for the use of adrenaline (including hyperthyroidism)
Known positive serology to Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus
Females who are pregnant, lactating, or of child-bearing potential and not using a highly effective contraceptive method
Administration of corticosteroids (systemic or nasal) or of anti-histaminic drugs within a defined time period preceding the trial (screening visit), as defined in the section Screening/Baseline Assessments and Procedures; exception made for routine control medication for asthmatic participants.
Compliance in diary entries being <14 days during the pre-treatment observation phase of 30 days).
Laboratory tests a. Participants with a sensitisation (CAP class 2 or higher, sIgE ≥0.7 kU/L) to Alternaria alternata (clinically or non-clinically significant), b. Clinically relevant laboratory values > grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) regarding renal/liver function at screening visit. Values can be retested once after at least 7 days. If the values remain out-of-range and (> grade 2) and clinically relevant, the participant must not be included.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Mean daily Combined Symptom and Medication Score (CSMS, as defined in the EAACI position paper by Pfaar et al., 2014) over the peak grass pollen season 2027.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Mannan-conjugated allergoid (polymerized) Phleum pratense and Dactylis glomerata parenteral vaccine

PRD11111246 · Product

Active substance: Phleum Pratense Pollen Enriched Allergoid, Mannan-Conjugated, Polymerised
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 9000 Other
Max total dose: 31000 Other
Max treatment duration: 35 Week(s)
Authorisation status: Not Authorised
ATC code: V01AA02 — GRASS POLLEN
MA holder: INMUNOTEK S.L.
Paediatric formulation: No
Orphan designation: No

Placebo 1

Placebo is identical in appearance an condition to the investigational medicinal product.

N/A · Product

Other product name: N/A
Pharmaceutical form: N/A
ATC code: N/A — N/A
Marketing authorisation: N/A
MA holder: N/A
MA country: Iceland
Paediatric formulation: No

Auxiliary 29

HAL Allergy Prick Test Katzenepithelien

PRD630688 · Product

Active substance: Cat Epithelia
Pharmaceutical form: SOLUTION FOR SKIN-PRICK TEST
Route of administration: SUBCUTANEOUS
Max daily dose: 0.02 ml millilitre(s)
Max total dose: 0.02 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: V01AA11 — ANIMALS
Marketing authorisation: 1437A/89N
MA holder: HAL ALLERGY B.V.
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

HAL Allergy Prick Test Gräserpollen-Mischung

PRD648013 · Product

Active substance: Phleum Pratense
Pharmaceutical form: SOLUTION FOR SKIN-PRICK TEST
Route of administration: SUBCUTANEOUS
Max daily dose: 0.02 ml millilitre(s)
Max total dose: 0.02 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: V04CL — TESTS FOR ALLERGIC DISEASES
Marketing authorisation: 760A/89N
MA holder: HAL ALLERGY B.V.
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

HAL Allergy Pricktest Negativkontrolle, Pricktestlösung

PRD6866428 · Product

Active substance: Phenol
Pharmaceutical form: SOLUTION FOR SKIN-PRICK TEST
Route of administration: SUBCUTANEOUS
Max daily dose: 0.02 ml millilitre(s)
Max total dose: 0.02 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: V04CL — TESTS FOR ALLERGIC DISEASES
Marketing authorisation: PEI.D.11973.01.1
MA holder: HAL ALLERGY B.V.
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

HAL Allergy Prick Test Alternaria alternata

PRD648102 · Product

Active substance: Alternaria Alternata
Pharmaceutical form: SOLUTION FOR SKIN-PRICK TEST
Route of administration: SUBCUTANEOUS
Max daily dose: 0.02 ml millilitre(s)
Max total dose: 0.02 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: V01AA04 — MOULD FUNGUS AND YEAST FUNGUS
Marketing authorisation: 1356A/89N
MA holder: HAL ALLERGY B.V.
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

HAL Allergy Pricktest 10 mg/ml Pricktestlösung zur Positivkontrolle

PRD943447 · Product

Active substance: Histamine Dihydrochloride
Pharmaceutical form: SOLUTION FOR SKIN-PRICK TEST
Route of administration: SUBCUTANEOUS
Max daily dose: 0.02 ml millilitre(s)
Max total dose: 0.02 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: V04CL — TESTS FOR ALLERGIC DISEASES
Marketing authorisation: 135136
MA holder: HAL ALLERGY B.V.
MA country: Austria
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

HAL Allergy Prick Test Hundeepithelien

PRD630687 · Product

Active substance: Dog Epithelia
Pharmaceutical form: SOLUTION FOR SKIN-PRICK TEST
Route of administration: SUBCUTANEOUS
Max daily dose: 0.02 ml millilitre(s)
Max total dose: 0.02 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: V04CL — TESTS FOR ALLERGIC DISEASES
Marketing authorisation: 1436A/89N
MA holder: HAL ALLERGY B.V.
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

HAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Pteronyssinus

PRD648010 · Product

Active substance: Dermatophagoides Pteronyssinus
Pharmaceutical form: SOLUTION FOR SKIN-PRICK TEST
Route of administration: SUBCUTANEOUS
Max daily dose: 0.02 ml millilitre(s)
Max total dose: 0.02 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: V01AA03 — HOUSE DUST
Marketing authorisation: 1403A/89N
MA holder: HAL ALLERGY B.V.
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

ALK Prick Negativ Kontrolle - Lösung für Haut-Pricktest

PRD2933129 · Product

Active substance: Water for Injection
Substance synonyms: Water for injections, WATER FOR INJECTABLE PREPARATIONS
Pharmaceutical form: SOLUTION FOR SKIN-PRICK TEST
Route of administration: SUBCUTANEOUS
Max daily dose: 0.02 ml millilitre(s)
Max total dose: 0.02 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: V04CL — TESTS FOR ALLERGIC DISEASES
Marketing authorisation: 1-26860
MA holder: ALK-ABELLO A/S
MA country: Austria
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

HAL Allergy Prick Test Wiesenlieschgras

PRD630663 · Product

Active substance: Phleum Pratense
Pharmaceutical form: SOLUTION FOR SKIN-PRICK TEST
Route of administration: SUBCUTANEOUS
Max daily dose: 0.02 ml millilitre(s)
Max total dose: 0.02 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: V01AA02 — GRASS POLLEN
Marketing authorisation: 753A/89N
MA holder: HAL ALLERGY B.V.
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

ALK Prick Positiv Kontrolle - Lösung für Haut-Pricktest

PRD916621 · Product

Active substance: Histamine Dihydrochloride
Substance synonyms: HISTAMINE HCL
Pharmaceutical form: SOLUTION FOR SKIN-PRICK TEST
Route of administration: SUBCUTANEOUS
Max daily dose: 0.02 ml millilitre(s)
Max total dose: 0.02 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: V04CL — TESTS FOR ALLERGIC DISEASES
Marketing authorisation: 1-26859
MA holder: ALK-ABELLO A/S
MA country: Austria
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Levocetirizin-ratiopharm 5 mg Filmtabletten

PRD819923 · Product

Active substance: Levocetirizine Dihydrochloride
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 5 mg milligram(s)
Max total dose: 140 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: R06AE09 — LEVOCETIRIZINE
Marketing authorisation: 71228.00.00
MA holder: RATIOPHARM GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension

PRD1878555 · Product

Active substance: Levocabastine Hydrochloride
Substance synonyms: (3S,4R)-1-[4-CYANO-4-(4-FLUOROPHENYL)CYCLOHEXYL]-3-METHYL-4-PHENYLPIPERIDINE-4-CARBOXYLIC ACID HYDROCHLORIDE
Pharmaceutical form: EYE DROPS, SUSPENSION
Route of administration: OPHTHALMIC USE
Max daily dose: 0.06 mg milligram(s)
Max total dose: 1.68 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: S01GX02 — LEVOCABASTINE
Marketing authorisation: 21735.00.00
MA holder: KENVUE GERMANY GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Desloratadin Glenmark 5 mg Tabletten

PRD442247 · Product

Active substance: Desloratadine
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 5 mg milligram(s)
Max total dose: 140 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: R06AX27 — DESLORATADINE
Marketing authorisation: 84037.00.00
MA holder: GLENMARK ARZNEIMITTEL GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung

PRD7928190 · Product

Active substance: Olopatadine
Pharmaceutical form: EYE DROPS, SOLUTION
Route of administration: OPHTHALMIC USE
Max daily dose: 0.2 mg milligram(s)
Max total dose: 5.6 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: S01GX09 — OLOPATADINE
Marketing authorisation: 139405
MA holder: MICRO LABS GMBH
MA country: Austria
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Alvesco 160 Mikrogramm Druckgasinhalation, Lösung

PRD8261232 · Product

Active substance: Ciclesonide
Substance synonyms: BI54903
Pharmaceutical form: PRESSURISED INHALATION, SOLUTION
Route of administration: INHALATION
Max daily dose: 160 µg microgram(s)
Max total dose: 4480 µg microgram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: R03BA08 — -
Marketing authorisation: 60978.02.00
MA holder: COVIS PHARMA EUROPE B.V.
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Fexofenadin Winthrop 180 mg Filmtabletten

PRD6671460 · Product

Active substance: Fexofenadine Hydrochloride
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 180 mg milligram(s)
Max total dose: 5040 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: R06AX26 — FEXOFENADINE
Marketing authorisation: 76707.00.00
MA holder: WINTHROP ARZNEIMITTEL GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rupatadin AL 10 mg Tabletten

PRD3786477 · Product

Active substance: Rupatadine
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 280 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: R06AX28 — RUPATADINE
Marketing authorisation: 95784.00.00
MA holder: ALIUD PHARMA GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

AVAMYS 27.5 micrograms/spray, nasal spray suspension

PRD2139571 · Product

Active substance: Fluticasone Furoate
Substance synonyms: GW685698
Pharmaceutical form: NASAL SPRAY, SUSPENSION
Route of administration: NASAL SPRAY
Max daily dose: 110 µg microgram(s)
Max total dose: 3080 µg microgram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: R01AD12 — -
Marketing authorisation: EU/1/07/434/001
MA holder: GLAXOSMITHKLINE TRADING SERVICES LIMITED
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bilaxten 6 mg/ml Augentropfen, Lösung

PRD10565596 · Product

Active substance: Bilastine
Pharmaceutical form: EYE DROPS, SOLUTION
Route of administration: OPHTHALMIC USE
Max daily dose: 0.2 µg microgram(s)
Max total dose: 5.6 µg microgram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: S01GX13 — -
Marketing authorisation: 7003340.00.00
MA holder: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

EMADINE 0.5 mg/ml, eye drops, solution

PRD9138446 · Product

Active substance: Emedastine
Pharmaceutical form: EYE DROPS, SOLUTION
Route of administration: OPHTHALMIC USE
Max daily dose: 0.1 mg milligram(s)
Max total dose: 2.8 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: S01GX06 — EMEDASTINE
Marketing authorisation: EU/1/98/095/001
MA holder: IMMEDICA PHARMA AB
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Loratadin-ratiopharm® 10 mg Tabletten

PRD575476 · Product

Active substance: Loratadine
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 280 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: R06AX13 — LORATADINE
Marketing authorisation: 49363.00.00
MA holder: RATIOPHARM GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension

PRD2103953 · Product

Active substance: Fluticasone Propionate
Pharmaceutical form: NASAL SPRAY, SUSPENSION
Route of administration: NASAL SPRAY
Max daily dose: 160 µg microgram(s)
Max total dose: 4480 µg microgram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: R01AD08 — FLUTICASONE
Marketing authorisation: 66605.00.00
MA holder: TEVA GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Azelastin COMOD 0,5 mg/ml Augentropfen

PRD2071026 · Product

Active substance: Azelastine Hydrochloride
Substance synonyms: AZELASTINE MONOHYDROCHLORIDE
Pharmaceutical form: EYE DROPS, SOLUTION
Route of administration: OPHTHALMIC USE
Max daily dose: 0.06 mg milligram(s)
Max total dose: 1.68 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: S01GX07 — AZELASTINE
Marketing authorisation: 1-31587
MA holder: URSAPHARM GES.M.B.H.
MA country: Austria
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension

PRD481566 · Product

Active substance: Triamcinolone Acetonide
Pharmaceutical form: NASAL SPRAY, SUSPENSION
Route of administration: NASAL SPRAY
Max daily dose: 220 µg microgram(s)
Max total dose: 6160 µg microgram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: R01AD11 — TRIAMCINOLONE
Marketing authorisation: 41503.00.00
MA holder: A. NATTERMANN & CIE. GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cetirizin-ratiopharm® bei Allergien Filmtabletten

PRD599241 · Product

Active substance: Cetirizine Dihydrochloride
Substance synonyms: CETIRIZINE HYDROCHLORIDE
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 280 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: R06AE07 — CETIRIZINE
Marketing authorisation: 47299.00.00
MA holder: RATIOPHARM GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension

PRD2205394 · Product

Active substance: Mometasone Furoate
Pharmaceutical form: NASAL SPRAY, SUSPENSION
Route of administration: NASAL SPRAY
Max daily dose: 200 µg microgram(s)
Max total dose: 5600 µg microgram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: R01AD09 — MOMETASONE
Marketing authorisation: 135175
MA holder: TEVA B.V
MA country: Austria
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ebastin Aristo 10 mg Filmtabletten

PRD570814 · Product

Active substance: Ebastine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 20 mg milligram(s)
Max total dose: 560 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: R06AX22 — EBASTINE
Marketing authorisation: 73718.00.00
MA holder: ARISTO PHARMA GMBH (ART 57)
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Allegra Allergietabletten 20 mg Tabletten

PRD10085089 · Product

Active substance: Bilastine
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 20 mg milligram(s)
Max total dose: 560 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: R06AX29 — -
Marketing authorisation: 7004523.00.00
MA holder: A. NATTERMANN & CIE. GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

PRD749140 · Product

Active substance: Budesonide
Pharmaceutical form: NASAL SPRAY, SUSPENSION
Route of administration: NASAL SPRAY
Max daily dose: 256 µg microgram(s)
Max total dose: 7168 µg microgram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: R01AD05 — BUDESONIDE
Marketing authorisation: 67867.00.00
MA holder: HEXAL AG
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Inmunotek S.L.

Sponsor organisation: Inmunotek S.L.
Address: Calle Punto Mobi 5
City: Alcala De Henares
Postcode: 28805
Country: Spain

Scientific contact point

Organisation: Inmunotek S.L.
Contact name: Miguel Casanovas

Public contact point

Organisation: Inmunotek S.L.
Contact name: Miguel Casanovas

Third parties 3

Organisation	City, country	Duties
Medicoline Pharma Solutions KG ORG-100026768	Steinbach (Taunus), Germany	Other
ClinCompetence Cologne GmbH ORG-100049151	Cologne, Germany	On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 2, Code 5, Data management, E-data capture, Code 8
Mlm Medical Labs GmbH ORG-100043721	Moenchengladbach, Germany	Laboratory analysis

Locations

1 EU/EEA country · 26 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Ongoing, recruiting	450	26
Rest of world	—	0	—

Investigational sites

Germany

26 sites · Ongoing, recruiting

Klinikum Stuttgart, Klinik fur Dermatologie and Allergologie, Allergieabteilung, Ambulanz 3

Zentrum für Dermatologie, Phlebologie und Allergologie, Priessnitzweg 24, 70374, Stuttgart

Praxis Dr. Jörg Winkler Pneumologisches Studienzentrum

Studienzentrum, Goldschmidtstrasse 30, 04103, Leipzig

HNO Praxis Dr. Thieme

Studienzentrum, Mercatorstraße 10-12, 47051, Duisburg

Praxis für HNO und Allergologie

Studienzentrum, Overbeckstr 33, 01139, Dresden

Studienzentrum Dr. Christian Schlenska

Studienzentrum, Duttenstedter Strasse 13a, 1. OG, Peine

Medaimun GmbH

Studienzentrum, Kennedyallee 97a, Sachsenhausen, Frankfurt Am Main

HNO Praxis Dreieich

Studienzentrum, Heckenweg 3, 63303, Dreieich

HNO research GmbH

Studienzentrum, Sandkuhle 17, 25524, Itzehoe

Klinische Forschung Osnabrueck

KliFOs - Klinische Forschung Osnabrück, Hakenstrasse 1, Innenstadt, Osnabrueck

ENT-Research GmbH

Studienzentrum, Bocholder Str. 2, 45355, Essen

Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH

Studienzentrum, Robert-Koch-Strasse 1, 63263, Neu-Isenburg

Studienzentrum MOL

Studienzentrum, Rosa-Luxemburg-Damm 1, 15366, Neuenhagen

Pneumologische Praxis München-Pasing

Studienzentrum, Gleichmannstr. 5, 81241, München

Hautzentrum Friedrichshain

Studienzentrum, Frankfurter Allee 100, 10247, Berlin

Praxisgemeinschaft Reiber & Partner

Studienzentrum, Welzheimer Straße 15, 73614, Schorndorf

CentroDerm GmbH

Studienzentrum, Heinz-Fangman-Strasse 57, Barmen, Wuppertal

Universitätsklinikum Carl Gustav Carus, Klinik für HNO-Heilkunde/Allergologie

HNO Studienabteilung, Fetscherstr. 74, 01307, Dresden

MVZ Dr. Kasche und Kollegen GmbH

Studienzentrum, Langelohstraße 158, 22549, Hamburg

Studienzentrum Dr. Sabine Lassmann

Studienzentrum, Obere Strasse 18-20, 07318, Saalfeld

Medizentrum Essen Borbeck

Studienzentrum, Huelsmannstrasse 6, Borbeck, Essen

Berufsausuebungsgemeinschaft Bag Prof. Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR

Studienzentrum, Holzhaeuser Strasse 78a, Stoetteritz, Leipzig

Universitätsklinikum Marburg, Abtlg. f. HNO-Heilkunde, Kopf- Halschirurgie, Sektion Rhinolog

Sektion Rhinologie und Allergologie, Baldingerstraße, 35043, Marburg

GEKA Gesellschaft fuer Experimentelle und Klinische Atemwegsforschung mbH

Studienzentrum, Berta Cramer Ring 30, 65205, Wiesbaden

HNO Praxis Dresden Dr. med. Udo Schäfer

Studienzentrum, Altmarkt 10A, 01067, Dresden

Praxis Dr. Thomas Ginko

Allergie- und Asthma Studienzentrum, Karl Carstens Str 10, 53113, Bonn

Praxis Dr. Virgil-Oreste Mihaescu

Studienzentrum, Froelichstrasse 8, 86150, Augsburg

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Germany	2026-06-01		2026-06-01

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol_2025-524580-21-00_redacted	1.3
Protocol (for publication)	D1_Protocol_Annex_V1-0_2025-524580-21-00	1.0
Protocol (for publication)	D4_Diary_after_treatment_gp-season_2027_redacted	1.0
Protocol (for publication)	D4_Diary_screeningphase_gp-season__2026_redacted	1.0
Protocol (for publication)	D4_Diary_treatment diary_redacted	1.0
Protocol (for publication)	D4_Questionnaire_RQLQ_redacted	1
Recruitment arrangements (for publication)	K1_recruitment_arrangements	1.0
Recruitment arrangements (for publication)	K2_Recruitment material advertisment print	1.0
Recruitment arrangements (for publication)	K2_Recruitment material advertisment web	1.0
Recruitment arrangements (for publication)	K2_Recruitment material advertisment_site_Pauser	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_participants_redacted	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_pregnancy_partner_redacted	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_pregnancy_redacted	1.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Dataprotection_STUDYDiary_redacted	1.0
Subject information and informed consent form (for publication)	L2_Other subject information material_insurance policy	1
Subject information and informed consent form (for publication)	L2_Other subject information material_Participant card_redacted	1.0
Subject information and informed consent form (for publication)	L2_User_Manual_STUDYDiary	1.0
Summary of Product Characteristics (SmPC) (for publication)	Not applicable SmPc	1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2026-02-19	Germany	Acceptable 2026-05-26	2026-05-29