Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
240
Countries
2
Sites
12
moderate to severe plaque psoriasis
To determine the effect of SCD-044 treatment on moderate to severe plaque psoriasis, as measured by proportion of subjects showing at least 75% improvement in Psoriasis Area and Severity Index (PASI) 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] - Immune System Diseases [C20]
- Trial duration
- 2 Apr 2024 → 28 Aug 2025
- Decision date (initial)
- 2024-02-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Sun Pharmaceutical Industries Limited, India
External identifiers
- EU CT number
- 2023-506477-35-00
- WHO UTN
- U1111-1287-8390
- ClinicalTrials.gov
- NCT04566666
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Pharmacodynamic, Safety, Pharmacokinetic
To determine the effect of SCD-044 treatment on moderate to severe plaque psoriasis, as measured by proportion of subjects showing at least 75% improvement in Psoriasis Area and Severity Index (PASI) at Week 16.
Conditions and MedDRA coding
moderate to severe plaque psoriasis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10071117 | Plaque psoriasis | 10040785 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Males and non-pregnant non-lactating females ≥ 18 years of age providing written informed consent prior to any study-related procedures
- Diagnosis of predominantly plaque psoriasis for ≥ 6 months as determined by subject interview and confirmation of diagnosis through physical examination by Investigator
- Subject is a candidate for phototherapy or systemic therapy for plaque psoriasis.* *Note: Subjects are required to be candidates for systemic/phototherapy, however no such therapy will be allowed during the study. Please refer to exclusion criteria 3
- Moderate to severe plaque psoriasis at Screening and Baseline defined as: • BSA involvement of ≥ 10% • PASI score of ≥ 12 • IGA of at least moderate disease (≥ 3)
Exclusion criteria 2
- Predominantly non-plaque forms of psoriasis like erythrodermic psoriasis, pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new-onset guttate psoriasis
- History or presence of uveitis
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of subjects with at least 75% improvement in PASI (PASI75) at Week 16
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD10343136 · Product
- Active substance
- Vibozilimod
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0.1 mg milligram(s)
- Max total dose
- 36.4 mg milligram(s)
- Max treatment duration
- 52 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
- 109.2 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- L04AA — SELECTIVE IMMUNOSUPPRESSIVE AGENTS
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES
- Paediatric formulation
- No
- Orphan designation
- No
PRD10343127 · Product
- Active substance
- Vibozilimod
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 1.0 mg milligram(s)
- Max total dose
- 364 mg milligram(s)
- Max treatment duration
- 52 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
- 218.4 mg milligram(s)
- Max treatment duration
- 52 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 9
| Organisation | City, country | Duties |
|---|---|---|
| Acm Global Central Laboratory Limited ORG-100042459
|
York, United Kingdom | Laboratory analysis |
| Fisher Clinical Services GmbH ORG-100017323
|
Rheinfelden (Baden), Germany | Code 14 |
| Psi Cro AG ORG-100034251
|
Zug, Switzerland | On site monitoring, Code 12, Code 2, Code 5 |
| Canfield Scientific Inc. ORG-100042834
|
Parsippany, United States | Other |
| Sun Pharmaceutical Industries (Europe) B.V. ORG-100001121
|
Hoofddorp, Netherlands | Other |
| Trialogics LLC ORG-100047835
|
Wilmington, United States | Interactive response technologies (IRT) |
| Veranex ORL-000002727
|
Bangalore, India | Data management, E-data capture |
| Syneos Health Clinique Inc. ORG-100028348
|
Quebec, Canada | Laboratory analysis |
| Biostudy Solutions, LLC ORL-000002794
|
United States | Code 10 |
Locations
2 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Estonia | Ended | 14 | 2 |
| Poland | Ended | 49 | 10 |
| Rest of world
Georgia, El Salvador, United States
|
— | 177 | — |
Investigational sites
North Estonia Medical Centre Foundation
Dermatovenerology Centre, J. Sutiste Tee 19, Mustamae Linnaosa, Tallinn
Kliiniliste Uuringute Keskus OÜ
N/A, Sobra Tn 54/1, 50106, Tartu Linn
Specjalistyczne Gabinety Lekarskie 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
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Twoja Przychodnia SCM, Al. Wyzwolenia 46/16u, 71-500, Szczecin
EMC Instytut Medyczny S.A.
Prywatna Lecznica “Certus” Szpital Nr 1, Ul. Grunwaldzka 156, 60-309, Poznan
Clinicmed Daniluk Nowak Sp. k.
Clinicmed Daniluk Nowak Sp. k., Ul. Stoleczna 7/200, 15-879, Bialystok
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
Globe Badania Kliniczne Sp. z o.o.
GLOBE Clinical Research, Ul. Janusza Kusocinskiego 3a, 57-300, Klodzko
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Klinika Dermatologii, Ul. Woloska 137, 02-507, Warsaw
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Oddział Dermatologii i Wenerologii, Ul. Stanislawa Staszica 11, 20-081, Lublin
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 | 2024-04-19 | 2025-08-25 | 2024-04-22 | 2024-07-29 | |
| Poland | 2024-04-02 | 2025-08-27 | 2024-04-10 | 2024-07-31 |
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-125575
|
2026-03-26T11:38:07 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay Person Summary of Results_Estonian | 2026-03-26T11:39:29 | Submitted | Laypersons Summary of Results |
| Lay Person Summary of Results_Polish | 2026-03-26T11:39:05 | Submitted | Laypersons Summary of Results |
| Lay Person Summary of Results_Russian | 2026-03-26T11:38:39 | Submitted | Laypersons Summary of Results |
| Lay Person Summary of Results_English | 2026-03-26T11:39:58 | Submitted | Laypersons Summary of Results |
Documents 17 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_Dermatology Life Quality Index_Redacted | N/A |
| Protocol (for publication) | D1_Health Assessment Questionnaire of disability_Redacted | 1.0 |
| Protocol (for publication) | D1_Itch Numeric Rating Scale_Redacted | 4.1 |
| Protocol (for publication) | D1_Patient Assessment of Pain_Redacted | N/A |
| Protocol (for publication) | D1_Patient Global Assessment of Disease Activity_Redacted | N/A |
| Protocol (for publication) | D1_Patient Global Impression of Change_Redacted | N/A |
| Protocol (for publication) | D1_Patient Global Impression of Severity_Redacted | N/A |
| Protocol (for publication) | D1_Protocol_2023-506477-35-00_Redacted | 4.2 |
| Protocol (for publication) | D1_Psoriasis Symptoms and Signs diary_Redacted | 1.0 |
| Protocol (for publication) | D1_Scalp Itch Numeric Rating Scale_Redacted | N/A |
| Summary of results (for publication) | Summary of Results_Redacted | N/A |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_Layperson_2023-506477-35-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Laypersons_v_1_0_2023-506477-35-00 | 1.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-27 | Poland | Acceptable 2024-01-29
|
2024-02-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-22 | Poland | Acceptable | 2024-06-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-28 | Acceptable | 2024-05-08 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-23 | Poland | Acceptable | 2024-10-23 |