Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
80
Countries
3
Sites
18
EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer
Arms A and B: To evaluate whether enhanced dermatologic management can reduce incidence of Grade ≥2 DAEIs when compared with standard-of-care skin management in participants with locally advanced or metastatic Stage IIIB/C-IV EGFR-mutated NSCLC treated first-line with amivantamab and lazertinib Amivantamab SC Expansion…
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Mar 2024 → ongoing
- Decision date (initial)
- 2024-03-22
- 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: Prophylaxis, Efficacy, Therapy, Safety
Arms A and B: To evaluate whether enhanced dermatologic management can reduce
incidence of Grade ≥2 DAEIs when compared with standard-of-care skin
management in participants with locally advanced or metastatic Stage IIIB/C-IV EGFR-mutated NSCLC treated first-line with amivantamab and lazertinib
Amivantamab SC Expansion cohort: To estimate the incidence of Grade ≥2 DAEIs with modified enhanced dermatologic management and early intervention in participants with locally advanced or metastatic Stage IIIB/C-IV EGFR-mutated NSCLC treated first-line with amivantamab and lazertinib
Secondary objectives 1
- Amivantamab SC Expansion cohort: To estimate the incidence of Grade ≥2 DAEIs with modified enhanced dermatologic management and early intervention in participants with locally advanced or metastatic Stage IIIB/C-IV EGFR-mutated NSCLC treated first-line with amivantamab and lazertinib
Conditions and MedDRA coding
EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- 1. Be ≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater) at the time of informed consent.
- 2. Have histologically or cytologically confirmed, locally advanced or metastatic NSCLC that is treatment-naïve and not amenable to curative therapy including surgical resection or (chemo)radiation. Adjuvant or neoadjuvant therapy for Stage I or Stage II disease is allowed if administered more than 12 months prior to the development of locally advanced or metastatic disease.
- 3. Have a tumor that harbors an EGFR exon 19del or exon 21 L858R substitution, as detected by an FDA-approved or other validated test in a CLIA-certified laboratory (sites in the United States) or an accredited local laboratory (sites outside of the United States) in accordance with site standard of care. (Note: A copy of the test report documenting the EGFR mutation must be included in the participant records.)
- 4. Participants with a history of brain metastases must have had all lesions treated as clinically indicated (ie, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization, and the participant can be receiving no greater than 10 mg prednisone or equivalent daily for the treatment of intracranial disease.
- 6. Have an ECOG performance status of 0 to 1 (Appendix 7: Eastern Cooperative Oncology Group (ECOG) Performance Scale).
- 14. A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of amivantamab or lazertinib.
- Sub-study: Participants must have new-onset or persistent (defined as non-responsive to standard of care [SoC]) Grade >=2 specific DAEIs of the scalp, face, or body, as defined by NCI CTCAE Grading v5.0 for DAEIs (excluding paronychia)
Exclusion criteria 8
- 1. History of uncontrolled illness, including but not limited to - Uncontrolled diabetes - Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week prior to starting background anticancer treatment] or diagnosed or suspected viral infection. For the amivantamab SC Expansion cohort, this includes active localized serious infections. - Active bleeding diathesis - Impaired oxygenation requiring continuous oxygen supplementation - Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of background anticancer treatment or doxycycline/minocycline - Psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements - Any ophthalmologic condition that is clinically unstable - Pre-existing skin condition that would prevent adequate evaluations of dermatologic toxicity, as determined by the investigator
- 2. Medical history of ILD, including drug-induced ILD or radiation pneumonitis
- 3. Known allergy, hypersensitivity, or intolerance to the excipients of amivantamab, lazertinib, or to tetracyclines, doxycycline, minocycline, timolol*, ruxolitinib*, zinc*, corticosteroids* or their excipients or to any component of the enhanced dermatologic management (refer to the IBs or product labels). NOTE: For the amivantamab SC Expansion cohort, participants with known allergies, hypersensitivity, intolerance to excipients or contraindications to propranolol will not be excluded from the study. However, if these participants experience scalp DAEIs during the study, propranolol should not be initiated. Participants should receive treatment with clobetasol 0.05% shampoo only. *Only applicable for participants to be included in the amivantamab SC expansion cohort
- 4. History of clinically significant cardiovascular disease including, but not limited to, the following: - Diagnosis of deep vein thrombosis or pulmonary embolism within 1 month prior to the first dose of background anticancer treatment(s), or any of the following within 6 months prior to the first dose of background anticancer treatment(s): myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis, such as non-obstructive catheterassociated clots, are not exclusionary. - Significant genetic predisposition to VTEs such as Factor V Leiden. - Prior history of VTE and is not on appropriate therapeutic anticoagulation as per NCCN or local guidelines. Participants with history of VTE K1 month prior to the first dose of background anticancer treatment and on appropriate therapeutic anticoagulation may be eligible. - Prolonged QTcF interval >480 msec or clinically significant cardiac arrhythmia or electrophysiologic disease (eg, placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate). - Uncontrolled (persistent) hypertension: systolic blood pressure >160 mmHg; diastolic blood pressure >100 mm Hg. - Congestive heart failure, defined as NYHA class III-IV or hospitalization for congestive heart failure (any NYHA class) within 6 months of treatment initiation at C1D1 (Appendix 10: New York Heart Association (NYHA) Criteria). - Pericarditis/clinically significant pericardial effusion. - Myocarditis. - Baseline LVEF below the institution’s lower limit of normal at screening, as assessed by echocardiogram or MUGA scan.
- 6. Participant has received any prior systemic treatment at any time for locally advanced Stage III or metastatic Stage IV disease (adjuvant or neoadjuvant therapy for Stage or II disease is allowed if administered more than 12 months prior to the development of locally advanced or metastatic disease).
- 7. Participant has an active or past medical history of leptomeningeal disease.
- 12. Has received any prior treatment with an EGFR TKI for metastatic or unresectable disease (adjuvant treatment with osimertinib is allowed if administered more than 12 months prior to the development of locally advanced or metastatic disease and all osimertinib toxicities are resolved prior to enrollment).
- Sub-study: Participants who have received prior treatment for epidermal growth factor receptor (EGFR)-induced DAEIs with JAK inhibitors (for Cohort A) or calcineurin inhibitors (for Cohort B)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Incidence of Grade ≥2 DAEIs (Appendix 17: Dermatologic Adverse Events of Interest: Preferred Terms) in the first 12 weeks after initiation of amivantamab and lazertinib treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 18
PRD9813175 · Product
- Active substance
- Amivantamab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10500854 · Product
- Active substance
- Ruxolitinib
- Pharmaceutical form
- CREAM
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 0 g gram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- D11AH09 — -
- Marketing authorisation
- EU/1/23/1726/002
- MA holder
- INCYTE BIOSCIENCES DISTRIBUTION B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The commercial ruxolitinib 1.5% (15mg/g) cream remains packed in the original primary packaging material. The vials are labeled with a clinical label booklet, repackaged in the original commercial carton with another clinical label booklet and released for use in the clinical trial.
PRD391421 · Product
- Active substance
- Minocycline Hydrochloride
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 g gram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01AA08 — MINOCYCLINE
- Marketing authorisation
- 022240129
- MA holder
- TEOFARMA S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD4241236 · Product
- Active substance
- Tacrolimus Monohydrate
- Pharmaceutical form
- OINTMENT
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 0 g gram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- D11AH01 — -
- Marketing authorisation
- EU/1/02/201/004
- MA holder
- LEO PHARMA A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The commercial tacrolimus 0.01% ointment remains packed in the original primary packaging material. The vials are labeled with a clinical label booklet, repackaged in the original commercial carton with another clinical label booklet and released for use in the clinical trial.
PRD4241235 · Product
- Active substance
- Tacrolimus Monohydrate
- Pharmaceutical form
- OINTMENT
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 0 g gram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- D11AH01 — -
- Marketing authorisation
- EU/1/02/201/003
- MA holder
- LEO PHARMA A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The commercial tacrolimus 0.01% ointment remains packed in the original primary packaging material. The vials are labeled with a clinical label booklet, repackaged in the original commercial carton with another clinical label booklet and released for use in the clinical trial.
Timolol Micro Labs 5 mg/ml Augentropfen, Losung
PRD6641790 · Product
- Active substance
- Timolol Maleate
- Pharmaceutical form
- EYE DROPS, SOLUTION
- Route of administration
- TOPICAL ADMINISTRATION
- Max daily dose
- 0 g gram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- S01ED01 — TIMOLOL
- Marketing authorisation
- 99191.00.00
- MA holder
- MICRO LABS GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Timolol 0,5 % AT - 1 A Pharma, 5 mg/ml Augentropfen, Lösung
PRD805989 · Product
- Active substance
- Timolol Maleate Ph. Eur.
- Pharmaceutical form
- EYE DROPS, SOLUTION
- Route of administration
- TOPICAL APPLICATION
- Max daily dose
- 0 g gram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- S01ED01 — TIMOLOL
- Marketing authorisation
- 8984.02.00
- MA holder
- 1 A PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Doxy-M-ratiopharm 100 mg tabletės
PRD599357 · Product
- Active substance
- Doxycycline Monohydrate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01AA02 — DOXYCYCLINE
- Marketing authorisation
- LT/1/94/0272/001
- MA holder
- RATIOPHARM GMBH
- MA country
- Lithuania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Doxy-M-ratiopharm® 100 mg Tabletten
PRD657157 · Product
- Active substance
- Doxycycline Monohydrate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01AA02 — DOXYCYCLINE
- Marketing authorisation
- 16390.00.00
- MA holder
- RATIOPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD12006715 · Product
- Active substance
- Doxycycline Monohydrate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 g gram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01AA02 — DOXYCYCLINE
- Marketing authorisation
- 11619.00.00
- MA holder
- DERMAPHARM AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dalacin 10 mg emulsión cutánea
PRD467644 · Product
- Active substance
- Clindamycin
- Pharmaceutical form
- CUTANEOUS EMULSION
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 0 g gram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- D10AF01 — CLINDAMYCIN
- Marketing authorisation
- 58.782
- MA holder
- PFIZER S.L.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Zink Verla® 10 mg, Filmtabletten
PRD11669946 · Product
- Active substance
- Zinc Gluconate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 g gram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- A12CB02 — ZINC GLUCONATE
- Marketing authorisation
- 36475.00.00
- MA holder
- VERLA-PHARM ARZNEIMITTEL GMBH & CO. KG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Minocyclin-ratiopharm® 100 mg Hartkapseln
PRD599943 · Product
- Active substance
- Minocycline Hydrochloride
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01AA08 — MINOCYCLINE
- Marketing authorisation
- 6801059.01.00
- MA holder
- RATIOPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD12006367 · Product
- Active substance
- Propranolol Hydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 g gram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- C07AA05 — PROPRANOLOL
- Marketing authorisation
- 6328947.02.00
- MA holder
- MIBE GMBH ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11078981 · Product
- Active substance
- Amivantamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10854158 · Product
- Active substance
- Chlorhexidine Digluconate Solution
- Pharmaceutical form
- CUTANEOUS SOLUTION
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 0 ml millilitre(s)
- Max total dose
- 0 ml millilitre(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
ClobeGalen 500 Mikrogramm/g Shampoo
PRD10222046 · Product
- Active substance
- Clobetasol Propionate Ph.eur.
- Pharmaceutical form
- SHAMPOO
- Route of administration
- TOPICAL APPLICATION
- Max daily dose
- 0 g gram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- D07AD01 — CLOBETASOL
- Marketing authorisation
- 7006694.00.00
- MA holder
- GALENPHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10153788 · Product
- Active substance
- Lazertinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Mapi Research Trust ORG-100028136
|
London, United Kingdom | Other |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Ancillare LP ORG-100044089
|
Horsham, United States | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | Data management |
Locations
3 EU/EEA countries · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 6 | 3 |
| Germany | Ongoing, recruitment ended | 3 | 6 |
| Spain | Ongoing, recruitment ended | 6 | 9 |
| Rest of world
Turkey, Malaysia, China, Taiwan, United States, Brazil, Argentina, Korea, Republic of
|
— | 65 | — |
Investigational sites
Assistance Publique Hopitaux De Marseille
Oncologie multidisciplinaire et innovations thérapeutiques, 265 Chemin Des Bourrely, 13015, Marseille
Institut Curie
Pneumology, 26 Rue D Ulm, 75005, Paris
Centre Hospitalier Universitaire De Nice
Pneumology, Thoracic Oncology & Intensive Respiratory Care, 30 Voie Romaine, 06000, Nice
KEM I Evang. Kliniken Essen-Mitte gGmbH
Klinik für Internistische Onkologie mit Integrierter Palliativmedizin, Henricistrasse 92, Huttrop, Essen
Thoraxklinik Heidelberg gGmbH
Onkologie der Thoraxtumoren, Roentgenstrasse 1, Rohrbach, Heidelberg
Justus-Liebig-Universitaet Giessen
Medizinische Klinik IV und V, Gaffkystrasse 5, 35392, Giessen
Universitaetsklinikum Aachen AöR
Medizinische Klinik IV, Pauwelsstrasse 30, 52074, Aachen
Klinikum Kassel GmbH
Klinik für Haematologie, Onkologie und Immunologie, Moenchebergstrasse 41-43, Fasanenhof, Kassel
Universitaetsklinikum Schleswig-Holstein
Klinik fuer Innere Medizin II, Arnold-Heller-Strasse 3, Brunswik, Kiel
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital General Universitario Dr. Balmis
Oncology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Universitario Lucus Augusti
Oncology, Rua Dr. Ulises Romero 1, 27003, Lugo
Hospital Universitario De Jaen
Oncology, Avenida Del Ejercito Espanol 10, 23007, Jaen
Hospital Universitario Virgen De Valme
Oncology, Avenida Bellavista S/n, 41014, Sevilla
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Complexo Hospitalario Universitario A Coruna
Medical Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
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 |
|---|---|---|---|---|---|
| France | 2024-04-08 | 2024-04-10 | 2026-04-20 | ||
| Germany | 2024-04-23 | 2024-06-05 | 2026-04-20 | ||
| Spain | 2024-03-20 | 2024-04-30 | 2026-04-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 68 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | Procedure Number Clarification_2023-505863-35-00 | 1 |
| Clinical study report (for publication) | REDACTED_CSR_2023-505863-35-00 | 1 |
| Clinical study report (for publication) | Study Anonymization Report_2023-505863-35-00 | 1.1 |
| Protocol (for publication) | D1_REDACTED_Protocol Clarification 2 2023-505863-35 | 1 |
| Protocol (for publication) | D1_REDACTED_Protocol Clarification 2023-505863-35 | 1 |
| Protocol (for publication) | D4_PF Placeholder EORTC QLQ-C30_ENG_61186372NSC2007 | 1 |
| Protocol (for publication) | D4_PF Placeholder Skindex16_ENG_61186372NSC2007 | 1 |
| Protocol (for publication) | PLACEHOLDER_D4_PF EQ-5D-5L Interviewer_multilingual_2023-505863-35 | 1 |
| Protocol (for publication) | PLACEHOLDER_D4_PF EQ-5D-5L Self-Complete_multilingual_2023-505863-35 | 1 |
| Protocol (for publication) | REDACTED_D1_Protocol_2023-505863-35 | Am5 |
| Protocol (for publication) | REDACTED_D4_Patient facing document eDiary_FR_FR_61186372NSC2007 | 2 |
| Protocol (for publication) | REDACTED_D4_Patient facing document ePRO PGIS_FR_FR_61186372NSC2007 | 1 |
| Protocol (for publication) | REDACTED_D4_Patient facing document PRO PGIS_DE_GER_61186372NSC2007 | 1 |
| Protocol (for publication) | REDACTED_D4_Patient facing document PRO PGIS_ENG_61186372NSC2007 | 1 |
| Protocol (for publication) | REDACTED_D4_Patient facing document Subject eDiary_DE_GER_61186372NSC2007 | 1 |
| Protocol (for publication) | REDACTED_D4_Patient facing document Subject eDiary_ENG_61186372NSC2007 | 2 |
| Protocol (for publication) | REDACTED_D4_Patient facing document_eDiary Questions_ES_SPA_61186372NSC2007 | 2 |
| Protocol (for publication) | REDACTED_D4_Patient facing document_PGIS_ES_SPA_2023-505863-35 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Subject eDiary_DE_GER_2023-505863-35 | 2 |
| Protocol (for publication) | REDACTED_D4_PF Subject eDiary_ES_SPA_2023-505863-35 | 2 |
| Protocol (for publication) | REDACTED_D4_PF Subject eDiary_FR_FRE_2023-505863-35 | 2 |
| Protocol (for publication) | REDACTED_D4_PF Subject eDiary_multicountry_eng_2023-505863-35 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _FR_FR_61186372NSC2007 | 3 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_DE_ENG_61186372NSC2007 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_ES_EN_61186372NSC2007 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment materials_FAQ_ES_ES_61186372NSC2007 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material FAQ Document_DE_GER_61186372NSC2007 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material FAQ Document_FR_FR_61186372NSC2007 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 2 to Clinical ICF v5_DE_GER_2023-505863-35 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical 4 Addendum 1_ES_SPA_2023-505863-35 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical 7 Addendum 1_ES_SPA_2023-505863-35 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical ICF Addendum 1_DE_GER-2023-505863-35 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical Informed Consent_DE_GER_2023-505863-35 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_ES_SPA_2023-505863-35 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Addendum_ES_SPA_2023-505863-35 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sub Study_ES_SPA_2023-505863-35 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sub-Study Informed Consent_DE_GER_2023-505863-35 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy Informed Consent_DE_GER_2023-505863-35 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_ES_SPA_2023-505863-35 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal Informed Consent_DE_GER_2023-505863-35 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_ES_SPA_2023-505863-35 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum 2_FR_FRE_2023-505863-35 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum_FR_FRE_2023-505863-35 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main Addendum 3_FR_FRE_22023-505863-35 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main v5_Addendum 1_FR_FRE_22023-505863-35 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_FR_FRE_2023-505863-35 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner_FR_FRE_2023-505863-35 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Substudy_FR_FRE_2023-505863-35 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal_FR_FR_61186372NSC2007 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DE_GER_2023-505863-35 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_ES_SPA_2023-505863-35 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_FR_FRE_2023-505863-35 | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC Propanolol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC Zinc gluconate | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC_Clobetasol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC_Minocycline 50mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC_Timolol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Clindamycin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Doxycycline DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Doxycycline LT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Minocycline | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ruxolitinib | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Tacrolimus | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Timolol_Micro Labs | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Doxycycline 50mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_US PI Chlorhexidine Betasept | 1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_ES_SPA_2023-505863-35 | AM5 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_FR_FR_2023-505863-35 | Am5 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-10 | Spain | Acceptable 2024-03-18
|
2024-03-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-25 | Spain | Acceptable | 2024-04-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-17 | Acceptable | 2024-05-23 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-30 | Spain | Acceptable 2024-10-08
|
2024-10-08 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-04 | Acceptable | 2025-01-22 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-05 | Acceptable | 2024-12-19 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-21 | Spain | Acceptable 2025-06-20
|
2025-06-20 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-08-14 | Spain | Acceptable 2025-10-23
|
2025-10-24 |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-12-29 | Spain | Acceptable 2026-03-14
|
2026-03-16 |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-04-20 | Acceptable | 2026-05-29 |