A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06042920
• Collaborator: (none)
• Enrollment: 360
• Locations: 25
• Arms: 2
• Anticipated Duration (Months): 29.3
• Patients Per Site: 14.4
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis.

Condition or Disease	Intervention/Treatment	Phase
Palmoplantar Psoriasis; Genital Psoriasis	Drug: Deucravacitinib; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Non-Pustular PalmoPlantar and Genital Psoriasis (Psoriatyk Special Sites)
• Anticipated Study Start Date: Sep 15, 2023
• Anticipated Primary Completion Date: Feb 23, 2026
• Anticipated Study Completion Date: Feb 23, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Deucravacitinib	Drug: Deucravacitinib; Specified dose on specified days; Other Names: BMS-986165 SOTYKTU
Placebo Comparator: Placebo followed by Deucravacitinib	Drug: Deucravacitinib; Specified dose on specified days; Other Names: BMS-986165 SOTYKTU ; Drug: Placebo; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a 75% Improvement in Palmoplantar Psoriasis Area and Severity Index (pp-PASI-75) Score [Baseline to Week 16]

2. Number of Participants With Static Physician Global Assessment Genitals (s-PGA-G) Score of 0 (Clear ) or 1 (Almost Clear), With At Least a 2-Point Reduction [Baseline to Week 16]

Secondary Outcome Measures

1. Number of Participants With Palmoplantar Physician Global Assessment (pp-PGA) Score of 0 (Clear) or 1 (Almost Clear), With At Least a 2-Point Reduction [Baseline to Week 16]

2. Number of Participants With Static Physician Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear), With Least a 2-Point Reduction [Baseline to Week 16]

3. Change from baseline in Genital Psoriasis (GenPs) Itch Numeric Rating Scale (NRS) score [Baseline to Week 16]

4. Number of Participants With Adverse Events (AEs) [Up to Week 16]

5. Number of Participants With Serious Adverse Events (SAEs) [Up to Week 16]

6. Number of Participants With Clinical Laboratory Abnormalities [Up to Week 16]

7. Number of Participants With Vital Sign Abnormalities [Up to Week 16]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

Inclusion Criteria for Non-Pustular Palmoplantar Psoriasis

• Men and women diagnosed with stable plaque psoriasis with involvement of the palm(s)and/or sole(s) for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.

• Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1.

• Moderate-to-severe non-pustular PP psoriasis, defined as pp-PGA score of ≥ 3 on a 5-pointscale and pp-PASI ≥ 8 at both screening visit and Day 1.

• A total maximum of 5 sterile pustules across both palms and soles limited only to psoriatic plaques will be allowed.

• Evidence of typical plaque psoriasis outside palms and soles at both screening visit and Day 1.

• Deemed by the investigator to be a candidate for phototherapy or systemic therapy.

• Failed to respond to, or intolerant of ≥ 1 topical therapy.

Inclusion Criteria for Genital Psoriasis

• Men and women diagnosed with stable plaque psoriasis with involvement of the genital area for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.

• Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1.

• Moderate-to-severe GenPs, defined as static Physician's Global Assessment of Genitalia (s-PGA-G) score of ≥ 3 on a 6-point scale at both screening visit and Day 1.

• Evidence of typical plaque psoriasis in a non-genital area at both screening visit and Day 1.

• Deemed by the investigator to be a candidate for phototherapy or systemic therapy.

• Failed to respond to, or intolerant of ≥ 1 topical therapy.

Key Exclusion Criteria:

Target Disease Exceptions

• Has non-plaque psoriasis (for PP pustulosis, PP pustular psoriasis, isolated pustules on palms or soles with or without erythema outside psoriatic plaques, guttate, pustular, erythrodermic, and drug-induced psoriasis) at screening or Day 1.

Other protocol-defined inclusion/exclusion criteria apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Whitaker Clinic of UAB Hospital	Birmingham	Alabama	United States	35233-3110
2	Dermatology Research Associates - Howard Sofen, MD	Los Angeles	California	United States	90045-3606
3	Aesthetic and Dermatology Center	Rockville	Maryland	United States	20850-6487
4	Henry Ford Medical Center - New Center One	Detroit	Michigan	United States	48202-3141
5	Windsor Dermatology - Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey	United States	08520-2505
6	Oregon Medical Research Center	Portland	Oregon	United States	97223-6683
7	Virginia Clinical Research	Norfolk	Virginia	United States	23502-3933
8	North Sound Dermatology - Mill Creek	Mill Creek	Washington	United States	98012-1797
9	Local Institution - 0037	Ciudad Autónoma Buenos Aires	B	Argentina	C1428DZF
10	Local Institution - 0034	Ciudad Autonoma Buenos Aires	C	Argentina	C1425DKG
11	Local Institution - 0028	Berlin	BE	Germany	10789
12	Local Institution - 0030	Memmingen	BY	Germany	87700
13	Local Institution - 0017	Frankfurt am Main	Hesse	Germany	60590
14	Local Institution - 0016	Hamburg	HH	Germany	20246
15	Local Institution - 0027	Witten	Northwest	Germany	58453
16	Local Institution - 0040	Brescia	BS	Italy	25123
17	Local Institution - 0039	Roma	RM	Italy	00133
18	Local Institution - 0036	Wroclaw	DS	Poland	50-566
19	Local Institution - 0038	Warsaw	Mazowieckie	Poland	02-962
20	Local Institution - 0035	Bialystok	PD	Poland	15-351
21	Local Institution - 0032	Rzeszow	PK	Poland	35-055
22	Local Institution - 0031	Warszawa		Poland	02-507
23	Local Institution - 0024	Madrid	M	Spain	28006
24	Local Institution - 0018	Córdoba	X	Spain	14004
25	Local Institution - 0023	Barcelona		Spain	08041

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Description: BMS Clinical Trial Information
• FDA Safety Alerts and Recalls
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT06042920
• Other Study ID Numbers: IM011-1112; 2023-504663-16; U1111-1289-6934
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Deucravacitinib; BMS-986165; SOTYKTU; Plaque psoriasis
• Additional relevant MeSH terms: Psoriasis; Deucravacitinib

Study Results

No Results Posted as of Sep 21, 2023