Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
828
Countries
1
Sites
6
Moderate to Severe Plaque Type Psoriasis
The primary objective of the study is to demonstrate that Super- Responders maintain control of disease until week 68 with prolonged treatment intervals of 16 weeks (100 mg q16w).
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 11 Feb 2019 → 7 Jan 2025
- Decision date (initial)
- 2024-06-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508424-34-00
- EudraCT number
- 2018-001238-16
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Therapy, Efficacy, Pharmacogenetic
The primary objective of the study is to demonstrate that Super- Responders maintain control of disease until week 68 with prolonged treatment intervals of 16 weeks (100 mg q16w).
Conditions and MedDRA coding
Moderate to Severe Plaque Type Psoriasis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10037153 | Psoriasis | 100000004858 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Male or female with at least 18 years of age.
- 2. Has a disease duration of plaque psoriasis of either ≤2 years or >2 years calculated from date at which first symptoms [plaque] were reported by subject to date of screening visit at screening; approximately 40% subjects must have a disease duration ≤2 years.
- 3. Has moderate-to-severe plaque-psoriasis defined by a) a PASI score >10 or affected BSA >10% and b) a DLQI score >10 at baseline (week 0).
- 4. Is a candidate for systemic treatment for psoriasis.
- 5. Before first administration of study drug, a woman must be: a. Not of childbearing potential b. Of childbearing potential and practicing a highly effective method of contraception
Exclusion criteria 5
- 1. clinical active psoriasis arthritis which needs systemic therapy beyond NSAIDs
- 2. diagnosed or reported history or current signs or symptoms indicating severe, progressive, or uncontrolled hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, which are detected at screening assessments
- 3. unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months, diagnosed or reported by the subject
- 4. Has a transplanted organ
- 5. history of an infected joint prosthesis or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint of the main study is the proportion of subjects in study groups 2a and 2b who achieve an absolute PASI score <3 at week 68.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL
PRD2827309 · Product
- Active substance
- Guselkumab
- Pharmaceutical form
- INJECTION/INFUSION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
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
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 4
| Organisation | City, country | Duties |
|---|---|---|
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Interactive response technologies (IRT) |
| Tata Consultancy Services Limited ORG-100044792
|
Mumbai, India | Data management |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| aCROmion GmbH ORG-100031978
|
Frechen, Germany | Code 10, Code 11, Data management, E-data capture |
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 828 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Tuebingen AöR
Dermatologie, Liebermeisterstrasse 25, Innenstadt, Tuebingen
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
NA, Am Bahnhof 1, Mahlow, Blankenfelde-Mahlow
MVZ Corius Potsdam GmbH
NA, Berliner Strasse 131, Berliner Vorstadt, Potsdam
ISA Interdisciplinary Study Association GmbH
NA, Rankestrasse 33/34, Charlottenburg, Berlin
Goethe University Frankfurt
Klinik für Dermatologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Hautarztpraxis Dr Med Matthias Hoffmann
NA, Annenstrasse 151, 58453, Witten
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 |
|---|---|---|---|---|---|
| Germany | 2019-02-11 | 2025-01-07 | 2019-02-18 | 2020-11-30 |
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 |
|---|---|---|---|
| 2023-508424-34-00 (CNTO1959PSO3012)- Summary of results- Final SUM-113412
|
2026-01-05T17:20:21 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| CNTO1959PSO3012_PLS_Final_25 November 2025_DEU_German | 2026-01-05T17:20:52 | Submitted | Laypersons Summary of Results |
| CNTO1959PSO3012_PLS_Final_25 November 2025_FRA_French | 2026-01-05T17:20:41 | 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) | CNTO1959PSO3012_PLS_Final_25 November 2025_DEU_German | 1 |
| Laypersons summary of results (for publication) | CNTO1959PSO3012_PLS_Final_25 November 2025_FRA_French | 1 |
| Protocol (for publication) | REDACTED_D1_Protocol_2023-508424-34 | Am6 |
| Protocol (for publication) | REDACTED_D4_PF_DLQI_DE_GER_2023-508424-34 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_NAPPA QOL PBI adapted_DE_GER_2023-508424-34 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_PSSD 7day_DE_GER_2023-508424-34 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER_K1_Recruitment Arrangements_DE_ENG_2023-508424-34 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Country-specific Main_ICF_Addendum 6_DE_GER_2023-508424-34 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Genetic_DE_GER_2023-508424-34 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Addendum 4_DE_GER_2023-508424-34 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Addendum 5_DE_GER_2023-508424-34 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_DE_GER_2023-508424-34 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Opt Sample Addendum 2_DE_GER_2023-508424-34 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Opt Sample_DE_GER_2023-508424-34 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant partner_DE_GER_2023-508424-34 | 1 |
| Subject information and informed consent form (for publication) | Redacted_L2_Subject Wallet Card_DE_GER_2023-508424-34 | 3 |
| Summary of results (for publication) | 2023-508424-34-00 - CNTO1959PSO3012- Summary of results- Final | 27.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-22 | Germany | Acceptable 2024-05-31
|
2024-06-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-28 | Germany | Acceptable 2024-11-21
|
2024-12-04 |