Clinical trial NCT04895696: A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: BMS-986256
Systemic Lupus Erythematosus
SLE
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Afimetoran
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.


Eligibility criteria: Inclusion Criteria:

* Diagnosed ≥ 12 weeks before the screening visit and qualify as having SLE according to the SLE International Collaborating Clinics (SLICC) Classification Criteria at the screening visit
* Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody ≥ 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody.
* Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score ≥ 6 points and clinical Hybrid SLEDAI score ≥ 4 points with joint involvement and/or rash

Exclusion Criteria:

* Active severe lupus nephritis (LN) as assessed by the investigator
* Active or unstable neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI
* Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE
* Antiphospholipid Syndrome

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48
timeFrame: Up to 48 Weeks
Secondary outcomes:
measure: Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) response at Week 24 and Week 48
timeFrame: Up to 48 Weeks
measure: Proportion of participants who achieve an SRI(4) response at Week 24
timeFrame: Up to 24 Weeks
measure: Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48
timeFrame: Up to 48 Weeks
measure: Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index; Activity (CLASI-A) score ≥ 10 at baseline who achieve a decrease of ≥ 50% from baseline CLASI-A score (CLASI-50) response at Week 24 and Week 48
timeFrame: Up to 48 Weeks
measure: Proportion of participants with 6 or more swollen joints and 6 or more tender joints at baseline who achieve a ≥ 50% reduction from baseline in both swollen and tender joints at Week 24 and Week 48
timeFrame: Up to 48 Weeks
measure: Mean change from baseline in swollen joint count using the 28-joint count at Week 24 and Week 48 in participants with ≥ 2 swollen joints at baseline
timeFrame: Up to 48 Weeks
measure: Mean change from baseline in tender joint count at Week 24 and Week 48 using the 28- joint count in participants with ≥ 2 tender joints at baseline
timeFrame: Up to 48 Weeks
measure: Change from baseline in PGA score of disease activity at Week 24 and Week 48
timeFrame: Up to 48 Weeks
measure: Proportion of participants who achieve CS reduction or maintenance to ≤ 7.5 mg per day at Week 48
timeFrame: Up to 48 Weeks
measure: Change in participant reported disease activity from baseline to Week 24 and Week 48 according to the 36-item Short Form Health Questionnaire (SF-36)
timeFrame: Up to 48 Weeks
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 100 Weeks
measure: Number of participants with Serious Adverse Events (SAEs)
timeFrame: Up to 100 Weeks
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 100 Weeks
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 100 Weeks
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 100 Weeks
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 52 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0100
state: Alabama
city: Huntington Beach
country: United States
facility: Local Institution - 0123
state: California
city: La Jolla
country: United States
facility: Local Institution - 0170
state: California
city: La Palma
country: United States
facility: Local Institution - 0159
state: California
city: San Diego
country: United States
facility: Local Institution - 0172
state: California
city: Woodland Hills
country: United States
facility: Local Institution - 0164
state: California
city: Clearwater
country: United States
facility: Local Institution - 0121
state: Florida
city: Kissimmee
country: United States
facility: Local Institution - 0167
state: Florida
city: Orlando
country: United States
facility: Local Institution - 0122
state: Florida
city: Ormond Beach
country: United States
facility: Local Institution - 0173
state: Florida
city: Plantation
country: United States
facility: Local Institution - 0154
state: Florida
city: South Miami
country: United States
facility: Local Institution - 0137
state: Florida
city: Tamarac
country: United States
facility: Local Institution - 0155
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0160
state: Georgia
city: Suwanee
country: United States
facility: Local Institution - 0205
state: Georgia
city: Orland Park
country: United States
facility: Local Institution - 0146
state: Illinois
city: Hopkinsville
country: United States
facility: Local Institution - 0187
state: Kentucky
city: Baton Rouge
country: United States
facility: Local Institution - 0171
state: Louisiana
city: Wheaton
country: United States
facility: Local Institution - 0134
state: Maryland
city: Eagan
country: United States
facility: Local Institution - 0070
state: Minnesota
city: Saint Louis
country: United States
facility: Local Institution - 0124
state: Missouri
city: Saint Louis
country: United States
facility: Local Institution - 0165
state: Missouri
city: Las Vegas
country: United States
facility: Local Institution - 0091
state: Nevada
city: West Long Branch
country: United States
facility: Local Institution - 0219
state: New Jersey
city: Bronx
country: United States
facility: Local Institution - 0132
state: New York
city: Manhasset
country: United States
facility: Local Institution - 0140
state: New York
city: Charlotte
country: United States
facility: Local Institution - 0203
state: North Carolina
city: Charlotte
country: United States
facility: Local Institution - 0103
state: North Carolina
city: Columbus
country: United States
facility: Local Institution - 0151
state: Ohio
city: Middleburg Heights
country: United States
facility: Local Institution - 0042
state: Ohio
city: Allen
country: United States
facility: Local Institution - 0152
state: Texas
city: Allen
country: United States
facility: Local Institution - 0197
state: Texas
city: Amarillo
country: United States
facility: Local Institution - 0136
state: Texas
city: Mesquite
country: United States
facility: Local Institution - 0029
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0163
state: Texas
city: Bellevue
country: United States
facility: Local Institution - 0223
state: Washington
city: Quilmes
country: Argentina
facility: Local Institution - 0130
state: Buenos Aires
city: San Fernando
country: Argentina
facility: Local Institution - 0195
state: Buenos Aires
city: Córdoba
country: Argentina
facility: Local Institution - 0025
state: Cordoba
city: Buenos Aires
country: Argentina
facility: Local Institution - 0074
state: Distrito Federal
city: Caba
country: Argentina
facility: Local Institution - 0040
state: Distrito Federal
city: San Miguel de Tucumán
country: Argentina
facility: Local Institution - 0027
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Local Institution - 0207
city: Buenos Aires
country: Argentina
facility: Local Institution - 0128
city: San Juan
country: Argentina
facility: Local Institution - 0041
city: Botany
country: Australia
facility: Local Institution - 0063
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution - 0072
state: New South Wales
city: Maroochydore
country: Australia
facility: Local Institution - 0066
state: Queensland
city: Woodville
country: Australia
facility: Local Institution - 0065
state: South Australia
city: Camberwell
country: Australia
facility: Local Institution - 0062
state: Victoria
city: Ivanhoe
country: Australia
facility: Local Institution - 0064
state: Victoria
city: Salvador
country: Brazil
facility: Local Institution - 0006
state: Bahia
city: Salvador
country: Brazil
facility: Local Institution - 0031
state: Bahia
city: Cuiabá
country: Brazil
facility: Local Institution - 0093
state: Mato Grosso
city: Juiz de Fora
country: Brazil
facility: Local Institution - 0008
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Local Institution - 0010
state: Parana
city: Porto Alegre
country: Brazil
facility: Local Institution - 0007
state: RIO Grande DO SUL
city: São Bernardo do Campo
country: Brazil
facility: Local Institution - 0014
state: SAO Paulo
city: São José do Rio Preto
country: Brazil
facility: Local Institution - 0045
state: São Paulo
city: São Paulo
country: Brazil
facility: Local Institution - 0009
city: Osorno
country: Chile
facility: Local Institution - 0127
state: LOS Lagos
city: Valdivia
country: Chile
facility: Local Institution - 0143
state: Los Rios
city: Santiago
country: Chile
facility: Local Institution - 0073
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0043
state: Metropolitana
city: Providencia
country: Chile
facility: Local Institution - 0075
state: Región Metropolitana De Santiago
city: Beijing
country: China
facility: Local Institution - 0177
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0180
state: Beijing
city: Shenzhen
country: China
facility: Local Institution - 0184
state: Guangdong
city: Nanjing
country: China
facility: Local Institution - 0176
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution - 0188
state: Jiangsu
city: Suzhou
country: China
facility: Local Institution - 0193
state: Jiangsu
city: Changchun
country: China
facility: Local Institution - 0174
state: Jilin
city: Dalian
country: China
facility: Local Institution - 0179
state: Liaoning
city: Jinan
country: China
facility: Local Institution - 0178
state: Shandong
city: Jining
country: China
facility: Local Institution - 0183
state: Shandong
city: Medellín
country: Colombia
facility: Local Institution - 0190
state: Antioquia
city: Barranquilla
country: Colombia
facility: Local Institution - 0001
city: Bogotá
country: Colombia
facility: Local Institution - 0004
city: Cali
country: Colombia
facility: Local Institution - 0076
city: Chía
country: Colombia
facility: Local Institution - 0005
city: Zipaquira
country: Colombia
facility: Local Institution - 0003
city: Pessac
country: France
facility: Local Institution - 0156
state: Aquitaine
city: Brest
country: France
facility: Local Institution - 0083
state: Finistère
city: Bordeaux
country: France
facility: Local Institution - 0048
city: Caen
country: France
facility: Local Institution - 0144
city: Lille Cedex
country: France
facility: Local Institution - 0129
city: Marseille
country: France
facility: Local Institution - 0112
city: Strasbourg
country: France
facility: Local Institution - 0044
city: Köln
country: Germany
facility: Local Institution - 0087
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Local Institution - 0085
city: Essen
country: Germany
facility: Local Institution - 0086
city: Freiburg
country: Germany
facility: Local Institution - 0084
city: New Delhi
country: India
facility: Local Institution - 0208
state: Delhi
city: Ahmedabad
country: India
facility: Local Institution - 0226
state: Gujarat
city: Gurugram
country: India
facility: Local Institution - 0214
state: Haryana
city: Bengaluru
country: India
facility: Local Institution - 0210
state: Karnataka
city: Secunderabad
country: India
facility: Local Institution - 0209
state: Telangana
city: Manorhamilton
country: Ireland
facility: Local Institution - 0119
state: Leitrim
city: Dublin
country: Ireland
facility: Local Institution - 0106
city: Galway
country: Ireland
facility: Local Institution - 0107
city: Eiheiji-cho,Yoshida-gun
country: Japan
facility: Local Institution - 0114
state: Fukui
city: Kitakyushu
country: Japan
facility: Local Institution - 0095
state: Fukuoka
city: Sapporo
country: Japan
facility: Local Institution - 0096
state: Hokkaido
city: Kanazawa
country: Japan
facility: Local Institution - 0104
state: Ishikawa
city: Sendai-shi
country: Japan
facility: Local Institution - 0099
state: Miyagi
city: Bunkyo-ku
country: Japan
facility: Local Institution - 0117
state: Tokyo
city: Fuchu
country: Japan
facility: Local Institution - 0218
state: Tokyo
city: Itabashiku
country: Japan
facility: Local Institution - 0113
state: Tokyo
city: Meguro-ku
country: Japan
facility: Local Institution - 0150
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution - 0098
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution - 0105
state: Tokyo
city: Aichi
country: Japan
facility: Local Institution - 0138
city: Chiba
country: Japan
facility: Local Institution - 0115
city: Fukushima
country: Japan
facility: Local Institution - 0162
city: Tokyo
country: Japan
facility: Local Institution - 0097
city: Tokyo
country: Japan
facility: Local Institution - 0116
city: Mexico City
country: Mexico
facility: Local Institution - 0060
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Local Institution - 0018
state: Distrito Federal
city: Leon
country: Mexico
facility: Local Institution - 0020
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Local Institution - 0017
state: Jalisco
city: Zapopan
country: Mexico
facility: Local Institution - 0022
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution - 0071
state: Nuevo LEON
city: Chihuahua
country: Mexico
facility: Local Institution - 0021
city: Merida
country: Mexico
facility: Local Institution - 0061
city: Mexico City
country: Mexico
facility: Local Institution - 0158
city: Warszawa
country: Poland
facility: Local Institution - 0204
state: Mazowieckie
city: Poznan
country: Poland
facility: Local Institution - 0049
city: Warszawa
country: Poland
facility: Local Institution - 0149
city: Wrocław
country: Poland
facility: Local Institution - 0052
city: San Juan
country: Puerto Rico
facility: Local Institution - 0037
city: Râmnicu Vâlcea
country: Romania
facility: Local Institution - 0082
state: Vâlcea
city: Bucharest
country: Romania
facility: Local Institution - 0157
city: Bucharest
country: Romania
facility: Local Institution - 0067
city: Giroc
country: Romania
facility: Local Institution - 0068
city: Santander
country: Spain
facility: Local Institution - 0206
state: Cantabria
city: A Coruña
country: Spain
facility: Local Institution - 0056
city: Barcelona
country: Spain
facility: Local Institution - 0058
city: Madrid
country: Spain
facility: Local Institution - 0055
city: Sevilla
country: Spain
facility: Local Institution - 0057
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Local Institution - 0080
city: Taichung
country: Taiwan
facility: Local Institution - 0081
city: Taichung
country: Taiwan
facility: Local Institution - 0078
city: Taipei
country: Taiwan
facility: Local Institution - 0079
city: Taipei
country: Taiwan
facility: Local Institution - 0077
city: Cambridge
country: United Kingdom
facility: Local Institution - 0111
state: Cambridgeshire
city: Bradford
country: United Kingdom
facility: Local Institution - 0110
city: Manchester
country: United Kingdom
facility: Local Institution - 0125
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: