Phase 3 Psoriasis Trial, Completed NCT02207244 Sponsor: Janssen Research & Development, LLC Condition: Psoriasis
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Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial (NCT02207244) enrolled 992 adults with psoriasis across its first phase, split into three groups: 248 received a placebo (an inactive treatment), 496 received guselkumab (100 mg), and 248 received adalimumab (an existing treatment). The trial ran in several stages over a number of years, with some participants switching treatments or continuing into longer follow-up phases. The trial was primarily measuring skin improvement at 16 weeks, using two scoring tools: the Investigator's Global Assessment (IGA), where a doctor rates how clear the skin looks on a scale from 0 (fully cleared) to 4 (severe); and the PASI 90, which measures whether a participant's psoriasis severity score improved by at least 90% from where it started. The reported data shows that at 16 weeks, 84.1% of participants in the guselkumab group reached an IGA score of 0 or 1 (cleared or nearly cleared), compared with 8.5% in the placebo group. For the PASI 90 measure at 16 weeks, 70.0% of the guselkumab group met that threshold, compared with 2.4% in the placebo group. The reported data also shows secondary results comparing guselkumab and adalimumab at 24 weeks: 83.5% of the guselkumab group reached an IGA score of 0 or 1, compared with 64.9% for adalimumab; and 75.2% of the guselkumab group reached PASI 90, compared with 54.8% for adalimumab. A further secondary measure reported that 51.8% of the guselkumab group achieved fully cleared skin (IGA score of 0) at week 24, versus 31.5% in the adalimumab group. The reported data also includes a longer-term result looking at whether participants who had responded well to guselkumab could maintain that improvement after treatment was stopped. Among those whose treatment was withdrawn, 35.4% maintained a PASI 90 response through to week 48, compared with 81.8% of those who continued on guselkumab. Data for any outcomes not listed here were not reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Psoriasis Trial, Completed

NCT02207244
Completed 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:

  • You have been diagnosed with plaque-type psoriasis (with or without psoriatic arthritis) for at least 6 months before the start of the study
  • Your psoriasis is rated as moderately severe or worse based on a standard medical scoring system called PASI (confirm with trial site)
  • Your psoriasis is rated at least a 3 out of 5 by a doctor using a standard overall assessment scale (confirm with trial site)
  • At least 10% of your body surface area is affected by psoriasis
  • You are a suitable candidate for either full-body treatment with light therapy or medication that works throughout your whole body

Who may not be able to join:

  • You have a type of psoriasis other than plaque psoriasis, such as the widespread red skin type, the drop-shaped type, or the pus-filled type
  • Your psoriasis was caused or made worse by a medication such as beta blockers, calcium channel blockers, or lithium
  • You have ever previously been treated with the drugs guselkumab or adalimumab
  • You have a history of, or currently have, serious or uncontrolled problems affecting your kidneys, liver, heart, blood vessels, lungs, stomach or bowels, hormones, nerves, blood, joints, mental health, or metabolism
  • The trial doctor believes, for any reason, that joining the trial would not be in your best interest
  • You are pregnant, breastfeeding, or planning to become pregnant within 5 months of your last dose of the study drug (this applies to both men and women)

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 23 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

Australian sites

, Benowa,
, Hectorville,
, Melbourne,
, Parkville,
, Westmead,
, Woolloongabba,

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
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
3 November 2014
Est. completion
1 October 2015

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇨🇿 Czechia 🇩🇪 Germany 🇵🇱 Poland 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇺🇸 United States

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

Primary endpoints

Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16; Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group 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: 23 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