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ACTIVE NOT RECRUITING Phase 3

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

NCT04036435 · View on ClinicalTrials.gov ↗

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

504 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04036435

The ClinicalTrials.gov registry entry for NCT04036435 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,466 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04036435 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04036435?

The interventions under investigation include: Placebo (DRUG), BMS-986165 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04036435?

This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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