BMS-986322 for Psoriasis

Recruiting at 72 trial locations

Overseen By First line of the email MUST contain NCT # and Site #.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bristol-Myers Squibb

Must not be taking: Systemic immunosuppressants

Disqualifiers: Non-plaque psoriasis, Uveitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

109 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called BMS-986322 to see if it can help people with moderate-to-severe psoriasis by reducing inflammation and slowing down skin cell growth.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressant treatment for conditions like uveitis or inflammatory bowel disease, you may not be eligible to participate.

What data supports the effectiveness of the drug BMS-986322 for treating psoriasis?

Research on similar treatments, like apremilast, shows that it can significantly improve psoriasis symptoms and quality of life. Apremilast, a drug used for moderate-to-severe psoriasis, has been effective in reducing psoriasis severity and improving patient satisfaction. ^{1 2 3 4 5}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults who've had plaque psoriasis for at least 6 months, with a moderate to severe level of disease. They should be eligible for phototherapy or systemic therapy and have plaques covering 10% or more of their body. People with certain other immune conditions, significant illnesses, or non-plaque forms of psoriasis cannot join.

Inclusion Criteria

My psoriasis covers 10% or more of my body.

My doctor thinks I am a good candidate for light or systemic therapy.

My BMI is between 18 and 40, and I weigh more than 50 kg (110 lbs).

Exclusion Criteria

I have a serious long-term or recent illness.

I am currently on immune-suppressing medication for a condition like uveitis, IBD, or related to PsO.

Other protocol-defined inclusion/exclusion criteria apply

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986322 or placebo to evaluate clinical effectiveness and safety

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BMS-986322

Trial Overview The study tests the effectiveness and safety of BMS-986322 compared to a placebo in treating moderate-to-severe psoriasis. Participants will randomly receive either the actual drug or a placebo without knowing which one they are getting.

Participant Groups

Group I: BMS-986322 Dose 3 Experimental Treatment 1 Intervention

Group II: BMS-986322 Dose 2 Experimental Treatment 1 Intervention

Group III: BMS-986322 Dose 1 Experimental Treatment 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

In a study of 221 patients with moderate plaque psoriasis, apremilast significantly improved skin condition, achieving a 48.1% reduction in the combined score of disease severity compared to only 10.2% with placebo after 16 weeks.

Apremilast was well tolerated, with most side effects being mild to moderate, and it notably enhanced patients' quality of life and satisfaction with treatment compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Apremilast in Patients With Moderate Plaque Psoriasis With Lower BSA: Week 16 Results from the UNVEIL Study. Strober, B., Bagel, J., Lebwohl, M., et al.[2018]

In a study of 34 patients with moderate-to-severe plaque psoriasis treated with apremilast for 26 weeks, 41% achieved significant improvement (delta PASI 75), indicating the drug's efficacy in managing psoriasis symptoms.

Genome-wide analysis identified specific genetic markers associated with treatment response to apremilast, suggesting that genetic profiling could help predict which patients will benefit most from this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apremilast Pharmacogenomics in Russian Patients with Moderate-to-Severe and Severe Psoriasis. Verbenko, DA., Karamova, AE., Artamonova, OG., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Apremilast in Patients With Moderate Plaque Psoriasis With Lower BSA: Week 16 Results from the UNVEIL Study. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris--A randomized phase II study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Biologic response modifier therapy for psoriatic ocular inflammatory disease. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Apremilast Pharmacogenomics in Russian Patients with Moderate-to-Severe and Severe Psoriasis. [2021]