BMS-986322 for Psoriasis

No longer recruiting at 77 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, BMS-986322, for individuals with moderate-to-severe psoriasis, a skin condition that causes itchy, scaly patches. Researchers aim to evaluate the treatment's effectiveness and safety. Participants will receive varying doses of BMS-986322 (an experimental treatment) or a placebo (a substance with no active medication) to compare effects. Those with plaque psoriasis for at least six months, with patches covering 10% or more of the body, might qualify for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant advancements in psoriasis care.

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.

Is there any evidence suggesting that BMS-986322 is likely to be safe for humans?

Research has shown that BMS-986322 was safe in past studies with adults who have moderate-to-severe plaque psoriasis. Over five years, it consistently proved safe, with most patients handling the treatment well without serious side effects. While this doesn't guarantee the same results for everyone, the past data encourages those considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriasis?

Researchers are excited about BMS-986322 for psoriasis because it offers a potentially new way to tackle the condition. Unlike current treatments like biologics and topical steroids, which often target specific proteins or inflammation pathways, BMS-986322 works by a unique mechanism that may offer improved effectiveness. It's being tested in different doses to optimize its impact, which could provide more tailored treatment options for patients. This novel approach might lead to better outcomes for those who haven't responded well to existing therapies.

What evidence suggests that BMS-986322 could be an effective treatment for psoriasis?

Research has shown that BMS-986322 offers promising results for treating moderate-to-severe psoriasis. In earlier studies, 71.7% of patients experienced a 75% reduction in symptoms, and 47.5% achieved a 90% reduction after four years. Many patients, therefore, saw significant improvement in their psoriasis. The treatment also maintained a consistent safety record and long-lasting effects over five years. These findings suggest that BMS-986322 could effectively manage psoriasis symptoms. ^{1 3 4 6 7}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05730725

NCT05730725 | A Study to Evaluate Effectiveness and ... The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis. Official Title. A ...

2. bmsstudyconnect.com bmsstudyconnect.com/dk/en/clinical-trials/NCT05730725.html

A Study to Evaluate Effectiveness and Safety of BMS-986322 ... The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis.

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/bms-psoriasis-extension-trial/

BMS reports four-year data from psoriasis treatment ... After four years, the Psoriasis Area and Severity Index (PASI) 75 and 90 response rates were 71.7% and 47.5%, respectively. A 57.2% rate for ...

4. bmsclinicaltrials.com bmsclinicaltrials.com/us/en/clinical-trials/NCT05730725

Trial ID IM032-041 | NCT05730725 - BMS Clinical Trials The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis.

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/bms-sotyktu-psoriasis-trial/

BMS' Sotyktu shows consistent safety profile in psoriasis trial The drug showed consistent safety and durable response rates in adult patients with moderate-to-severe plaque psoriasis over five years.

6. bmsstudyconnect.com bmsstudyconnect.com/it/en/clinical-trials/NCT05730725.html

A Study to Evaluate Effectiveness and Safety of BMS-986322 ... The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis.

7. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-effectiveness-and-safety-of-bms-986322-in-participants-with-moderate-to-severe-p

A Study to Evaluate Effectiveness and Safety of BMS-986322 ... The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis.