Deucravacitinib for Psoriasis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
PsoriasisDeucravacitinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness and safety of a new drug, deucravacitinib, to placebo in people with moderate to severe scalp psoriasis.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Up to 56 Weeks

At Week 16
Change from Baseline in Scalp-specific Itch Numeric Rating Scale (NRS) Score
Proportion of Participants Who Achieve Psoriasis Scalp Severity Index (PSSI) Response 90
Proportion of Participants Who Achieve Scalp-Specific Physician's Global Assessment (ss-PGA) Score 0 (clear) or 1 (almost clear) with at least a 2-point Reduction from Baseline
Up to 56 Weeks
Number of Participants with Adverse Events (AEs)
Number of Participants with Clinical Laboratory Abnormalities
Number of Participants with Physical Examination Abnormalities
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with Vital Sign Abnormalities

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Arm 1: BMS-986165
18%Upper respiratory tract infection
8%Mouth ulceration
7%Nasopharyngitis
5%Headache
4%Pruritus
3%Psoriasis
1%Cholecystitis
1%Gastroenteritis
1%Gastroenteritis shigella
1%Accidental overdose
1%Hepatobiliary procedural complication
1%Psoriatic arthropathy
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT04167462) in the Arm 1: BMS-986165 ARM group. Side effects include: Upper respiratory tract infection with 18%, Mouth ulceration with 8%, Nasopharyngitis with 7%, Headache with 5%, Pruritus with 4%.

Trial Design

2 Treatment Groups

Deucravacitinib
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

150 Total Participants · 2 Treatment Groups

Primary Treatment: Deucravacitinib · Has Placebo Group · Phase 3

Deucravacitinib
Drug
Experimental Group · 1 Intervention: Deucravacitinib · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deucravacitinib
2021
Completed Phase 1
~70

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 56 weeks

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,500 Previous Clinical Trials
3,927,372 Total Patients Enrolled
28 Trials studying Psoriasis
15,822 Patients Enrolled for Psoriasis

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have evidence of plaque psoriasis in a non-scalp area.
You have failed to respond to, or are intolerant of ≥ 1 topical therapy for scalp psoriasis.
Scalp-specific Physician's Global Assessment (ss-PGA) ≥ 3; ≥ 20% scalp surface area (SSA); Psoriasis Scalp Severity Index (PSSI) ≥ 12 at Screening visit and Day 1.