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NCT04036435 · ClinicalTrials.gov registry record · Phase 3

Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis

A Phase 3 study of Psoriasis, sponsored by Bristol-Myers Squibb.

Active
Registry status
Phase 3
Development phase
1,466
Enrollment target
20
Study locations

NCT04036435 is a Phase 3 study of Psoriasis that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 1,466 participants, above the 477-participant average among 125 other Psoriasis trials with a reported enrollment target (207% higher). The trial reports 20 study locations across 4 states.

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The verdict

NCT04036435, a Phase 3 study of Psoriasis, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,466 participants
Enrollment target
20
Study locations

Study Summary

The main purpose of this study is to evaluate the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in participants who have been previously enrolled in an applicable Phase 3 psoriasis study. In addition, the study includes a vaccine cohort to evaluate whether deucravacitinib impacts the humoral immune response to 2 non-live vaccines, the Pneumovax 23 vaccine (pneumococcus), a T-cell independent vaccine, and the Boostrix vaccine (tetanus toxoid), a T-cell dependent vaccine. Additionally, this vaccine cohort assesses the safety of administering these vaccines to subjects with psoriasis receiving deucravacitinib compared to those receiving a placebo.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG BMS-986165

Study Locations (20)

California

  • Local Institution - 0046 - Fountain Valley
  • Local Institution - 0206 - Fresno
  • Local Institution - 0017 - Irvine
  • Interspond - Long Beach Clinical Trials - Long Beach
  • Dermatology Research Associates - Los Angeles - Los Angeles
  • Local Institution - 0236 - Los Angeles
  • University of California San Diego Health Systems - San Diego
  • Therapeutics Clinical Research - San Diego
  • University Dermatology Group - San Diego
  • Local Institution - 0094 - San Luis Obispo
  • Clinical Science Institute - Santa Monica
  • NorthBay Clinical Research - Santa Rosa

Arizona

  • Alliance Dermatology and Mohs Center - Phoenix - Phoenix
  • Arizona Research Center - Phoenix
  • Synexus - Orange Grove Family Practice - Tucson

Arkansas

  • Johnson Dermatology - Fort Smith
  • Burke Pharmaceutical Research - Hot Springs
  • Northwest Arkansas Clinical Trials Center, PLLC - Rogers

Alabama

  • Total Skin and Beauty Dermatology Center - Birmingham
  • Local Institution - 0278 - Birmingham

Trial Details

FieldValue
Enrollment Target 1,466 participants
Start Date 2019-08-12
Est. Completion 2026-07-26
Phase Phase 3

Sponsor

Bristol-Myers Squibb

1,025 total trials

What the Registry Record Tells You About NCT04036435

The ClinicalTrials.gov registry entry for NCT04036435 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,466 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 477-participant average among 125 other Psoriasis trials with a reported enrollment target (207% higher). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Psoriasis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04036435 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Arkansas.

Frequently Asked Questions

What is clinical trial NCT04036435 about?

NCT04036435 is a clinical study titled "Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis". The main purpose of this study is to evaluate the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in participants who have been previously enrolled in an applicable Phase 3 psoriasis study. In addition, the study includes a vaccine cohort to evaluate whether deucravacitinib im...

What is the current status of trial NCT04036435?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,466 participants. The study started on 2019-08-12. Estimated completion is 2026-07-26.

What conditions does trial NCT04036435 study?

This clinical trial studies the following conditions: Psoriasis.

What interventions are being tested in trial NCT04036435?

The interventions under investigation include: Placebo (DRUG), BMS-986165 (DRUG).

Who is sponsoring clinical trial NCT04036435?

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

Where is trial NCT04036435 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.