Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
250
Countries
2
Sites
13
atopic dermatitis
To determine the effect of SCD-044 treatment on moderate to severe atopic dermatitis, as measured by proportion of subjects showing at least 75% improvement in Eczema Area and Severity Index (EASI) at Week 16.
Key facts
- Sponsor
- Sun Pharmaceutical Industries Limited
- 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
- 25 Aug 2023 → 14 Mar 2025
- Decision date (initial)
- 2024-10-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Sun Pharmaceutical Industries Limited, India
External identifiers
- EU CT number
- 2024-511615-16-00
- EudraCT number
- 2022-001934-12
- WHO UTN
- U1111-1289-7887
- ClinicalTrials.gov
- NCT04684485
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Pharmacokinetic, Therapy, Safety, Efficacy, Pharmacodynamic
To determine the effect of SCD-044 treatment on moderate to severe atopic dermatitis, as measured by proportion of subjects showing at least 75% improvement in Eczema Area and Severity Index (EASI) at Week 16.
Conditions and MedDRA coding
atopic dermatitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10003639 | Atopic dermatitis | 10040785 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Aged at least 18 years.
- Males and non-pregnant non-lactating females, diagnosed with chronic atopic dermatitis for ≥ 1 year at Screening and Baseline based on Eichenfield revised criteria of Hanifin and Rajka
- Moderate to severe atopic dermatitis at Screening and Baseline
Exclusion criteria 3
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation or within 6 months of completing the study.
- Known organ complications of Diabetes mellitus such as reduced renal function, significant retinal pathology or neuropathy
- History or presence of uveitis
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of subjects who achieve ≥75% overall improvement in EASI score from Baseline
Secondary endpoints 1
- Proportion of subjects who achieve score of '0' or '1' on a 5-point, vIGA scale and ≥2 point reduction from Baseline to Week 16
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD10343127 · Product
- Active substance
- Vibozilimod
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 1.0 mg milligram(s)
- Max total dose
- 224 mg milligram(s)
- Max treatment duration
- 32 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- L04AA — SELECTIVE IMMUNOSUPPRESSIVE AGENTS
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES
- Paediatric formulation
- No
- Orphan designation
- No
PRD10343136 · Product
- Active substance
- Vibozilimod
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0.1 mg milligram(s)
- Max total dose
- 22.4 mg milligram(s)
- Max treatment duration
- 32 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- L04AA — SELECTIVE IMMUNOSUPPRESSIVE AGENTS
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES
- Paediatric formulation
- No
- Orphan designation
- No
PRD10343092 · Product
- Active substance
- Vibozilimod
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0.3 mg milligram(s)
- Max total dose
- 67.2 mg milligram(s)
- Max treatment duration
- 32 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- L04AA — SELECTIVE IMMUNOSUPPRESSIVE AGENTS
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES
- Paediatric formulation
- No
- Orphan designation
- No
PRD10343107 · Product
- Active substance
- Vibozilimod
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0.6 mg milligram(s)
- Max total dose
- 134.4 mg milligram(s)
- Max treatment duration
- 32 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- L04AA — SELECTIVE IMMUNOSUPPRESSIVE AGENTS
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
placebo to match SCD-044 tablets
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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sun Pharmaceutical Industries Limited
- Sponsor organisation
- Sun Pharmaceutical Industries Limited
- Address
- 1 Plot No 201 B, Western Express Highway, Goregaon East Western Express Highway Goregaon East
- City
- Mumbai
- Postcode
- 400063
- Country
- India
Scientific contact point
- Organisation
- Sun Pharmaceutical Industries Limited
- Contact name
- Vasu Sadashivam
Public contact point
- Organisation
- Sun Pharmaceutical Industries Limited
- Contact name
- Vasu Sadashivam
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Acm Global Central Laboratory Limited ORG-100042459
|
York, United Kingdom | Other |
| Bioclinica Shanghai Co. Ltd. ORG-100049318
|
Shanghai, China | Other |
| Psi Cro AG ORG-100034251
|
Zug, Switzerland | On site monitoring, Code 12, Code 2, Code 8 |
| Canfield Scientific Inc. ORG-100042834
|
Parsippany, United States | Other |
| Sun Pharmaceutical Industries (Europe) B.V. ORG-100001121
|
Hoofddorp, Netherlands | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Syneos Health Clinique Inc. ORG-100028348
|
Quebec, Canada | Other |
| Veranex Inc. ORG-100046478
|
Raleigh, United States | Data management |
| Trialogics LLC ORG-100047835
|
Wilmington, United States | Interactive response technologies (IRT) |
| Biostudy Solutions, LLC ORL-000002794
|
United States | Code 10 |
| Fisher Clinical Services GmbH ORG-100017323
|
Rheinfelden (Baden), Germany | Code 14 |
Locations
2 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Estonia | Ended | 4 | 1 |
| Poland | Ended | 39 | 12 |
| Rest of world
Georgia, El Salvador, United States
|
— | 207 | — |
Investigational sites
Kliiniliste Uuringute Keskus OÜ
N/A, Sobra Tn 54/1, 50106, Tartu Linn
"LANDA” Katarzyna Agata Landa
„LANDA” Specjalistyczne Gabinety Lekarskie, ul. Zacisze 4/1, 31-156, Kraków
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
Centrum Nowoczesnych Terapii „Dobry Lekarz” Spółka z Ograniczoną Odpowiedzialnością, Plac Szczepanski 3, 31-011, Cracow
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Klinika Dermatologii, Ul. Woloska 137, 02-507, Warsaw
EMC Instytut Medyczny S.A.
Prywatna Lecznica "Certus" Szpital nr 1, Ul. Grunwaldzka 156, 60-309, Poznan
Globe Badania Kliniczne Sp. z o.o.
GLOBE Clinical Research, Ul. Janusza Kusocinskiego 3a, 57-300, Klodzko
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
„Twoja Przychodnia SCM”, Al. Wyzwolenia 46/16u, 71-500, Szczecin
Appletreeclinics Network Sp. z o.o.
Appletreeclinics Ośrodek Badań Klinicznych, Ul. Ks. Bp. Wincentego Tymienieckiego 20, 90-349, Lodz
Synexus Polska Sp. z o.o.
Synexus Polska Sp. z o.o. Oddział w Gdańsku, Ul. Maurycego Beniowskiego 23, 80-382, Gdansk
Klimed MK Sp. z o.o.
KLIMED Marek Klimkiewicz, Aleja Jana Pawla II 59/6u, 15-704, Bialystok
Synexus Polska Sp. z o.o.
Synexus Polska Sp. Z o.o. Oddział we Wrocławiu, Ul. Marii Curie-Sklodowskiej 12, 50-381, Wroclaw
Dermedic Iwona Zdybska
DERMEDIC Iwona Zdybska, ul. Konrada Wallenroda 4c/6, 20-607, Lublin
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Poradnia Dermatologiczna CWBK, Ulica Szaserow 128, 04-141, Warsaw
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 |
|---|---|---|---|---|---|
| Estonia | 2023-09-21 | 2024-11-25 | 2023-11-20 | 2024-05-24 | |
| Poland | 2023-08-25 | 2025-03-11 | 2023-10-17 | 2024-06-18 |
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 SUM-118413
|
2026-02-09T12:52:23 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay Person Summary of Results | 2026-02-09T13:01:06 | Submitted | Laypersons Summary of Results |
| Lay Person Summary of Results | 2026-02-09T13:00:40 | Submitted | Laypersons Summary of Results |
| Lay Person Summary of Results | 2026-02-09T13:00:24 | Submitted | Laypersons Summary of Results |
| Lay Person Summary of Results | 2026-02-09T13:00:03 | Submitted | Laypersons Summary of Results |
Documents 15 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 | N/A |
| Laypersons summary of results (for publication) | Lay Person Summary of Results | N/A |
| Laypersons summary of results (for publication) | Lay Person Summary of Results | N/A |
| Laypersons summary of results (for publication) | Lay Person Summary of Results | N/A |
| Protocol (for publication) | D1_Protocol_2024-511615-16-00_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_placeholder | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_placeholder for publication | N/A |
| Subject information and informed consent form (for publication) | L1_ICF_Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Photo Release_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnancy_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_EE_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_RU_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_EE_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_RU_Redacted | 2.1 |
| Summary of results (for publication) | Summary of Results_Redacted | N/A |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-13 | Poland | Acceptable 2024-10-10
|
2024-10-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-24 | Poland | Acceptable 2024-10-10
|
2024-10-24 |