Velocity: A study of JNJ-81241459 in participants with moderate to severe plaque psoriasis
| ISRCTN | ISRCTN76294777 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76294777 |
| EudraCT/CTIS number | 2023-508992-35 |
| IRAS number | 1009563 |
| Secondary identifying numbers | 81241459PSO2001, IRAS 1009563, CPMS 59821 |
- Submission date
- 12/04/2024
- Registration date
- 06/06/2024
- Last edited
- 23/07/2024
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Plaque psoriasis is skin disease that causes dry, itchy, thick, and raised skin patches on skin. Drugs that prevent interleukin (IL)-17 or 23* from binding to its receptor** may be an effective way to disease control.
The study drug, JNJ- 81241459, is a medicine designed to inhibit the IL-17 binding to its receptor.
*A specific type of protein involved in inflammation.
**a protein that binds to specific molecule
The purpose of this study is to see how effective JNJ-81241459 is when compared to placebo (looks like JNJ-81241459 but it does not contain any active medication) in participants with moderate to severe plaque psoriasis.
Who can participate?
Study includes participants of 18 years or older with moderate to severe plaque psoriasis.
What does the study involve?
Study will be conducted in 3 periods:
1. Screening period (5 weeks)
2. Double-blind 12 weeks) treatment period: Participants will be randomly (like flip of a coin) divided into 5 groups (1:1:1:1:1) to receive JNJ-81241459 or placebo from Week 0 through Week 12.
• Group 1: Participants will receive JNJ-81241459 Dose 1.
• Group 2: Participants will receive JNJ-81241459 Dose 2.
• Group 3: Participants will receive JNJ-81241459 Dose 3.
• Group 4: Participants will receive JNJ-81241459 Dose 4.
• Group 5: Participants will receive JNJ-81241459 matching placebo.
3. Follow-up period (4 weeks): Participants will be monitored for their health after the last dose of study drug until the study ends.
All side effects will be recorded until study ends. The total study duration is approximately 6 months. Participants will undergo study assessments and tests, such as questionnaires, blood tests, vital signs, and physical exams. The possible side effects of the study drug will be recorded till end of the study. Blood samples will be taken at multiple timepoints to understand how the
body responds to study drug.
What are the possible benefits and risks of participating?
There is no established benefit to participants of this study. Based on scientific theory, taking JNJ- 81241459 may reduce plaque psoriasis (red, scaly, itchy patches on the skin). However, this cannot be guaranteed because JNJ-81241459 is still under investigation as a treatment and it is not known whether JNJ-81241459 will work.
If participants are put into the placebo treatment group, they will not receive JNJ-81241459 and will only receive placebo during this study.
Participants may experience some benefit from participation in the study that is not due to receiving JNJ-81241459, but due to regular visits and assessments monitoring overall health. Participation may help other people with plaque psoriasis in the future.
Participants may have side effects from the drugs or procedures used in this study that may be mild to severe and even life-threatening, and they can vary from person to person. Potential risks include hypersensitivity reactions, anti-drug antibody production, infection, malignancy, inflammatory bowel disease, suicidal ideation and behavior, cytopenia, reproductive risk and pregnancy, QTc Interval Prolongation, tablet size and swallowing difficulty/airway obstruction.
Skin biopsy (optional procedure) may cause mild bleeding, pain, discomfort, scarring, discoloration, and infection.
The participant information sheet and informed consent form, which will be signed by every participant agreeing to participate in the study, includes a detailed section outlining the known risks to participating in the study.
Not all possible side effects related to JNJ-81241459 are known at this moment. During the study, the sponsor may learn new information about JNJ-81241459. The study doctor will tell participants as soon as possible about any new information that might make them change their mind about being in the study, such as new risks.
To minimize the risk associated with taking part in the study, participants are frequently reviewed for any side effects and other medical events. Participants are educated to report any such events to the study doctor who will provide appropriate medical care. Any serious side effects that are reported to the sponsor are thoroughly reviewed by a specialist drug safety team.
There are no costs to participants to be in the study. The sponsor will pay for the study drug and tests that are part of the study. The participant will receive reasonable reimbursement for study related
costs (e.g., travel/parking costs).
Where is the study run from?
Janssen-Cilag International NV (Netherlands)
When is the study starting and how long is it expected to run for?
November 2023 to June 2025
Who is funding the study?
Janssen Research and Development LLC (USA)
Who is the main contact?
medinfo@its.jnj.com
Contact information
Scientific
50-100 Holmers Farm Way
High Wycombe
HP12 4DP
United Kingdom
| Phone | +44 800 731 8450 / +1 494 567 444 |
|---|---|
| medinfo@its.jnj.com |
Principal Investigator
Stott Lane
Salford
M6 8HD
United Kingdom
Study information
| Study design | Interventional double blind randomized placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | A phase 2b multicenter, randomized, double-blind, placebo-controlled dose-ranging study to evaluate the efficacy and safety of JNJ-81241459 for the treatment of participants with moderate to severe plaque psoriasis |
| Study acronym | Velocity |
| Study hypothesis | Primary objective: To evaluate how effective is the JNJ-81241459 when compared with placebo in participants with moderate to severe plaque psoriasis. Secondary objectives: 1. To further evaluate how effective is the JNJ-81241459 when compared with placebo in participants with moderate to severe plaque psoriasis. 2. To evaluate the effect of JNJ-81241459 compared with placebo on patient reported outcomes in participants with moderate to severe plaque psoriasis. 3. To evaluate the safety and tolerability of JNJ-81241459 compared with placebo in participants with moderate to severe plaque psoriasis. |
| Ethics approval(s) |
Approved 30/05/2024, East Midlands – Derby (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8154; derby.rec@hra.nhs.uk), ref: 24/EM/0100 |
| Condition | Plaque Psoriasis |
| Intervention | Study will be conducted in 3 periods: 1. Screening period (5 weeks) 2. Double-blind 12 weeks) treatment period: Participants will be randomly (like flip of a coin) divided into 5 groups (1:1:1:1:1) to receive JNJ-81241459 or placebo from Week 0 through Week 12. • Group 1: Participants will receive JNJ-81241459 Dose 1. • Group 2: Participants will receive JNJ-81241459 Dose 2. • Group 3: Participants will receive JNJ-81241459 Dose 3. • Group 4: Participants will receive JNJ-81241459 Dose 4. • Group 5: Participants will receive JNJ-81241459 matching placebo. 3. Follow-up period (4 weeks): Participants will be monitored for their health after the last dose of study drug until the study ends. All side effects will be recorded until study ends. The total study duration is approximately 6 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacokinetic, Pharmacodynamic, Dose response, Pharmacogenetic, Pharmacogenomic |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | JNJ-81241459 |
| Primary outcome measure | 1. Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 12 |
| Secondary outcome measures | 1. Percentage of Participants Achieving PASI 90 at Week 12 2. Percentage of Participants Achieving PASI 100 at Week 12 3. Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and a Greater Than or Equal to [>=] 2 Grade Improvement From Baseline at Week 12 4. Percentage of Participants Achieving an IGA score of cleared (0) at Week 12 5. Change from Baseline in Body Surface Area (BSA) at Week 12 6. Change from baseline in PASI total score at Week 12 7. Percent Change from Baseline in PASI Total Score at Week 12 8. Percentage of Participants Achieving Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Score=0 at Week 12 9. Percentage of Participants Achieving PSSD sign score of 0 at Week 12 10. Percentage of Participants Achieving ≥4-point improvement from baseline in PSSD Itch score at Week 12 11. Change from baseline in PSSD symptom score at Week 12 12. Change from baseline in PSSD sign score at Week 12 13. Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 12 14. Change from baseline DLQI total score at Week 12 15. Number of Participants with Adverse Events (AEs) 16. Number of Participants with Serious Adverse Events (SAEs) |
| Overall study start date | 20/11/2023 |
| Overall study end date | 02/06/2025 |
| Reason abandoned (if study stopped) | Non-clinical findings |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Participant inclusion criteria | 1. Be ≥18 years of age at screening, inclusive 2. Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention 3. Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline 4. Total Psoriasis area and severity index (PASI) >=12 at screening and baseline 5. Total Investigator global assessment (IGA) >=3 at screening and baseline 6. Candidate for phototherapy or systemic treatment for plaque Psoriasis |
| Participant exclusion criteria | 1. Nonplaque form of psoriasis (eg, erythrodermic, guttate, or pustular) 2. Current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) 3. Known allergies, hypersensitivity, or intolerance to JNJ-81241459 or its excipients (refer to the JNJ-81241459 IB) 4. Previously received JNJ-81241459 5. Experienced primary efficacy failure (no response within 12 weeks) or a clinical adverse event related to agents directly targeting interleukin 17 receptor (IL-17) |
| Recruitment start date | 01/09/2024 |
| Recruitment end date | 13/01/2025 |
Locations
Countries of recruitment
- Canada
- France
- Germany
- Japan
- Poland
- Spain
- United Kingdom
Study participating centres
Leytonstone
London
E11 1NR
United Kingdom
Corby
NN17 2UR
United Kingdom
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Desborough Road
High Wycombe
HP11 2QW
United Kingdom
Gayton Road
King's Lynn
PE30 4ET
United Kingdom
North Finchley
London
N12 8BU
United Kingdom
Salford
M6 8HD
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor information
Industry
Janssen Biologics BV - Clinical Registry Group - Archimedesweg 29
Leiden
2333 CM
Netherlands
| ClinicalTrialsEU@its.jnj.com |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Janssen R&D, Janssen Research & Development, Janssen Research & Development, LLC, Janssen Research & Development LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Research & Development at Janssen, JRD, J&J PRD
- Location
- United States of America
Results and Publications
| Intention to publish date | 17/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Peer reviewed scientific journals Internal report Conference presentation Submission to regulatory authorities Results of the study will be available to the wider scientific community via publication in scientific journals and presentation at scientific meetings. Study results will be available to participants via provision of a Plain Language Summary at the end of the study and in addition results will be published in the EudraCT database. |
| IPD sharing plan | The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu |
Editorial Notes
23/07/2024: The study was stopped prior to any site activation.
02/07/2024: Internal review.
12/04/2024: Trial's existence confirmed by NHS HRA.
