A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04857034
• Collaborator: (none)
• Enrollment: 75
• Locations: 41
• Arms: 3
• Anticipated Duration (Months): 39.2
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if deucravacitinib is biologically active and potentially effective in the treatment of participants with moderate to severe DLE/SCLE with or without systemic lupus erythematosus (SLE) that is not well controlled with standard of care therapy.

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus, Discoid; Lupus Erythematosus, Subacute Cutaneous	Drug: Deucravacitinib; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
• Actual Study Start Date: Jul 12, 2021
• Anticipated Primary Completion Date: Oct 16, 2023
• Anticipated Study Completion Date: Oct 18, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Treatment: Deucravacitinib Dose 1	Drug: Deucravacitinib; Specified dose on specified days
Experimental: Active Treatment: Deucravacitinib Dose 2	Drug: Deucravacitinib; Specified dose on specified days
Placebo Comparator: Placebo	Drug: Placebo; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Percentage change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score at week 16 [Week 16]

Secondary Outcome Measures

1. Percentage of participants with an improvement of ≥ 50% from baseline in the CLASI-A score (CLASI- 50) [Week 16]

2. Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of ≥ 4 points from baseline [Week 16]

3. Mean change from baseline in CLASI-A score [Week 16]

4. Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of "0" [Week 16]

5. Incidence of serious adverse events (SAEs) [Up to 60 weeks]

6. Incidence of adverse events (AEs) [Up to 56 weeks]

7. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 56 weeks]

8. Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests [Up to 56 weeks]

9. Incidence of clinically significant changes in clinical laboratory results: Urinalysis [Up to 56 weeks]

10. Incidence of clinically significant changes in vital signs: Body temperature [Up to 56 weeks]

11. Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 56 weeks]

12. Incidence of clinically significant changes in vital signs: Blood pressure [Up to 56 weeks]

13. Incidence of clinically significant changes in vital signs: Heart rate [Up to 56 weeks]

14. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval [Up to 56 weeks]

    PR interval: The time from the onset of the P wave to the start of the QRS complex

15. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval [Up to 56 weeks]

    QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization

16. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval [Up to 56 weeks]

    QT interval: Measured from the beginning of the QRS complex to the end of the T wave

17. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval [Up to 56 weeks]

    QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of discoid/subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months prior to screening visit

• Meets both clinical and histopathological diagnostic cutaneous lupus erythematosus (CLE) criteria per protocol

• Currently receiving treatment for DLE/SCLE with a stable regimen of at least one of the following medications: oral corticosteroid, and/or antimalarial, and/or immunosuppressant

• Participant could be with or without concurrent systemic lupus erythematosus (SLE)

• If participant receives nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics treatment then the participant must be on a stable dose 2 weeks prior to screening

Exclusion Criteria:

• Women who are pregnant, lactating, breastfeeding or planning pregnancy during the study period

• Any of the following specific CLE subtypes in isolation: acute cutaneous lupus erythematosus (ACLE), lupus tumidus, lupus (profundus) panniculitis, chilblains

• Drug-induced CLE and/or drug-induced systemic lupus erythematosus (SLE)

• Antiphospholipid antibody syndrome, serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit

• History of 3 or more unexplained consecutive pregnancy losses

• Active severe or unstable neuropsychiatric SLE

• Other autoimmune diseases or non-SLE driven inflammatory joint or skin disease or overlap syndromes as primary disease that in the opinion of the investigator will significantly impact the assessment of CLE/SLE disease manifestations and activity

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution - 0046	Los Angeles	California	United States	90045
2	University Of Michigan	Ann Arbor	Michigan	United States	48109
3	Washington University School Of Medicine	Saint Louis	Missouri	United States	63108
4	Icahn School Of Medicine At Mount Sinai	New York	New York	United States	10029
5	Duke Health Center South Durham	Durham	North Carolina	United States	27713
6	Local Institution	Columbus	Ohio	United States	43215
7	Ohio State University Wexner Medical Centre-Dermatology West	Columbus	Ohio	United States	43215
8	Oklahoma Medical Research Foundation-ORRC	Oklahoma City	Oklahoma	United States	73104
9	Clinical Research Center of the Carolinas	Charleston	South Carolina	United States	29407
10	Local Institution	Rapid City	South Dakota	United States	57702
11	Stat Research S.A.-Dermatology	Capital Federal	Buenos Aires	Argentina	1023
12	Local Institution - 0013	San Miguel De Tucuman	Tucuman	Argentina	4000
13	Local Institution - 0019	Buenos Aires		Argentina	1431
14	Local Institution	Cordoba		Argentina
15	Local Institution	Botany	New South Wales	Australia	2019
16	Local Institution	Sydney	New South Wales	Australia	2217
17	Local Institution	Camberwell	Victoria	Australia	3142
18	Local Institution - 0007	Clayton	Victoria	Australia	0
19	Local Institution	Bordeaux		France	33075
20	Local Institution - 0027	Créteil		France	94000
21	Local Institution - 0010	Paris		France	75970
22	Local Institution	Strasbourg		France	67098
23	Local Institution - 0035	Berlin		Germany	10117
24	Local Institution - 0014	Erlangen		Germany	91054
25	Local Institution - 0006	Hamburg		Germany	22391
26	Local Institution - 0071	Mexico City	Distrito Federal	Mexico	14080
27	Local Institution	Guadalajara	Jalisco	Mexico	44650
28	Local Institution	Guadalajara	Jalisco	Mexico	45030
29	Local Institution - 0058	Zapopan	Jalisco	Mexico	45070
30	Local Institution	Monterrey	Nuevo LEON	Mexico	64718
31	Local Institution - 0029	Aguascalientes		Mexico	20130
32	Local Institution - 0008	Lodz		Poland	94-047
33	Local Institution - 0005	Rzeszów		Poland	35-055
34	Local Institution	Wroclaw		Poland	50-566
35	Local Institution	Kemerovo		Russian Federation	650070
36	Local Institution	Moscow		Russian Federation	119021
37	Local Institution	Moscow		Russian Federation	121205
38	Local Institution - 0031	Kaohsiung		Taiwan	833
39	Local Institution - 0023	Taichung City		Taiwan	402
40	Local Institution	Taichung		Taiwan	404
41	Local Institution - 0022	Taipei		Taiwan	10051

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:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04857034
• Other Study ID Numbers: IM011-132; 2020-000071-21; U1111-1246-1726
• First Posted: Apr 23, 2021
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: BMS-986165; Deucravacitinib; DLE; Discoid Lupus Erythematosus; SCLE; Subacute Cutaneous Lupus Erythematosus
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid

Study Results

No Results Posted as of Aug 19, 2022