"Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment."

• Register: EUCTR
• Last refreshed on: 23 October 2023
• Main ID: EUCTR2019-002205-22-ES
• Date of registration: 23/01/2020
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb International Corporation
• Public title: "Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment."
• Scientific title: "A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis". - SLE Sub-protocol: "Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus." - pSS Sub-protocol: "Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome." - RA Sub-protocol: "Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis."
• Date of first enrolment: 06/04/2020
• Target sample size: 185
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-002205-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 7
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Belgium, France, Germany, Mexico, Netherlands, Poland, Spain, United Kingdom, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Bristol-Myers Squibb International Corporation

• Name: Clinical Trial Information Desk
• Affiliation: Bristol-Myers Squibb International Corporation

Key inclusion & exclusion criteria

Inclusion criteria:
Sub-Protocol for Systemic Lupus Erythematosus (SLE):
- Active SLE as defined by the Systemic Lupus Erythematosus
International Collaborating Clinics (SLICC) classification.
- Diagnosed with SLE more than 24 weeks before screening visit.

Sub-Protocol for primary Sjögren's Syndrome (pSS):
- Moderate to severe pSS, meeting ACR-EULAR classification criteria.

Sub-Protocol for active Rheumatoid Arthritis (RA):
- Moderate to severe adult-onset RA.
- ACR global functional status class I to III.
For all sub-studies:
- Women and men must agree to follow instructions for methods of
contraception.

Please, be referred to the Protocol document for a complete list of
Inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
Sub-Protocol for Systemic Lupus Erythematosus (SLE):
- Certain other autoimmune diseases and overlap syndromes.
Sub-Protocol for primary Sjögren's Syndrome (pSS):
- Certain other immune-mediated diseases, active fibromyalgia, or other medical conditions.
Sub-Protocol for Rheumatoid Arthritis (RA):
- Diagnosis with juvenile arthritis or idiopathic arthritis before age 16.
For all sub-studies:
- History of any significant drug allergy
- Active infection, significant concurrent medical condition, or clinically
significant abnormalities
Please, be referred to the Protocol document for a complete list of
Exclusion criteria.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

SLE Sub-protocol: Systemic Lupus Erythematosus pSS Sub-protocol: Primary Sjögren’s Syndrome RA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Name: Branebrutinib
Product Code: BMS-986195
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Branebrutinib
CAS Number: 1912445-55-6
Current Sponsor code: BMS-986195
Other descriptive name: BMS986195
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Current Sponsor code: BMS-188667
Other descriptive name: ORENCIA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 125-

Primary Outcome(s)

Main Objective: SLE Sub-protocol:
-To compare the efficacy of branebrutinib with PBO at Week 24 in the treatment of subjects with SLE

pSS Sub-protocol:
-To compare the efficacy of branebrutinib with PBO at Week 24 in the treatment of subjects with pSS

RA Sub-protocol:
-To compare the efficacy of branebrutinib with PBO at Week 12 in the treatment of subjects with moderate to severe RA on a stable background of MTX who have had an inadequate response to MTX

Secondary Objective: SLE Sub-protocol:
-To compare the efficacy of branebrutinib with PBO at Week 24 in the treatment of subjects with SLE
-To compare the efficacy of branebrutinib with PBO on measures of global and organ-specific clinical responses at Week 24 in the treatment of subjects with SLE
-To compare the safety and tolerability of branebrutinib with PBO in subjects with SLE

pSS Sub-protocol:
-To compare the efficacy of branebrutinib with PBO at Week 24 in the treatment of subjects with pSS

RA Sub-protocol:
-To compare the efficacy of branebrutinib with PBO at Week 12 in the treatment of subjects with moderate to severe RA on a stable background of MTX who have had an inadequate response to MTX
-To evaluate the safety and tolerability at Week 24 of switching at Week 12 from branebrutinib or PBO to abatacept in subjects with RA.

Timepoint(s) of evaluation of this end point: SLE Sub-Protocol:
-Week 20 and Week 24
pSS Sub-Protocol:
- Week 24
RA Sub-protocol:
-Week 12

Primary end point(s): 1. SLE: mCLASI activity score response [ Time Frame: at 24 weeks ]
Proportion of participants with a = 50% reduction of mCLASI from
baseline
2. pSS: Proportion of subjects with changes in a composite score that
includes ESSPRI (EULAR Sjögren's Syndrome Patient Reported Index),
ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index), ocular
staining, salivary flow and serological marker [ Time Frame: at 24 weeks]
Clinically significant improvements from baseline in ESSPRI, ESSDAI,
ocular staining, salivary flow, and serological marker (rheumatoid factor [RF], IgG, complement C3 or C4, cryoglobulin) used in the composite measure.
3. RA: ACR50 response [ Time Frame: at 12 weeks ]
Proportion of participants achieving ACR50 response (American College of Rheumatology 50 criteria)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: SLE Sub-protocol:
-Week 24

pSS Sub-protocol:
-Week 24

RA Sub-protocol:
-Week 12

Secondary end point(s): 1. SLE: SLEDAI-2K score response [ Time Frame: at 24 weeks ]
Change from baseline in SLEDAI-2K score (Systemic Lupus
Erythematosus Disease Activity Index 2000)
2. SLE: BILAG-based Composite Lupus Assessment response [ Time
Frame: at 24 weeks ]
Change from baseline in BILAG-based (British Isles Lupus Assessment
Group) Composite Lupus Assessment response
3. RA: DAS28-CRP response [ Time Frame: at 12 weeks ]
Change from baseline in DAS28-CRP (Disease Activity Score 28 - C
reactive protein)
4. RA: DAS28-ESR response [ Time Frame: at 12 weeks ]
Change from baseline in DAS28-ESR (Disease Activity Score 28 -
Erythrocyte Sedimentation Rate)
5. RA: SDAI response [ Time Frame: at 12 weeks ]
Change from baseline in SDAI (Simplified Disease Activity Index)
6. RA: CDAI response [ Time Frame: at 12 weeks ]
Change from baseline in CDAI (Clinical Disease Activity Index)
7. RA: ACR20 response [ Time Frame: at 12 weeks ]
Proportion of participants achieving ACR20 response (American College
of Rheumatology 20 criteria)
8. RA: ACR70 response [ Time Frame: at 12 weeks ]
Proportion of participants achieving ACR70 response (American College of Rheumatology 70 criteria)
9. SLE, pSS, RA: Safety [ Time Frame: up to 28 weeks ]
Incidence of Serious Adverse Events, Adverse Events; number of
clinically significant changes in lab assessment of blood, number of
clinically significant changes in vital sign of body temperature, blood
pressure, and respiratory rate; number of clinically significant changes in electrocardiogram.

Secondary ID(s)

IM014-029

142401

2019-002205-22-GB

Source(s) of Monetary Support

Bristol-Myers Squibb Research and Development

Ethics review

Status: Approved
Approval date: 21/02/2020
Contact: