Phase 3 Psoriatic Arthritis Trial, Terminated NCT04115748 Sponsor: Gilead Sciences Condition: Psoriatic Arthritis
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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 (NCT04115748) enrolled 67 people across four groups during the main 16-week study: 19 received filgotinib 200 mg, 19 received filgotinib 100 mg, 9 received adalimumab 40 mg, and 20 received a placebo (a dummy treatment with no active ingredient). A smaller long-term extension then followed participants who completed the main study through to week 50, though none completed that extension phase. The trial was measuring various aspects of psoriatic arthritis disease activity, including joint tenderness and swelling, skin involvement, and participants' own assessments of pain and function. The reported data shows that for the main outcome — the proportion of participants whose joint and disease activity scores improved by at least 20% by week 12 — the figures were: 76.8% in the filgotinib 200 mg group, 63.2% in the filgotinib 100 mg group, 67.2% in the adalimumab group, and 44.8% in the placebo group. For the secondary measures, the reported data shows reductions over 16 weeks in several composite disease activity scores across all groups. For example, on one composite score (PASDAS, rated 0–10 where lower is better), average reductions of around 2.5 points were reported for filgotinib 200 mg and adalimumab, around 2.0 for filgotinib 100 mg, and around 1.0 for placebo. The proportion of participants reaching a "minimal disease activity" threshold by week 16 was reported as approximately 44% for filgotinib 200 mg, 47% for filgotinib 100 mg, 38% for adalimumab, and 16% for placebo. It is worth noting that this trial had a relatively small number of participants and a large proportion did not complete the main study phase, which the data does not fully explain. 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 Psoriatic Arthritis Trial, Terminated

NCT04115748
Terminated 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 Psoriatic Arthritis (PsA) that meets specific medical classification standards, and you have had this condition for at least 6 months before the screening visit
  • You have active joint inflammation, meaning at least 3 swollen joints and at least 3 tender/painful joints at both your screening visit and the start of the study
  • You have a documented history or currently visible signs of either skin psoriasis (raised, scaly patches) or nail changes caused by psoriasis
  • You have tried at least one standard arthritis medication (such as a conventional disease-modifying drug, apremilast, or an anti-inflammatory painkiller) for at least 12 weeks, but it either did not work well enough for you or you could not tolerate it

Who may not be able to join:

  • You have previously been treated for PsA or psoriasis with a type of medication called a "biologic" (a drug made from living cells, often given by injection or infusion)
  • You have previously taken more than 2 doses of a type of medication called a JAK inhibitor
  • You currently have an active infection or have had a recent infection
  • You have a long-term or poorly controlled health condition that the study doctor believes could put you at higher risk during the trial, or that might make it difficult for you to complete the study
  • You have a moderate to severe joint or skin condition other than PsA or plaque psoriasis that could affect how the study results are measured (confirm with trial site)
  • You have a history of inflammatory arthritis (joint inflammation disease) that started before you were 16 years old
  • You have an active autoimmune condition — such as eye inflammation (uveitis), inflammatory bowel disease, uncontrolled thyroid problems, or certain other immune system disorders — that could interfere with the study or put you at risk
  • You are currently pregnant or breastfeeding
  • You are currently misusing drugs or alcohol, as judged by the study doctor

⚠️ Important: Always verify eligibility with the trial site directly before applying. This summary is for general information only and does not constitute medical advice. Additional eligibility criteria not listed here may also apply.

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: Gilead Study Director, Gilead Sciences

Australian sites

Genesis Research Services, Broadmeadow, New South Wales
Rheumatology Research Unit, Maroochydore, Queensland
Emeritus Research, Camberwell, Victoria

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

GP referral letter

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Trial details

Status
Terminated
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
3 December 2019
Est. completion
19 January 2021

Where this trial is recruiting

🇦🇺 Australia 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇿 Czechia 🇭🇺 Hungary 🇯🇵 Japan 🇳🇿 New Zealand 🇵🇱 Poland 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

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

Primary endpoints

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement Response at Week 12

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