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Monoclonal Antibodies

BMS-986322 for Psoriasis

Phase 2
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Psoriatic plaques must cover ≥ 10% of body surface area at baseline
Body mass index 18 to 40 kg/m^2 and total body weight > 50 kg (110 lbs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights

Study Summary

This trial looks at how safe & effective a new psoriasis treatment is, in people with moderate-to-severe psoriasis.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with treatments like BMS-986322 may include skin reactions at injection sites, infections due to lowered immunity, headaches, fatigue, and possible liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My psoriasis covers 10% or more of my body.
Select...
My BMI is between 18 and 40, and I weigh more than 50 kg (110 lbs).
Select...
I have been diagnosed with plaque psoriasis for at least 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with TEAEs leading to treatment discontinuation
Number of participants with clinical laboratory abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
+5 more
Secondary outcome measures
Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)] of BMS-986322
BMS-986322 trough concentrations
Change from baseline in PASI score
+10 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: BMS-986322 Dose 3Experimental Treatment1 Intervention
Group II: BMS-986322 Dose 2Experimental Treatment1 Intervention
Group III: BMS-986322 Dose 1Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986322
2022
Completed Phase 1
~330

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,636 Previous Clinical Trials
4,127,444 Total Patients Enrolled
35 Trials studying Psoriasis
19,360 Patients Enrolled for Psoriasis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible for participation in this clinical trial?

"To be deemed eligible for this trial, individuals must have psoriasis and fall into the specified age range of 18 to 70. A total of 120 volunteers are needed for the clinical trial."

Answered by AI

Is this research endeavor accepting participants aged 35 and above?

"Eligible candidates who wish to participate in this medical trial must be between 18 and 70 years of age. There are 29 trials available for minors and 130 studies open to the elderly population."

Answered by AI

Is recruitment still underway for this medical experiment?

"As per the records on clinicaltrials.gov, this research project is currently seeking participants. It was posted online on April 3rd 2023 and updated as recently as May 8th of the same year."

Answered by AI

Are there several medical centers operating this clinical research in Canada?

"Southern California Dermatology, Inc in Santa Ana, Renstar Medical Research in Ocala and Dermatology Specialists Research - Indiana in Clarksville are amongst the 48 clinical trial sites operating for this study."

Answered by AI

Has the FDA granted authorization for BMS-986322 Dose 2?

"Our team at Power evaluated BMS-986322 Dose 2's safety with a score of 2, as the evidence for its efficacy is still limited in spite of some data confirming that it is safe."

Answered by AI

How many people are actively participating in this medical experiment?

"The sponsor, Bristol-Myers Squibb, needs to recruit 120 suitable participants for this clinical trial. Southern California Dermatology in Santa Ana and Renstar Medical Research in Ocala are two of the multiple sites responsible for running the study."

Answered by AI

Who else is applying?

What site did they apply to?
Pure Dermatology NOLA
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I’ve tried many drugs both topical and oral and they are not effective.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis
2023. "A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05730725.
All > Psoriasis > Plaque Psoriasis
~9 spots leftby May 2024
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