Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults with Active Sjögren’s Syndrome

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

31 Jan 2024 → ongoing

Decision date (initial)

2023-12-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bristol-Myers Squibb Services Unlimited Company

External identifiers

EU CT number

2023-503327-26-00

WHO UTN

U1111-1289-6072

ClinicalTrials.gov

NCT05946941

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To compare the efficacy of deucravacitinib versus placebo in participants with active SjS by ESSDAI improvement at Week 52

Secondary objectives 2

1. To compare the efficacy of deucravacitinib versus PBO in participants with active SjS by additional measures of clinical disease activity, organ function and patient reported outcomes at Week 52
2. To assess the safety and tolerability of deucravacitinib in participants with active SjS up to Week 52

Conditions and MedDRA coding

Sjogren's syndrome

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Eligible participants will include adults (≥ 18 years old or local age of majority) who satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS, have moderate to severe SjS (ESSDAI ≥ 5), and be positive for anti-SSA/Ro antibody. Other eligibility criteria will include short duration of disease (≤ 10 years) and a SWSF ≥ 0.05 mL/minute

Exclusion criteria 1

1. Participants with the following diagnoses are excluded: autoimmune disease other than SjS (e.g. rheumatoid arthritis, SLE, systemic sclerosis), active fibromyalgia, medical condition(s) associated with sicca syndrome, severe complications of SjS (vasculitis, lymphoma, active central nervous system or peripheral nervous system involvement, severe renal/pulmonary/muscular involvement). Participants with prior exposure to deucravacitinib or TYK2 inhibitor, prior exposure to biological therapy within washout period or receiving therapy for active or chronic infection are also excluded.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in ESSDAI at Week 52

Secondary endpoints 13

1. Change from baseline in ESSPRI at Week 52
2. Proportion of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52
3. Proportion of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52
4. Proportion of participants with ESSDAI < 5 at Week 52
5. Change from baseline in ESSDAI at Week 24
6. Change from baseline in SWSF at Week 52
7. Change from baseline in PhGA at Week 52
8. Change from baseline in FACIT-Fatigue at Week 52
9. Change from baseline in ocular dryness NRS at Week 52
10. Change from baseline in oral dryness NRS at Week 52
11. Change from baseline in joint/muscle pain NRS at Week 52
12. Incidence of AEs, SAEs, AEs leading to discontinuation of treatment and study discontinuation, and target AEIs; change in laboratory, ECG, and vital signs; and abnormalities in laboratory, ECG, and vital signs
13. Proportion of participants with increase of Schirmer's test ≥ 5 mm if abnormal baseline or No change of Schirmer's test to abnormal if normal baseline at Week 52

Investigational products

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

Test 2

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, Ballycoolin Ballycoolin

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Third parties 14

Locations

15 EU/EEA countries · 58 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 473 files

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

Application history

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