Velocity: A Study of JNJ-81241459 in Participants With Moderate to Severe Plaque Psoriasis

• Research type

  Research Study

• Full 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.

• IRAS ID

  1009563

• Contact name

  David Wright

• Contact email

  GCOUKSubmissions@its.jnj.com

• Sponsor organisation

  Janssen-Cilag International N.V.

• Eudract number

  2023-508992-35

• ISRCTN Number

  ISRCTN76294777

• Research summary

  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. (*A specific type of protein involved in inflammation. **a protein that binds to specific molecule).
  The study drug, JNJ- 81241459, is a medicine designed to inhibit the IL-17 binding to its receptor.
  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.
  Study includes participants of 18 years or older with moderate to severe plaque psoriasis.
  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.

  Summary of results
  The study was cancelled prior to any site opening globally. There are no study results

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  24/EM/0100

• Date of REC Opinion

  30 May 2024

• REC opinion

  Further Information Favourable Opinion