Clinical trial NCT05478499: Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis
Official title: A Phase 3B/4, Multicenter, Randomized, Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Moderate-to-severe Scalp Psoriasis (PSORIATYK SCALP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: Scalp Psoriasis
BMS-986165
Deucravacitinib
Psoriasis
Psoriasis Special Sites
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-07-28
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.


Eligibility criteria: Inclusion Criteria:

1. Men and women diagnosed with stable plaque psoriasis with scalp involvement for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the Investigator
2. Deemed by the Investigator to be a candidate for phototherapy or systemic therapy
3. Moderate-to-severe scalp psoriasis as defined by scalp-specific Physician's Global Assessment (ss-PGA) ≥ 3; ≥ 20% scalp surface area (SSA); Psoriasis Scalp Severity Index (PSSI) ≥ 12 at the Screening visit and Day 1
4. ≥ 3% of Body Surface Area (BSA) involvement at the Screening visit and Day 1
5. Evidence of plaque psoriasis in a non-scalp area
6. Failed to respond to, or intolerant of ≥ 1 topical therapy for scalp psoriasis

Exclusion Criteria:

* Target Disease Exceptions:

  1. Has nonplaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis) at Screening or Day 1 Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16
timeFrame: Baseline and Week 16
measure: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
timeFrame: From week 0 through week 16
measure: Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs)
timeFrame: From week 0 through week 16
measure: Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
timeFrame: Week 0 through Week 16
measure: Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests
timeFrame: Week 0 through Week 16
measure: Number of Participants With Abnormalities in Vital Signs
timeFrame: Week 0 through Week 16
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Local Institution - 0001
state: Arkansas
city: Indianapolis
country: United States
facility: Local Institution - 0007
state: Indiana
city: Louisville
country: United States
facility: Local Institution - 0041
state: Kentucky
city: Rockville
country: United States
facility: Local Institution - 0022
state: Maryland
city: Beverly
country: United States
facility: Local Institution - 0008
state: Massachusetts
city: Bloomfield Hills
country: United States
facility: Local Institution - 0047
state: Michigan
city: New Brighton
country: United States
facility: Local Institution - 0002
state: Minnesota
city: East Windsor
country: United States
facility: Local Institution - 0049
state: New Jersey
city: Kew Gardens
country: United States
facility: Local Institution - 0051
state: New York
city: Portland
country: United States
facility: Local Institution - 0003
state: Oregon
city: Pittsburgh
country: United States
facility: Local Institution - 0005
state: Pennsylvania
city: Houston
country: United States
facility: Local Institution - 0033
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0004
state: Texas
city: Norfolk
country: United States
facility: Local Institution - 0006
state: Virginia
city: Paris
country: France
facility: Local Institution - 0019
city: Romans sur Isere Cedex
country: France
facility: Local Institution - 0040
city: Rouen Cedex
country: France
facility: Local Institution - 0044
city: Witten
country: Germany
facility: Local Institution - 0038
state: Deutschland
city: Frankfurt
country: Germany
facility: Local Institution - 0013
state: Hessen
city: Hamburg
country: Germany
facility: Local Institution - 0048
city: Luebeck
country: Germany
facility: Local Institution - 0012
city: Mahlow
country: Germany
facility: Local Institution - 0011
city: Krakow
country: Poland
facility: Local Institution - 0026
city: Lodz
country: Poland
facility: Local Institution - 0017
city: Rzeszow
country: Poland
facility: Local Institution - 0014
city: Wroclaw
country: Poland
facility: Local Institution - 0015
city: London
country: United Kingdom
facility: Local Institution - 0031
state: Greater London
city: Salford
country: United Kingdom
facility: Local Institution - 0045
state: Greater Manchester
city: Southampton
country: United Kingdom
facility: Local Institution - 0039
state: Hampshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_CHAIR
References: