Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol Myers Squibb International Corporation

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

28 May 2019 → 21 Mar 2025

Decision date (initial)

2023-10-19

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

2022-502444-13-00

EudraCT number

2018-003471-35

ClinicalTrials.gov

NCT03920267

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To characterize the long-term safety and tolerability of BMS-986165 in subjects with SLE

Secondary objectives 3

1. Efficacy: To characterize the long-term maintenance of response of BMS-986165 in the treatment of subjects with SLE To characterize patient-reported outcomes in subjects with SLE on long-term BMS-986165 therapy
2. Pharmacokinetic: To explore long-term pharmacokinetics of BMS-986165
3. Pharmacodynamic: To explore long-term pharmacodynamics of BMS-986165

Conditions and MedDRA coding

Systemic Lupus Erythematosus

Regulatory references

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 3

1. 1)Signed Written Informed Consent
2. 2) Type of Subject and Target Disease Characteristics a) Completion of Study IM011021 through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product [IP] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee.
3. 3) Reproductive Status a) Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of study drug. b) Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the study period. c) WOCBP must agree to use correctly a highly effective or less than highly effective method(s) of contraception for the duration of treatment with study drug(s) BMS-986165 plus 5 half-lives of study drug (3 days) plus 30 days (duration of ovulatory cycle) for a total of 33 days posttreatment completion (total of 33 days after last dose of study drug). WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements, but must still undergo pregnancy testing as described in protocol APPENDIX 4. d) Male subjects who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (APPENDIX 4) for the duration of treatment with study treatment BMS-986165. e) Azoospermic males are exempt from contraceptive requirements.

Exclusion criteria 2

1. 1) Medical History and Concurrent Diseases a) Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason
2. 2) Findings Related to Possible Tuberculosis (TB) Infection a) Evidence of active TB

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Adverse events and serious adverse events, vital sign measurements, and laboratory parameters

Secondary endpoints 15

1. Efficacy: CLASI response
2. 40-joint count for tender, swollen, and tender + swollen joints
3. SRI(4) response
4. BICLA response
5. PGA
6. Corticosteroid use (yes/no)
7. Corticosteroid dose ≤7.5 mg/day (yes/no)
8. Flare Analysis o Time to first flare o Number and frequency of flares o Flares leading to hospitalization
9. SDI total score
10. BILAG response
11. SLEDAI-2K score
12. LLDAS response
13. PROMIS Fatigue Short Form 7a score
14. Pharmacokinetic: - Plasma concentrations of BMS-986165
15. Pharmacodynamic: - dsDNA, CRP, Complement levels, UPCR

Investigational products

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

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol Myers Squibb International Corporation

Sponsor organisation

Bristol Myers Squibb International Corporation

Address

Terhulpsesteenweg 185

City

Watermaal-Bosvoorde

Postcode

1170

Country

Belgium

Scientific contact point

Organisation

Bristol Myers Squibb International Corporation

Contact name

GCT-SU

Public contact point

Organisation

Bristol Myers Squibb International Corporation

Contact name

GCT-SU

Third parties 5

Locations

4 EU/EEA countries · 20 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 10 files

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

Application history

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