Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
84
Countries
1
Sites
10
Moderate to severe chronic hand eczema
To evaluate the efficacy of abrocitinib in subjects with moderate to severe CHE
Key facts
- Sponsor
- Innovaderm Research Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 20 Oct 2024 → 4 Nov 2025
- Decision date (initial)
- 2024-06-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Innovaderm Research Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Others
To evaluate the efficacy of abrocitinib in subjects with moderate to severe CHE
Secondary objectives 2
- To evaluate the efficacy of abrocitinib in subjects with moderate to severe CHE in Part A
- To evaluate the safety and tolerability of abrocitinib in subjects with moderate to severe CHE
Conditions and MedDRA coding
Moderate to severe chronic hand eczema
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | LLT | 10084778 | Chronic hand eczema | 100000004848 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Part A and Part B The study includes a screening period of up to 30 days, a 32-week treatment period, and a 4-week follow-up period after administration of the last dose of study drug for a total study duration of up to approximately 40 weeks for each participant. Abrocitinib and placebo are available as tablets. Participants will be randomized in a 1:1:1 ratio to one of the following treatment regimens:
• Part A: abrocitinib 200 mg (16-week treatment); Part B: abrocitinib 200 mg (16-week
treatment);
• Part A: abrocitinib 100 mg (16-week treatment); Part B: abrocitinib 100 mg (16-week
treatment);
• Part A: placebo (16-week treatment); Part B: abrocitinib 200 mg (16-week treatment). Subjects who were assigned to placebo in Part A (first 16 weeks) of the study will receive
abrocitinib 200 mg during Part B (up to Week 32). Subjects who were assigned to abrocitinib
200 mg or 100 mg, in Part A will continue on the same dose regimen during Part B of the study
(up to Week 32).
|
Randomised Controlled | Double | [{"id":149190,"code":1,"name":"Subject"},{"id":149192,"code":5,"name":"Carer"},{"id":149191,"code":3,"name":"Monitor"},{"id":149193,"code":2,"name":"Investigator"}] | Abrocitinib active substance: 200mg Abrocitinib orally once daily for 16 weeks, 200mg Abrocitinib orally once daily up to week 32 Abrocitinib active substance: 100mg Abrocitinib orally once daily for 16 weeks once, 100mg Abrocitinib orally once daily up to week 32 Placebo: 100mg Placebo orally once daily for 16 weeks, 200mg Abrocitinib orally once daily up to week 32 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Adult subject, 18 years of age or older, at the time of consent.
- Subject has a history of moderate to severe CHE for at least 6 months prior to Day 1.
- Subject has refractory hand eczema.
- Subject has moderate to severe CHE at screening and Day 1, as defined by a hand PGA of 3 or 4.
- Contraceptive use by women of childbearing potential or their male partners during the study and until ≥ 4 weeks after the last study product administration.
Exclusion criteria 5
- Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
- Subject has a history or has current active psoriasis.
- Subject has a history of eczema herpeticum within 12 months prior to screening, and/or a history of 2 or more episodes of eczema herpeticum in the past.
- Subject has any clinically significant medical condition (including psychiatric condition) or physical/laboratory/vital signs abnormality.
- Subject has known or suspected allergic contact dermatitis of the hands and is unable to avoid exposure to the causative allergen or subjects with suspected or expected changes in irritant or allergen exposures from screening through the end of the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percent change from baseline in hand mTLSS at Week 16
Secondary endpoints 13
- Percent change from baseline in hand mTLSS at Weeks 2, 4, and 12
- Proportion of subjects achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in hand PGA at Weeks 2, 4, 12, and 16
- Proportion of subjects achieving at least a 2-grade reduction from baseline in hand PGA at Weeks 2, 4, 12, and 16
- Percent change from baseline in HESCI at Weeks 2, 4, 12, and 16
- Percent change from baseline in Extent of Disease affected with moderate to severe CHE at Weeks 2, 4, 12 and 16.
- Actual PaGA measeruments at Weeks 2, 4, 12 and 16
- Percent change from baseline in hand DLQI at Weeks 2, 4, 12 and 16
- Percent change from baseline in QOLHEQ at Weeks 2, 4, 12 and 16
- Percent change from baseline in pain NRS at Weeks 2, 4, 12 and 16
- Percent change from baseline in itch NRS at Weeks 2, 4, 12 and 16
- Number of TEAEs
- Number of treatment-related TEAEs
- Vital signs and safety laboratory tests
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Cibinqo 100 mg film-coated tablets
PRD9364385 · Product
- Active substance
- Abrocitinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 44800 mg milligram(s)
- Max treatment duration
- 32 Week(s)
- Authorisation status
- Authorised
- ATC code
- D11AH08 — -
- Marketing authorisation
- EU/1/21/1593/007
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The 100 mg tablets to be used in this CTA are clinical image of the commercial product. The only difference is the tablet appearance. The appearance of 100 mg commercial tablet is “Round pink film-coated tablet debossed with ABR 100 on one side and PFE on the other”, while the clinical tablet is “Round, white, film-coated tablet”.
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
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Innovaderm Research Inc.
- Sponsor organisation
- Innovaderm Research Inc.
- Address
- 3530 Saint-Laurent Boulevard Suite 300
- City
- Montreal
- Postcode
- H2X 2V1
- Country
- Canada
Scientific contact point
- Organisation
- Innovaderm Research Inc.
- Contact name
- Scientific Affairs Department
Public contact point
- Organisation
- Innovaderm Research Inc.
- Contact name
- Scientific Affairs Department
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Laboratory of Inflammatory Skin Diseases ORL-000005436
|
New York, United States | Laboratory analysis |
| Quipment ORG-100043496
|
Nancy, France | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Interactive response technologies (IRT) |
| PCI Pharma Services Germany GmbH ORG-100031981
|
Großbeeren, Germany | Code 14 |
| Transperfect Translations International Inc. ORG-100043494
|
New York, United States | Other |
| PCI ORL-000004779
|
Rockford, United States | Code 14 |
| CIRION Biopharma Research Inc. ORG-100016262
|
Laval, Canada | Laboratory analysis |
| Millmount Healthcare Limited ORG-100011724
|
Stamullen, Ireland | Code 14 |
| LKF Laboratorium fuer Klinische Forschung GmbH ORG-100017343
|
Schwentinental, Germany | Laboratory analysis |
| Medrio Inc. ORG-100045869
|
San Francisco, United States | E-data capture |
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 70 | 10 |
| Rest of world
Canada
|
— | 14 | — |
Investigational sites
Dermmedica Sp. z o.o.
Dermatology, Ul. Krzysztofa Kolumba 6, 51-503, Wroclaw
DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski, s.c.
Dermatology, ul. Tuberozy 3, 86-031, Osielsko
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Dermatology, Ul. Na Zaspe 3, 80-546, Gdansk
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Dermatology, Ul. Woloska 137, 02-507, Warsaw
St-Inspire Sp. z o.o.
Dermatology, Ul. Pszczynska 12b/1, 43-190, Mikolow
Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki
Dermatology, Al. Piastow 65/U5, 70-332, Szczecin
Dermed Centrum Medyczne Sp. z o.o.
Dermatology, Ul. Piotrkowska 48, 90-265, Lodz
Specderm Poznanska Sp. j.
Dermatology, Ul. Prezydenta Ryszarda Kaczorowskiego 7/u 50, 15-375, Bialystok
Luxderm Specjalistyczny Gabinet Dermatologiczny
Dermatology, ul. Szafirowa 15/lok.45, 20-573, Lublin
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy Marek Brzewski Paweł Brzewski s.c.
Dermatology, ul. Zbozowa 2/25, 30-002, Krakow
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 |
|---|---|---|---|---|---|
| Poland | 2024-10-20 | 2025-11-03 | 2024-10-20 | 2025-02-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-504539-42_for publication | 1.1 |
| Protocol (for publication) | D2_Protocol Clarification Letter 1_for publication | NA |
| Protocol (for publication) | D2_Protocol Clarification Letter 2_for publication | NA |
| Protocol (for publication) | D2_Protocol Clarification Letter 3_for publication | NA |
| Protocol (for publication) | D4_Patient facing documents_DLQI_for publication | NA |
| Protocol (for publication) | D4_Patient facing documents_PaGA_for publication | NA |
| Protocol (for publication) | D4_Patient facing documents_Pain NRS_for publication | NA |
| Protocol (for publication) | D4_Patient facing documents_Pruritus NRS_for publication | NA |
| Protocol (for publication) | D4_Patient facing documents_QOLHEQ_for publication | NA |
| Protocol (for publication) | D4_Patient facing documents_WPAI-SHP_for publication | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_PL_for publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy and Newborn Follow-up_PL_for publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_PL_for publication | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Emergency Card_PL_for publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject Diary Paper_PL_for publication | 2.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2023-504539-42_for publication | 1.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-22 | Poland | Acceptable 2024-06-03
|
2024-06-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-29 | Poland | Acceptable 2024-06-03
|
2024-08-29 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-01 | Poland | Acceptable 2024-06-03
|
2025-10-01 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-02 | Poland | Acceptable 2025-11-12
|
2025-11-12 |