Efficacy and Safety of Deucravacitinib Compared with Placebo in Participants with Active SLE (POETYK SLE-2)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

25 May 2023 → ongoing

Decision date (initial)

2023-10-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bristol-Myers Squibb International Corporation

External identifiers

EU CT number

2022-500700-22-00

WHO UTN

U1111-1279-6951

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic, Pharmacodynamic, Therapy, Others

To demonstrate superiority of deucravacitinib compared to PBO in treatment of participants with SLE with respect to SRI (4).

Secondary objectives 1

1. To evaluate the efficacy of deucravacitinib compared to PBO on additional measures of clinical disease activity. To assess fatigue status in participants with active SLE. To assess the safety and tolerability of deucravacitinib in participants with active SLE.

Conditions and MedDRA coding

Active Systemic Lupus Erythematosus (SLE)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Male and female participants aged 18(or local age of majority, if older) to 75 years of age, inclusive, diagnosed with SLE at least 24 weeks prior to screening and meet the European Alliance of Associations for Rheumatology/American College of Rheumatology 2019 classification criteria for SLE. Participants must test positive for at least 1 of the following lupus-related autoantibodies at the time of screening: antinuclear antibodies (ANA)≥ 1:80, anti-dsDNA antibody, or anti-Smith (anti- Sm). Participants must have active lupus defined as a total SLEDAI-2K score≥6 points, and clinical SLEDAI-2K score ≥ 4 points, and must include joint involvement and/or cutaneous vasculitis, and/or rash. Participants must be on stable background therapy with anti-malarial agents and/or immunosuppressants. Participants may also be on corticosteroids.

Exclusion criteria 1

1. Participants with any of the following diagnoses are excluded: drug induced SLE, most autoimmune disease (e.g. multiple sclerosis, inflammatory bowel disease, etc), SLE overlap syndromes including rheumatoid arthritis, scleroderma and mixed connective tissue disease, catastrophic anti-phospholipid syndrome or anti-phospholipid syndrome not maintained on appropriate therapy, or there has been a thrombotic event or pregnancy morbidity, active severe lupus nephritis, active severe neuropsychiatric lupus, congenital or acquired immunodeficiency condition. Participants on investigational agents or prohibited immunomodulatory or biologics medications within applicable wash-out period are excluded. Participants using prohibited corticosteroid formulations or prohibited routes of administration (e.g. modified release CS formulation, high-potency topic CS, intramuscular, intra-articular, intra-bursal, and IV), receiving therapy for active or chronic infection are also excluded.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants who achieve SRI(4) response at Week 52

Secondary endpoints 4

1. Proportion of participants who achieve BICLA response at Week 52. Proportion of participants who achieve both SRI(4)and BICLA (dual responders) at Week 52.
2. Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score at Week 52. Proportion of participants who achieve LLDAS at Week 52.
3. Proportion of participants with OCS ≥ 7.5 mg/day of prednisone (or equivalent) at baseline who are receiving ≤ 5 mg/day of prednisone (or equivalent) at Week 40 which is maintained through Week 52 and who achieve an SRI(4) response at Week protocol- specified limits to Week 52. Proportion of participants with ≥ 6 active (tender+ swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints at Week 52.
4. Change from baseline in patient-reported fatigue according to FACIT-Fatigue at Week 52. Incidence of AEs, SAEs, AEs leading to discontinuation of treatment and study discontinuation, and target AESIs; change from baseline and/or abnormalities in laboratory, electrocardiogram (ECG), and vital signs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

Global Submission Management - Clinical Trials

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

Global Submission Management - Clinical Trials

Third parties 17

Locations

7 EU/EEA countries · 36 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 2 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 112 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

19 submissions — initial application plus substantial / non-substantial modifications