Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ended
Participants planned
512
Countries
1
Sites
2
Moderate-to-severe allergic rhinitis / rhinoconjunctivitis due to grass pollen for at least two years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline
The purpose of this trial is to establish the most effective and best tolerated dose of SULGEN® Spray Phleum pratense in terms of benefit-risk balance and CSMS (Combined Symptom and Medication Score).
Key facts
- Sponsor
- ROXALL Medizin GmbH, ROXALL Medizin GmbH
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 10 Nov 2023 → 3 Jan 2025
- Decision date (initial)
- 2023-09-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Roxall Medizin GmbH
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Dose response, Therapy, Efficacy
The purpose of this trial is to establish the most effective and best tolerated dose of SULGEN®
Spray Phleum pratense in terms of benefit-risk balance and CSMS (Combined Symptom and
Medication Score).
Conditions and MedDRA coding
Moderate-to-severe allergic rhinitis / rhinoconjunctivitis due to grass pollen for at least two years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-000966-PIP01-10
| EU CT number | Title | Sponsor |
|---|---|---|
| 2021-002881-42 | Phase II study to assess the tolerability, safety and efficacy of sublingual immunotherapy in patients suffering from grass pollen allergy |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Patients who signed and dated the informed consent form obtained prior to any study specific examination
- Female or male patients between 18 and 65 years of age at the time of signing the informed consent form
- Patients with moderate-to-severe allergic rhinitis / rhinoconjunctivitis due to grass pollen for at least two years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline, either with well-controlled mild-to-moderate asthma defined in GINA guideline (Global Initiative for Asthma, 2022) or without asthma
- Forced expiratory volume (FEV1) in one second > 70 % of predicted normal value (only for asthmatic patients)
- Sensitization to Phleum pratense pollen, verified by: 1. positive skin prick test (wheal diameter ≥ 3 mm and negative control < 2 mm and positive (histamine) control ≥ 3 mm) and 2. serum allergen-specific IgE to Phleum pratense ≥ 0.7 kU/L (CAP EAST class ≥ 2) and 3. a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) ≥ 2 (0-3 scale) based on the most severe days during one of the two GPS preceding enrolment and 4. positive response to nasal provocation with Phleum pratense pollen allergen extract (at least at the third concentration step)
- Assumed compliance and ability of the patient to understand the patient´s electronic diary and to follow the instructions of the study staff
- Compliance and ability of the patient to complete an electronic diary for self-evaluation of the symptoms and rescue medication
- Safety laboratory results within the normal range or considered to be not clinically significant in any other case
Exclusion criteria 32
- Previous immunotherapy with grass pollen allergen extracts according to the homologous group of grass pollen of the "Poaceae group", as defined in Annex 1 in the Guideline on allergen products: production and quality issues (EMEA/CHMP/BWP/304831), within the last 5 years
- Patients with co-sensitizations or co-allergies to any perennial or seasonal allergen (with exception of any other Poaceae), which interfere with the conduct of the study (e. g. with the tNPT), especially if the result in SPT for this allergen is higher than that for Phleum pratense
- Patients with co-sensitizations to any mould or pollen with overlapping season but which are not cross-reactive with Phleum pratense and with specific IgE levels ≥ class 2 CAP/PHADIA (unless the relevance can be excluded by component resolved diagnosis)
- Simultaneous participation in other clinical trials
- Simultaneous specific immunotherapy with other allergens
- Participation in a clinical trial in the last three months before enrolment
- Contraindications for SLIT (Pitsios et al., 2015)
- Contraindications for SPT
- Contraindications for NPT
- Serious systemic reactions to allergen-specific immunotherapy in the past
- Hypersensitivity to excipients of the IMP
- Any severe or unstable lung disease e. g. active tuberculosis, cystic fibrosis, COPD
- Severe, or partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative for Asthma, 2022)
- Asthmatic patients with FEV1 ≤ 70 % of predicted normal value at screening
- Chronic or severe acute diseases of nose or eyes
- Irreversible secondary disorders of the target organs (e. g. emphysema, bronchiectasis)
- Therapy with immunoglobulins
- Completed or ongoing treatment with an anti-IgE-antibody (like Omalizumab) and/or checkpoint-inhibitor
- Diseases of the immune system including autoimmune and immune deficiencies (with exception to well-controlled Hashimoto thyroiditis and type-1 diabetes mellitus)
- Severe acute or chronic inflammatory or infectious diseases
- Chronic or acute diseases of the heart, kidney or liver with severe impairment of their function
- Malignancy within the previous 5 years
- Active chronic urticaria
- Active severe atopic eczema
- Alcohol, drug, or medication abuse within the past year and/or during the study
- Existing or intended pregnancy, lactation or inadequate contraceptive measures for woman with childbearing potential or a positive pregnancy test at screening
- Use of non-allowed medication
- Severe psychiatric, psychological, or neurological disorders; completed or ongoing longterm treatment with tranquilizer or psychoactive drugs (including tricyclic anti-depressants)
- Relationship or dependence with the sponsor and/or investigator
- Legal incapacity
- Patients who are jurisdictional or governmentally institutionalized
- Risk of non-compliance by the patient with the study procedures
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary (efficacy) endpoint is defined as the absolute differences in mean CSMS (Combined Symptom and Medication Score) during Peak Grass Pollen Period (PGPP) of each active treatment group compared to placebo treatment group.
Secondary endpoints 8
- Absolute and relative differences in mean CSMS during Grass Pollen Season (GPS) between active and placebo treatment groups.
- Absolute and relative differences in mean dSS during PGPP and GPS
- Absolute and relative differences in mean dMS during PGPP and GPS
- Global Rhinoconjunctivitis Discomfort with a Visual Analogue Scale (VAS)
- Change in Rhinoconjunctivitis quality of life questionnaire (RQLQ) between active and placebo treatment groups comparing basal and post-treatment scoring
- Well and severe days: A well day is defined as a day without administration of any rescue medication (dMS = 0) and with dSS < 0.34 (range 0-3). A severe day is defined (acc. to Pfaar et al. 2014a) as a day with a single score = 3 in any of the six symptoms. Percentages of well and severe days will be calculated for each subject as the number of well or severe days in the PGPP and GPS in relation to the number of days comprising both periods
- Symptom-free days are defined as the days with absence of symptoms (dSS = 0) and without administration of any rescue medication (dMS = 0), expressed as percentage of days during the PGPP and GPS
- tNPT titrated Nasal Provocation Test: To assess the efficacy of each dose of SULGEN® Spray Phleum pratense compared to placebo. Defined as percentage of patients with an increased dosing step and the change in number of dosing steps needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the four treatment groups. This is based on the change of the response to nasal provocation (tNPT) with
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
SULGEN® Spray Phleum pratense high dose
PRD10389402 · Product
- Active substance
- Phleum Pratense Pollen Extract
- Pharmaceutical form
- SUBLINGUAL SPRAY, SOLUTION
- Route of administration
- SUBLINGUAL USE
- Max daily dose
- 0.2 ml millilitre(s)
- Max total dose
- 68 ml millilitre(s)
- Max treatment duration
- 340 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- V01AA02 — GRASS POLLEN
- MA holder
- ROXALL MEDIZIN GMBH
- Paediatric formulation
- No
- Orphan designation
- No
SULGEN® Spray Phleum pratense mid dose
PRD10389401 · Product
- Active substance
- Phleum Pratense Pollen Extract
- Pharmaceutical form
- SUBLINGUAL SPRAY, SOLUTION
- Route of administration
- SUBLINGUAL USE
- Max daily dose
- 0.2 ml millilitre(s)
- Max total dose
- 68 ml millilitre(s)
- Max treatment duration
- 340 Day(s)
- Authorisation status
- Not Authorised
- ATC code
- V01AA02 — GRASS POLLEN
- MA holder
- ROXALL MEDIZIN GMBH
- Paediatric formulation
- No
- Orphan designation
- No
SULGEN® Spray Phleum pratense low dose
PRD10389400 · Product
- Active substance
- Phleum Pratense Pollen Extract
- Pharmaceutical form
- SUBLINGUAL SPRAY, SOLUTION
- Route of administration
- SUBLINGUAL USE
- Max daily dose
- 0.2 ml millilitre(s)
- Max total dose
- 68 ml millilitre(s)
- Max treatment duration
- 340 Day(s)
- Authorisation status
- Not Authorised
- ATC code
- V01AA02 — GRASS POLLEN
- MA holder
- ROXALL MEDIZIN GMBH
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
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 23
ALK-prick SQ 553 Hundehaare 10 HEP Lösung für den Pricktest
PRD925145 · Product
- Active substance
- Canis Familiaris (553)
- Substance synonyms
- 553 dog hair
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- 208A/85A
- MA holder
- ALK-ABELLÓ ARZNEIMITTEL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRICK TEST Alternaria alternata LETI, 30 HEP/ml Pricktestlösung.
PRD625123 · Product
- Active substance
- Alternaria Alternata Extract
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- PEI.D.02949.02.1
- MA holder
- LETI PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD783669 · Product
- Active substance
- Loratadine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 3400 mg milligram(s)
- Max treatment duration
- 340 Day(s)
- Authorisation status
- Authorised
- ATC code
- R06AX13 — LORATADINE
- Marketing authorisation
- 47097.00.00
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Prick Test Histamin LETI Positivkontrolle 10 mg/ml Pricktestlösung
PRD8299459 · Product
- Active substance
- Histamine Dihydrochloride
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- 99219.00.00
- MA holder
- LETI PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALK-prick N - 402 Alternaria alternata (tenuis) - 1:20 G/V - Lösung für den Pricktest
PRD924755 · Product
- Active substance
- Alternaria Alternata (402)
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- 224A/85
- MA holder
- ALK-ABELLÓ ARZNEIMITTEL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALK-prick Positiv-Kontrolle ist ein Histaminpräparat für die Pricktestung.
PRD935435 · Product
- Active substance
- Histamine Dihydrochloride
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- 40429.00.00
- MA holder
- ALK-ABELLÓ ARZNEIMITTEL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALK-prick SQ - 312 Beifuß - 10 HEP - Lösung für den Pricktest
PRD925136 · Product
- Active substance
- Artemisia Vulgaris (312)
- Substance synonyms
- 312 Mugwort
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- 152A/85A
- MA holder
- ALK-ABELLÓ ARZNEIMITTEL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRICK TEST Beifuss LETI, 30 HEP/ml Pricktestlösung.
PRD625124 · Product
- Active substance
- Artemisia Vulgaris Pollen Extract
- Substance synonyms
- MUGWORT POLLEN EXTRACT
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- PEI.D.02488.01.1
- MA holder
- LETI PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRICK TEST Lieschgras LETI, 30 HEP/ml Pricktestlösung
PRD625152 · Product
- Active substance
- Timothy Grass Pollen Extract
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- PEI.D.01554.02.1
- MA holder
- LETI PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALK-prick SQ - 108 Birke - 10 HEP - Lösung für den Pricktest
PRD925131 · Product
- Active substance
- Betula Verrucosa (108)
- Substance synonyms
- BETULA VERRUCOSA (PENDULA) (108), 108 BETULA VERRUCOSA
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- 141A/85A
- MA holder
- ALK-ABELLÓ ARZNEIMITTEL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD625175 · Product
- Active substance
- Timothy Grass Pollen Extract
- Pharmaceutical form
- SOLUTION FOR PROVOCATION TEST
- Route of administration
- NASAL USE
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 1.6 ml millilitre(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- PEI.D.01554.02.2
- MA holder
- LETI PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Prednisolon AL 10 mg Tabletten
PRD1964516 · Product
- Active substance
- Prednisolone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 3.4 g gram(s)
- Max treatment duration
- 340 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- 59532.01.00
- MA holder
- ALIUD PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALK-prick SQ - 225 Wiesenlieschgras - 10 HEP - Lösung für den Pricktest
PRD925130 · Product
- Active substance
- Phleum Pratense (225)
- Substance synonyms
- 225 PHLEUM PRATENSE, 225 Timothy Grass
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- 148A/85A
- MA holder
- ALK-ABELLÓ ARZNEIMITTEL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Prick Test LETI Negativkontrolle Pricktestlösung
PRD8299604 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID, SODIUM CHLORIDE (FOR PH ADJUSTMENT)
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- 99220.00.00
- MA holder
- LETI PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALK-prick SQ - 503 Milbe Dermatophagoides pteronyssinus, 10 HEP, Lösung für den Pricktest
PRD925149 · Product
- Active substance
- Dermatophagoides Pteronyssinus (503)
- Substance synonyms
- 503 House Dust Mite Dermatophagoides pteronyssinus
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- 220A/85A
- MA holder
- ALK-ABELLÓ ARZNEIMITTEL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD917461 · Product
- Active substance
- Mometasone Furoate
- Pharmaceutical form
- NASAL SPRAY, SUSPENSION
- Route of administration
- NASAL SPRAY
- Max daily dose
- 0.1 mg milligram(s)
- Max total dose
- 34.0 mg milligram(s)
- Max treatment duration
- 340 Day(s)
- Authorisation status
- Authorised
- ATC code
- R01AD09 — MOMETASONE
- Marketing authorisation
- 82290.00.00
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALK-prick SQ - 555 Katzenhaare - 10 HEP - Lösung für den Pricktest
PRD925143 · Product
- Active substance
- Felis Domesticus (555)
- Substance synonyms
- 555 Cat Hair
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- 209A/85A
- MA holder
- ALK-ABELLÓ ARZNEIMITTEL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRICK TEST Birkenpollen LETI, 30 HEP/ml Pricktestlösung.
PRD625125 · Product
- Active substance
- Betula Alba Pollen Extract
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- PEI.D.02356.01.1
- MA holder
- LETI PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALK-prick Negativ-Kontrolle Pricktestlösung
PRD2933517 · Product
- Active substance
- Histamine Dihydrochloride
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- 88638.00.00
- MA holder
- ALK-ABELLO A/S
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRICK TEST Hundeepithel LETI, 30 HEP/ml Pricktestlösung.
PRD625135 · Product
- Active substance
- Dog Epithelium Extract
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- PEI.D.02965.01.1
- MA holder
- LETI PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRICK TEST Dermatophagoides pteronys- sinus LETI, 100 HEP/ml Pricktestlösung.
PRD625122 · Product
- Active substance
- Dermatophagoides Pteronyssinus Extract
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- PEI.D.01598.01.1
- MA holder
- LETI PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRICK TEST Katzenepithel LETI, 30 HEP/ml Pricktestlösung.
PRD625139 · Product
- Active substance
- Cat Epithelium Extract
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- PEI.D.02762.01.1
- MA holder
- LETI PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALK-prick N - 302 Ragweed (Ambrosia) - 1:100 G/V - Lösung für den Pricktest
PRD924686 · Product
- Active substance
- Ambrosia Artemisiifolia (302)
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- TOPICAL
- Max daily dose
- 1 Gtt drop(s)
- Max total dose
- 1 Gtt drop(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- 187A/85A
- MA holder
- ALK-ABELLÓ ARZNEIMITTEL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
ROXALL Medizin GmbH
- Sponsor organisation
- ROXALL Medizin GmbH
- Address
- Carl-Petersen-Strasse 4, Hamm-Nord Hamm-Nord
- City
- Hamburg
- Postcode
- 20535
- Country
- Germany
Scientific contact point
- Organisation
- ROXALL Medizin GmbH
- Contact name
- Dr. Elshan Aghayev
Public contact point
- Organisation
- ROXALL Medizin GmbH
- Contact name
- Dr. Elshan Aghayev
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| ICRC-Weyer GmbH ORL-000002080
|
Berlin, Germany | Code 10 |
ROXALL Medizin GmbH
- Sponsor organisation
- ROXALL Medizin GmbH
- Address
- Carl-Petersen-Strasse 4, Hamm-Nord Hamm-Nord
- City
- Hamburg
- Postcode
- 20535
- Country
- Germany
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 30 | 2 |
| Rest of world
Ukraine, Turkey
|
— | 482 | — |
Investigational sites
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 | 2023-11-10 | 2024-11-07 | 2023-12-01 | 2023-12-05 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-17 | Germany | Acceptable 2023-09-22
|
2023-09-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-11-08 | Germany | Acceptable 2023-09-22
|
2023-11-08 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-11-15 | Germany | Acceptable 2023-09-22
|
2023-11-15 |