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NCT03881059 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)

A Phase 2 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 2
Development phase
203
Enrollment target

NCT03881059: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.

NCT03881059 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 203 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03881059, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
203 participants
Enrollment target

Study Summary

The main purpose of study is to assess the dose-response relationship of BMS-986165 (Dose A or Dose B once daily \[QD\]) at Week 16 in the treatment of participants with active PsA.

Primary Outcome

A participant is considered an ACR 20 responder if the following three conditions are met: 1) ≥ 20% improvement from baseline in the number of tender joints (68 joint count). 2) ≥ 20% improvement from baseline in the number of swollen joints (66 joint count). 3) ≥ 20% improvement from baseline in at least 3 of the following 5 domains: o Subject Global Assessment of disease activity o Physician Global Assessment of psoriatic arthritis o Subject Global Assessment of pain o Health Assessment Questi

Interventions

  • DRUG Ustekinumab
  • OTHER BMS-986165 Placebo
  • DRUG BMS-986165 Dose A
  • DRUG BMS-986165 Dose B
  • OTHER Ustekinumab Placebo

Trial Details

FieldValue
Enrollment Target 203 participants
Start Date 2019-04-01
Est. Completion 2021-01-27
Phase Phase 2
Bristol-Myers Squibb

1,025 total trials

What the finished NCT03881059 record still lists

NCT03881059 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher).

The record links to 0 conditions, and to 5 interventions - of which Ustekinumab is the first listed.

NCT03881059 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03881059 about?

NCT03881059 is a clinical study titled "Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)". The main purpose of study is to assess the dose-response relationship of BMS-986165 (Dose A or Dose B once daily \[QD\]) at Week 16 in the treatment of participants with active PsA.

What is the current status of trial NCT03881059?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 203 participants. The study started on 2019-04-01. Estimated completion is 2021-01-27.

What interventions are being tested in trial NCT03881059?

The interventions under investigation include: Ustekinumab (DRUG), BMS-986165 Placebo (OTHER), BMS-986165 Dose A (DRUG), BMS-986165 Dose B (DRUG), Ustekinumab Placebo (OTHER).

Who is sponsoring clinical trial NCT03881059?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03881059's enrollment target sits among peer trials

203 301st of 2000 higher than 1,700 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03881059, the US trial registry maintained by the National Library of Medicine. NCT03881059 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.