Phase 3 Psoriatic Arthritis Trial, Recruiting NCT06807424 Sponsor: Janssen Research & Development, LLC Condition: Psoriatic Arthritis
Back to Psoriatic Arthritis

Phase 3 Psoriatic Arthritis Trial, Recruiting

NCT06807424
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have active psoriatic arthritis (PsA) that has not been fully controlled despite having tried at least one of the following: a non-biologic DMARD medication, apremilast, or one biologic medication
  • People who have had a confirmed diagnosis of PsA for at least 3 months before the first study treatment, and whose condition meets a recognised set of classification criteria for PsA (called CASPAR criteria) at the screening visit
  • People who have active PsA at both the screening and baseline visits, meaning at least 3 swollen joints and at least 3 tender joints, plus a blood marker of inflammation (CRP) at or above a certain level on a central lab test
  • People whose PsA falls into at least one of these subtypes: involvement of the small joints at the tips of the fingers or toes, arthritis affecting many joints without rheumatoid nodules, a severe destructive form of arthritis (arthritis mutilans), arthritis affecting joints unevenly on the body, or spinal inflammation combined with joint involvement
  • People who have active plaque psoriasis with at least one skin plaque of 2 cm or more in size, or nail changes consistent with psoriasis
  • Female participants of childbearing potential must have a negative blood pregnancy test at screening and a negative urine pregnancy test before the first study treatment is given

Who may not be able to join:

  • People who have a history of, or currently have signs or symptoms of, serious or uncontrolled problems affecting the kidneys, liver, heart, blood vessels, lungs, gut, hormonal system, nervous system, blood, joints (other than PsA), mental health, urinary or reproductive system, or metabolism
  • People who currently have cancer, or who have had cancer at any point in the 5 years before the screening visit
  • People who have a known allergy, sensitivity, or intolerance to the study drug (icotrokinra) or any of its ingredients
  • People who have other inflammatory conditions that could make it difficult to assess how well the study treatment is working — for example, rheumatoid arthritis, lupus, or Lyme disease
  • People who have fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, could interfere with the ability to accurately measure the trial's effectiveness

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Phone: 844-434-4210

Australian sites

Ipswich Hospital, Ipswich,
Rheumatology Research Unit, Maroochydore,
Queen Elizabeth Hospital, South Woodville,
Royal North Shore Hospital, St Leonards,
Royal Darwin Hospital, Tiwi,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
9 January 2025
Est. completion
10 February 2027

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇩🇰 Denmark 🇩🇪 Germany Hong Kong 🇭🇺 Hungary 🇮🇳 India 🇮🇹 Italy 🇯🇵 Japan 🇲🇾 Malaysia 🇲🇽 Mexico 🇵🇱 Poland 🇷🇴 Romania 🇪🇸 Spain 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Proportion of Participants who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov