FRONTIER 1: Efficacy and Safety of JNJ-77242113 in Moderate to Severe Plaque Psoriasis
Research type
Research Study
Full title
A Phase 2b Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis.
IRAS ID
1004415
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2021-003700-41
ISRCTN Number
ISRCTN76915275
Clinicaltrials.gov Identifier
Research summary
This is a research study in 240 adults with Moderate-to-Severe Plaque Psoriasis.
Plaque psoriasis is a common, chronic, inflammatory condition, affecting approximately 3.5 million patients in the United States, European Union, and Japan. Despite several advanced treatment options, a large proportion of patients are not receiving these therapies and there is a need for safer options, fewer injections, and options for oral medication.
The investigational drug is called JNJ-77242113. It is a first in class oral compound that is designed to block the binding of interleukin 23 (IL-23) to its receptor. It is hoped that blocking this process will inhibit downstream effects such as the release of inflammatory chemicals called cytokines and may lead to less inflammation and a reduction in Psoriasis disease activity. This study is designed to see if JNJ-77242113 is better than placebo in reducing Psoriasis disease activity disease.
This study will last for a maximum of 24 weeks and is divided into 3 parts:
1. Screening Phase: 1 visit (up to 4 weeks)
2. Treatment Phase: 7 visits (16 weeks)
3.a. Safety Follow-Up Phase: 1 visit (4 weeks) - for participants who do not enter the LTE study
OR
3.b. Long-Term Extension (LTE) Phase: (36 weeks) - for participants who enter the LTE study
During study visits a variety of tests will be carried out including, but not limited to, BP, ECG, physical exam, questionnaires and blood samples. Patients will be randomly assigned to receive either oral JNJ-77242113 at one of 5 different dosing regimens, or Placebo daily during the treatment phase. At the end of this phase, participants who do not enter the LTE study will complete a final safety follow up visit. Participants who enroll into the LTE study, will receive active JNJ-77242113 for 36 weeks.REC name
London - Westminster Research Ethics Committee
REC reference
22/LO/0125
Date of REC Opinion
30 Mar 2022
REC opinion
Further Information Favourable Opinion