A Phase 2 Clinical Study to Assess the Safety and Efficacy of Deucravacitinib in Participants with Active DLE and/or SCLE

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

4 Jun 2021 → ongoing

Decision date (initial)

2023-08-22

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bristol-Myers Squibb International Corporation

External identifiers

EU CT number

2023-504161-22-00

EudraCT number

2020-000071-21

WHO UTN

U1111-1246-1726

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To evaluate the effect of two doses of deucravacitinib (3 mg BID and 6 mg BID) compared with placebo on CLASI-A score at Week 16

Secondary objectives 2

1. To evaluate additional clinical measures of cutaneous disease manifestations with two doses of deucravacitinib (3 mg BID and 6 mg BID) compared with placebo at Week 16
2. To assess the safety and tolerability of two doses of deucravacitinib (3 mg BID and 6 mg BID) compared with placebo

Conditions and MedDRA coding

Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participants must have a diagnosis of DLE/SCLE
2. Cutaneous Lupus Erythematosus Disease Area and Severity Index- Activity (CLASI-A) score ≥ 8
3. Participants must currently be receiving stable treatment regimen for CLE
4. For optional long term extension treatment period: Completion of Study IM011132 through the protocol-required active treatment period (ie up to and including week 52 treatment visit).
5. For optional long-term extension treatment period: Participant is, based on the invesigators medical judgement, likely to receive benefit from receiving treatment with deucravacitinib.

Exclusion criteria 2

1. Participants with forms of drug-induced CLE and/or drug-induced SLE
2. Participants with other non-SLE driven inflammatory conditions that will significantly impact the assessment of CLE/SLE disease manifestations and activity

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage change from baseline in CLASI activity (CLASIA) score

Secondary endpoints 5

1. Percentage of participants with an improvement of ≥ 50% from baseline in the CLASI-A score (CLASI-50)
2. Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of ≥ 4 points from baseline
3. Mean change from baseline in CLASI-A score
4. Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of "0"
5. Number and proportion of participants experiencing SAEs, AEs (with severity and relationship of AEs), and abnormalities in laboratory testing, vital signs, and 12-lead ECGs

Investigational products

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

Test 2

Placebo 2

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 International Corporation

Contact name

GSM-CT

Public contact point

Organisation

Bristol Myers Squibb International Corporation

Contact name

GSM-CT

Third parties 6

Locations

3 EU/EEA countries · 9 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 33 files

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

Application history

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