Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
184
Countries
5
Sites
27
Chronic Rhinosinusitis (CRS) in Adults
The primary objective is to evaluate the efficacy of LYR-210, compared with a sham procedure control, in improving the 3 cardinal symptoms of CRS in CRS participants without nasal polyps, who had previously failed medical management.
Key facts
- Sponsor
- Lyra Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 5 Jun 2023 → 24 Mar 2025
- Decision date (initial)
- 2023-10-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Lyra Therapeutics Inc.
External identifiers
- EU CT number
- 2023-506268-15-00
- EudraCT number
- 2021-006911-27
- WHO UTN
- U1111-1297-0469
- ClinicalTrials.gov
- NCT05295459
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
The primary objective is to evaluate the efficacy of LYR-210, compared with a sham procedure control, in improving the 3 cardinal symptoms of CRS in CRS participants without nasal polyps, who had previously failed medical management.
Secondary objectives 2
- 1. Evaluate the efficacy of LYR-210, compared with a sham procedure, in improving the 3 cardinal symptoms of CRS in CRS participants without nasal polyps or with nasal polyps of grade 1, who had previously failed medical management.
- 2. Evaluate the efficacy of LYR-210, compared with sham control, in improving the individual CRS symptoms, CRS-related quality of life, the extent of inflammation in the ethmoid sinuses, and the need for rescue treatment in CRS participants without nasal polyps or with nasal polyps of Grade 1, who had previously failed medical management
Conditions and MedDRA coding
Chronic Rhinosinusitis (CRS) in Adults
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10009137 | Chronic sinusitis | 100000004862 |
Regulatory references
- Scientific advice from competent authorities
- Medicines And Healthcare Products Regulatory Agency, Food And Drug Administration
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- 1. Age ≥18.
- 2. Diagnosed as having CRS
- 3. Bilateral ethmoid disease confirmed on computed tomography (CT)
- 4. Mean 3 cardinal symptom (3CS) score
- 5. Undergone at least 2 trials of medical treatments in the past
- 6. Has been informed of the nature of the study and provided written informed consent
- 7. Agrees to comply with all study requirements.
- 8. Willing to cancel or be removed from waitlist for any preplanned elective sinonasal surgery for the duration of the study
Exclusion criteria 22
- 1. Inability to tolerate topical anesthesia
- 2. Previous nasal surgery or polypectomy within 3 months of screening
- 3. Presence of nasal polyp grade 2 or higher
- 4. Seasonal allergic rhinitis
- 5. Perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids
- 6. Severe asthma
- 7. Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy and CT
- 8. History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis
- 9. Anatomic variation that, in the opinion of the investigator, would adversely impact placement of LYR-210 as seen on CT
- 10. Known history of hypersensitivity or intolerance to corticosteroids
- 11. Known history of hypothalamic pituitary adrenal axial dysfunction
- 12. Previous pituitary or adrenal surgery
- 13. Dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
- 14. Past or present acute or chronic intracranial or orbital complications of CRS
- 15. History or diagnosis (in either eye) of glaucoma or ocular hypertension
- 16. Past or present functional vision in 1 or both eyes
- 17. Past, present, or planned organ transplant or chemotherapy with immunosuppression
- 18. Currently positive for COVID-19 or residual sinonasal symptoms from a previous COVID-19 infection
- 19. Pregnant or breast feeding. Females of child-bearing potential must test negative for pregnancy at the time of screening
- 20. Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments
- 21. Currently participating in an investigational drug or device study
- 22. Determined by the investigator as not suitable to be enrolled
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is the change from baseline (CFBL) in the 7-day average composite score of the 3 cardinal symptoms (3CS) of nasal blockage/obstruction/congestion, facial pain/pressure, and anterior/posterior nasal discharge at Week 24 in participant without nasal polyps.
Secondary endpoints 7
- 1.CFBL in the 7-day average composite score of 3CS at Week 24
- 2.CFBL in the 7-day average CS score of nasal blockage/obstruction/congestion at Week 24
- 3.CFBL in the 7-day average CS score of anterior/posterior nasal discharge at Week 24
- 4.CFBL in the 7-day average CS score of facial pain/pressure at Week 24
- 5.CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) total score at Week 24
- 6.Rescue treatment through Week 24
- 7. CFBL in the percent opacification of the bilateral anterior and posterior ethmoids at Week 20, as determined by 3-D volumetric CT analysis.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10384908 · Product
- Active substance
- Mometasone Furoate
- Other product name
- Mometasone Furoate & 9,21-Dichloro-11ß-hydroxy-16a-methyl-3,20- dioxopregna-1,4-dien-17-yl furan-2-carboxylate
- Pharmaceutical form
- POWDER FOR INHALATION
- Route of administration
- INTRANASAL USE
- Max daily dose
- 89 µg microgram(s)
- Max total dose
- 15000 µg microgram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- LYRA THERAPEUTICS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 1
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Lyra Therapeutics Inc.
- Sponsor organisation
- Lyra Therapeutics Inc.
- Address
- 480 Arsenal Way
- City
- Watertown
- Postcode
- 02472-2891
- Country
- United States
Scientific contact point
- Organisation
- Lyra Therapeutics Inc.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Lyra Therapeutics Inc.
- Contact name
- Clinical Trial Information
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Medpace Finland Oy ORG-100009147
|
Helsinki, Finland | On site monitoring, Code 10, Code 11, Code 12, Code 2, Interactive response technologies (IRT), Laboratory analysis, Data management, E-data capture, Code 8 |
Locations
5 EU/EEA countries · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 5 | 3 |
| Bulgaria | Ended | 24 | 4 |
| Germany | Ended | 30 | 5 |
| Hungary | Ended | 20 | 8 |
| Poland | Ended | 15 | 7 |
| Rest of world
United States
|
— | 90 | — |
Investigational sites
Universitair Ziekenhuis Gent
Department of Otolaryngology, Corneel Heymanslaan 10, 9000, Gent
Cliniques Universitaires Saint-Luc
Department of Otolaryngology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
UZ Leuven
Department of Otolaryngology, Herestraat 49, 3000, Leuven
Diagnostics-Consultancy Center Mladost M Varna OOD
Cabinet Ear, Nose and Throat, Bulevard Republika 15, 9020, Varna
University Multiprofile Hospital For Active Treatment Burgas AD
Department of Ear, Nose and Throat Diseases, Ulitsa Stefan Stambolov 73, 8000, Burgas
Military Medical Academy
Clinic of Ear, Nose and Throat Diseases, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofiya
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Clinic of Ear, Nose and Throat Diseases, Zapaden District, Sofia Str 64, Plovdiv
Technische Universitat Dresden
Klinik und Poliklinik für HNO- Heilkunde, Fetscherstrasse 74, Johannstadt-Nord, Dresden
HNO Landsberg
N/A, Zoerbiger Strasse 9, 06188, landsberg
HNO Zentrum am Kudamm
N/A, Giesebrechtstraße 7, 10629, Berlin-Charlottenburg
KIVITA GmbH
N/A, Am Gründelgraben 2, 76669, Bad Schönborn
Universitaetsklinikum Tuebingen AöR
Klinik für Hals-, Nasen- und Ohrenheilkunde, Elfriede-Aulhorn-Strasse 5, Nordstadt, Tuebingen
University Of Pecs
Fül-Orr-Gégészeti és Fej-Nyaksebészeti Klinika, Munkacsy Mihaly Utca 2, 7621, Pecs
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Fül- Orr- Gégészeti és Fej- Nyaksebészeti Osztály, Szent Istvan Utca 68, 4400, Nyiregyhaza
Central Hospital Of Northern Pest Military Hospital
Fül-orr-gége, Fej- és Nyaksebészeti Osztály, Podmaniczky Utca 109, 1062, Budapest VI
Bajcsy-Zsilinszky Korhaz Es Rendelointezet
Fül- Orr- Gégészeti és Fej-Nyaksebészeti Osztály, Maglodi Ut 89-91, Kerulet, Budapest
Budapesti Uzsoki Utcai Korhaz
Fül- orr- gége-, fej- nyak- sebészeti osztály, Uzsoki Utca 29-41, 1145, Budapest XIV
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz
Fül-Orr-Gégészeti Profil, Tetenyi Ut 12-16, XI Kerulet, Budapest
Szent Borbala Korhaz
Fül-Orr-Gégészeti Osztály, Dozsa Gyorgy Ut 77, 2800, Tatabanya
Semmelweis University
Fül-Orr-Gégészeti és Fej-Nyaksebészeti Klinika, Szigony Utca 36, 1083, Budapest Viii
Prywatna Praktyka Lekarska - Andrzej Sieśkiewicz
N/A, 42 Pułku Piechoty 125 lok. 3-4, 15-181, Białystok
Mazowiecki Szpital Brodnowski Sp. z o.o.
Zespół Oddziałów Otolaryngologii, Ul. Ludwika Kondratowicza 8, 03-242, Warsaw
Velocity Nova Sp. z o.o.
Velocity Lublin, Ul. Kazimierza Przerwy-Tetmajera 21, 20-362, Lublin
Promed P.Lach R.Glowacki Sp. j.
Centrum Medyczne Promed, Ul. Olszanska 5g, 31-513, Cracow
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Klinika Otorynolaryngologii, Ul. Woloska 137, 02-507, Warsaw
Farma-Med Kujawskie Centrum Medyczne Sp. z o.o.
N/A, Ul. Prezydenta Gabriela Narutowicza 24, 88-100, Inowroclaw
Vistamed & Vertigo Sp. z o.o.
N/A, Ul Raclawicka 105 1b, 53-149, Wroclaw
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 |
|---|---|---|---|---|---|
| Belgium | 2023-06-19 | 2025-01-21 | 2023-09-21 | 2024-10-08 | |
| Bulgaria | 2023-06-05 | 2025-03-21 | 2023-06-09 | 2024-10-08 | |
| Germany | 2023-07-17 | 2025-03-24 | 2023-08-21 | 2024-10-08 | |
| Hungary | 2023-07-28 | 2025-02-21 | 2023-08-02 | 2024-10-08 | |
| Poland | 2024-04-19 | 2025-04-02 | 2024-04-25 | 2024-10-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of results_2023-506268-15_Lyra Therapeutics SUM-107732
|
2025-11-25T15:50:56 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay Language Summary of final results | 2025-11-25T15:52:21 | Submitted | Laypersons Summary of Results |
Documents 110 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Lay Person_Summary of results_BG_2023-506268-15_Lyra | 1.0 |
| Laypersons summary of results (for publication) | Lay Person_Summary of results_DE_2023-506268-15_Lyra | 1.0 |
| Laypersons summary of results (for publication) | Lay Person_Summary of results_DU_2023-506268-15_Lyra | 1.0 |
| Laypersons summary of results (for publication) | Lay Person_Summary of results_EN_2023-506268-15_Lyra | 1.0 |
| Laypersons summary of results (for publication) | Lay Person_Summary of results_FR_2023-506268-15_Lyra | 1.0 |
| Laypersons summary of results (for publication) | Lay Person_Summary of results_HU_2023-506268-15_Lyra | 1.0 |
| Laypersons summary of results (for publication) | Lay Person_Summary of results_PL_2023-506268-15_Lyra | 1.0 |
| Protocol (for publication) | D1_Protocol Clarification Letter_2023-506268-15_Lyra_redacted | NA |
| Protocol (for publication) | D1_Protocol_2023-506268-15_Lyra_redacted | 4.0 |
| Protocol (for publication) | D4_Patient facing documents_ePRO_Lyra_Dutch | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_ePRO_Lyra_EN | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_ePRO_Lyra_French | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_ePRO_Lyra_German | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_ePRO_Lyra_HUN | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_PL_Lyra | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BE_LyraTherapeutics | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BG_LyraTherapeutics | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Germany_Lyra | n/a |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Hungary_Lyra Therapeutics Inc | 1.0 |
| Recruitment arrangements (for publication) | K2_DearColleagueLetter_Germany_Lyra_DE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitement material_Brochure_Lyra Therapeutics Inc | 1 |
| Recruitment arrangements (for publication) | K2_Recruitement material_Dear Colleague Letter_Lyra Therapeutics Inc | 1 |
| Recruitment arrangements (for publication) | K2_Recruitement material_Dear Participant Letter_Lyra Therapeutics Inc | 1 |
| Recruitment arrangements (for publication) | K2_Recruitement material_Participant Flyer_A3_Lyra Therapeutics Inc | 1 |
| Recruitment arrangements (for publication) | K2_Recruitement material_Participant Flyer_A4_Lyra Therapeutics Inc | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_DearColleagueLetter_BG_LyraTherapeutics | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_DearColleagueLetter_Dutch_LyraTherapeutics | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_DearColleagueLetter_English_LyraTherapeutics | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_DearColleagueLetter_French_LyraTherapeutics | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_DearColleagueLetter_PL_Lyra | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_DearParticipantLetter_BG_LyraTherapeutics | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_DearParticipantLetter_Dutch_LyraTherapeutics | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_DearParticipantLetter_English_LyraTherapeutics | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_DearParticipantLetter_French_LyraTherapeutics | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_DearParticipantLetter_PL_Lyra | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EnhancedBrochure_BG_LyraTherapeutics | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EnhancedBrochure_Dutch_LyraTherapeutics | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EnhancedBrochure_English_LyraTherapeutics | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EnhancedBrochure_French_LyraTherapeutics | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EnhancedBrochure_PL_Lyra | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ParticipantFlyer_BG_LyraTherapeutics | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ParticipantFlyer_Dutch_LyraTherapeutics | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ParticipantFlyer_English_LyraTherapeutics | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ParticipantFlyer_French_LyraTherapeutics | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ParticipantFlyer_PL_Lyra | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study reference card_Lyra Therapeutics Inc | HU V1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Dear participant letter_Lyra | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Enhanced Brochure_Lyra | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_ParticipantFlyer_Lyra | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Dutch_LyraTherapeutics | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ENG_Lyra Therapeutics Inc | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_English_LyraTherapeutics | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_French_LyraTherapeutics | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Lyra | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Lyra Therapeutics Inc_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main PIS_Lyra Therapeutics Inc_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Bulgaria_BG_LyraTherapeutics | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Bulgaria_EN_LyraTherapeutics | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Global_EN_LyraTherapeutics | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Lyra | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_Dutch_LyraTherapeutics | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_English_LyraTherapeutics | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_French_LyraTherapeutics | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ AncillarySupplies _Lyra | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ NeilMedSaline _Lyra | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ TermsandConditionsPolicy _Lyra | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Ancillary site supplies list_Lyra Therapeutics Inc | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Ancillary supplies_EN_LyraTherapeutics | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinSin Med Rinsing Douche_Lyra | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_ePRO screenshots_POL_Lyra Therepeutics Inc | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_NeilMed Saline Rinse_Lyra Therapeutics Inc | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_NeilMed Saline_DE_Lyra Therapeutics Inc | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_NeilMed Saline_ENG_Lyra Therapeutics Inc | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Emergency Card_Lyra Therapeutics Inc | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PatientEmergencyCard_Dutch_LyraTherapeutics | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PatientEmergencyCard_English_LyraTherapeutics | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PatientEmergencyCard_French_LyraTherapeutics | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PatientEmergencyContactCard_BG_LyraTherapeutics | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_PatientEmergencyContactCard_DE_Lyra Therapeutics Inc | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_PECard_ENG_Lyra Therapeutics Inc | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PECard_Lyra | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_PEContactCard_POL_Lyra Therapeutics Inc | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_QRG_BG_LyraTherapeutics | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_QRG_DE_Lyra Therepeutics Inc | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_QRG_Dutch_LyraTherapeutics | NA |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_QRG_ENG_Lyra Therepeutics Inc | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_QRG_English_LyraTherapeutics | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_QRG_French_LyraTherapeutics | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_QRG_Lyra | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_QRG_POL_Lyra Therepeutics Inc | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Quick Reference Guide_Lyra Therapeutics Inc | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Terms and Conditions_BG_LyraTherapeutics | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_TermsandCondition_Dutch_LyraTherapeutics | NA |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_TermsandConditions_DE_Lyra Therepeutics Inc | n/a |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_TermsandConditions_ENG_Lyra Therepeutics Inc | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_TermsandConditions_English_LyraTherapeutics | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_TermsandConditions_French_LyraTherapeutics | NA |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_TermsandConditions_POL_Lyra Therepeutics Inc | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_TrialBooster Consent to personal data processing | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_TrialBooster Cost reimbursement_Lyra Therapeutics Inc | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_TrialPACE_Terms andConditions and Cookies Policy | N/A |
| Summary of results (for publication) | Summary of results_2023-506268-15_Lyra Therapeutics | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ German_Belgium_2023-506268-15_Lyra | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Bulgarian_2023-506268-15_Lyra | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Dutch_Belgium_2023-506268-15_Lyra | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_English_2023-506268-15_Lyra | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_French_Belgium_2023-506268-15_Lyra | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Hungarian_2023-506268-15_Lyra | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Polish_2023-506268-15_Lyra | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Polish_2023-506268-15_Lyra_TC | 4.0 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-01 | Germany | Acceptable 2023-10-04
|
2023-10-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-15 | Germany | Acceptable 2024-01-15
|
2024-01-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-01-25 | Germany | Acceptable 2024-01-15
|
2024-01-25 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-01-29 | Acceptable 2024-01-15
|
2024-04-15 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-05-29 | Germany | Acceptable 2024-01-15
|
2024-05-29 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-27 | Germany | Acceptable 2024-09-23
|
2024-09-25 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-11-06 | Germany | Acceptable 2025-01-20
|
2025-01-21 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-02-17 | Germany | Acceptable | 2025-03-10 |