A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis

Part of paid clinical trials in Glendale, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06807424
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Arthritis, Psoriatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Icotrokinra — DRUG
    Icotrokinra will be administered.
  • Placebo — DRUG
    Placebo will be administered.

Study Details

The purpose of this study is to evaluate the efficacy of icotrokinra (JNJ-77242113) compared to placebo in biologic-experienced and biologic-naive participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Key Dates

Start date
Jan 9, 2025
Status verified
Jun 2026
Primary completion
Feb 10, 2027
Completion
Oct 18, 2028

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group I: Icotrokinra Dose 1
    Participants will receive icotrokinra Dose 1. Participants who have not discontinued will be eligible to enter a long term extension (LTE) and will continue to receive icotrokinra Dose 1.
  • Experimental: Group II: Icotrokinra Dose 2
    Participants will receive icotrokinra Dose 2. Participants who have not discontinued will be eligible to enter a LTE and will continue to receive icotrokinra Dose 2.
  • Placebo Comparator: Group III: Placebo
    Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra Dose 1 or Dose 2 at Week 16. Participants who have not discontinued will be eligible to enter a LTE and will continue to receive icotrokinra Dose 1 or Dose 2.

Primary Outcome Measure

Proportion of Participants who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16 [ Time Frame: Week 16 ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
AARA Clinical ResearchGlendaleArizona85306-
AARA Clinical Research 1MesaArizona85210-
Arthritis and Rheumatism Associates ARA JonesboroJonesboroArkansas72401-
Clinical Research of West FloridaClearwaterFlorida33765-
Omega Research ConsultantsDeBaryFlorida32713-
Suncoast Clinical ResearchNew Port RicheyFlorida34652-
Integral Rheumatology And Immunology SpecialistsPlantationFlorida33324-
Clinical Research of West Florida 1TampaFlorida33606-
Clinic of Robert HozmanSkokieIllinois60076-
Klein And Associates M D P AHagerstownMaryland21740-
DM Clinical Research 1BrooklineMassachusetts02446-
St Paul Rheumatology PAEaganMinnesota55123-
Albuquerque Rehabilitation and RheumatologyAlbuquerqueNew Mexico87102-
Joint and Muscle Research InstituteCharlotteNorth Carolina28204-
Rheumatology Associates of OklahomaOklahoma CityOklahoma73116-
Altoona Center For Clinical ResearchDuncansvillePennsylvania16635-
Arthritis and Rheumatology Research InstituteAllenTexas75013-
UT SouthwesternDallasTexas75390-
Naiara Alvarez MD Integrative Rheumatology of South TXHarlingenTexas78550-
AARA Clinical Research Lone Star Arthritis and RheumatologyIrvingTexas75039-
DM Clinical ResearchTomballTexas77375-
Velocity Clinical ResearchWacoTexas76710-
Seattle RheumatologySeattleWashington98104-

Find similar trials in Glendale, AZ

By research site
AARA Clinical Research· Glendale, AZAARA Clinical Research 1· Mesa, AZArthritis and Rheumatism Associates ARA Jonesboro· Jonesboro, ARClinical Research of West Florida· Clearwater, FLOmega Research Consultants· DeBary, FLSuncoast Clinical Research· New Port Richey, FL

Related Studies