A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis

ClinicalTrials.gov ID

NCT05730725

Acronym / sponsor ID

IM032-041

Conditions

Psoriasis

Keywords

Moderate-to-Severe Psoriasis, BMS-986322, TYK2 inhibitor

Phase

Phase 2

Study type

Interventional

Recruitment status

Completed

Enrolment

109 participants (actual)

Lead sponsor

Bristol-Myers SquibbIndustry (pharma, biotech, devices)

Study start

3 Apr 2023 (actual)

Primary completion

6 Aug 2024 (actual)

Study completion

6 Aug 2024 (actual)

First posted

16 Feb 2023 (actual)

Results

Posted 25 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Quadruple blind (participant, care provider, investigator, outcomes assessor)

Number of arms

4

Who may qualify

Ages

18 to 70 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Percentage of Participants Achiving PASI-75 at Week 12

   Time frame: 12 Weeks

   PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI-75 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 75% reduction from baseline in PASI score. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.

2. Number of Participants With Safety Related Events

   Time frame: approximately 85 days

   Treatment related adverse events, serious adverse events and treatment related adverse events leading to treatment discontinuation are considered safety related events.

3. Number of Participants With TEAE by Worst Intensity

   Time frame: approximately 5 months

   Mild TEAE: An event that is easily tolerated by the participant, causing minimal discomfort, and not interfering with everyday activities. Moderate TEAE:An event that causes sufficient discomfort and interferes with normal everyday activities. Severe TEAE: An event that prevents normal everyday activities. An AE that is assessed as severe should not be confused with an SAE. Severe is a category utilized for rating the intensity of an event, and both AEs and SAEs can be assessed as severe.

4. Number of Participants With AE Indicating Clinical Laboratory Abnormality

   Time frame: approximately 5 months

   Number of participants with AE indicating clinical laboratory abnormality

5. Number of Participants With Clinically Significant Changes From Baseline in ECG Evaluations.

   Time frame: approximately 5 months

   Number of participants with clinically significant changes from baseline in ECG evaluations. ECG results for participants with any result outside of a pre-specified range and investigator identified abnormalities will be listed for the Safety Population. The following criteria will be used to determine ECG results that are outside of a pre-specified range: * PR (msec): Value > 200 * QRS (msec): Value > 120 * QT (msec): Value > 500 or change from baseline > 30 * QTcF (msec): Value > 450 or change from baseline > 30

6. Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Evaluations

   Time frame: approximately 5 months

   Number of participants with clinically significant changes from baseline in vital signs evaluations. Vital signs for participants with any out-of-range result will be listed for the Safety Population. The following criteria will be used to determine vital sign results that are outside of a prespecified range, where changes from baseline are based on matched postural positions: * Heart Rate (bpm): Value > 100 and change from baseline > 30, or Value < 55 and change from baseline < -15 * Systolic blood pressure (mmHg): Value > 140 and change from baseline > 20, or Value < 90 and change from baseline < -20 * Diastolic blood pressure (mmHg): Value > 90 and change from baseline > 10, or Value < 55 and change from baseline < -10 * Respiration (breaths/min): Value > 16 or change from baseline > 10 * Temperature (°C): Value > 38.3 or change from baseline > 1.6

7. Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Evaluations

   Time frame: approximately 5 months

   Number of participants with clinically significant changes from baseline in physical examination evaluations

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• BMS Clinical Trial InformationLink provided by the sponsor.
• BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
• Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trialsand research/disclosurecommitment.html

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

35 sites in 5 countries: see every site and its status.