Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04895696
Registration number
NCT04895696
Ethics application status
Date submitted
19/05/2021
Date registered
20/05/2021
Date last updated
13/05/2024
Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2023-504320-25-00
Query!
Secondary ID [2]
0
0
IM026-024
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus
0
0
Query!
Condition category
Condition code
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Afimetoran
Other interventions - Placebo
Experimental: Afimetoran: Dose 1 -
Experimental: Afimetoran: Dose 2 -
Experimental: Afimetoran: Dose 3 -
Placebo Comparator: Placebo -
Treatment: Drugs: Afimetoran
Specified dose on specified days
Other interventions: Placebo
Specified dose on specified days
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Up to 48 Weeks
Query!
Secondary outcome [1]
0
0
Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) response at Week 24 and Week 48
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Up to 48 Weeks
Query!
Secondary outcome [2]
0
0
Proportion of participants who achieve an SRI(4) response at Week 24
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Up to 24 Weeks
Query!
Secondary outcome [3]
0
0
Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Up to 48 Weeks
Query!
Secondary outcome [4]
0
0
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
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Up to 48 Weeks
Query!
Secondary outcome [5]
0
0
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
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Up to 48 Weeks
Query!
Secondary outcome [6]
0
0
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
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Up to 48 Weeks
Query!
Secondary outcome [7]
0
0
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
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Up to 48 Weeks
Query!
Secondary outcome [8]
0
0
Change from baseline in PGA score of disease activity at Week 24 and Week 48
Query!
Assessment method [8]
0
0
PGA = Physician Global Assessment of disease activity (score of "0" indicating no disease activity and higher scores indicating higher disease activity)
Query!
Timepoint [8]
0
0
Up to 48 Weeks
Query!
Secondary outcome [9]
0
0
Proportion of participants who achieve CS reduction or maintenance to = 7.5 mg per day at Week 48
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Up to 48 Weeks
Query!
Secondary outcome [10]
0
0
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)
Query!
Assessment method [10]
0
0
The SF-36 was designed as an indicator of health status in population surveys, and health policy evaluations, and for use as an outcome measure in clinical practice and research. Scores for each domain range from 0 to 100, with high scores indicating a better health status.
Query!
Timepoint [10]
0
0
Up to 48 Weeks
Query!
Secondary outcome [11]
0
0
Number of participants with Adverse Events (AEs)
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Up to 100 Weeks
Query!
Secondary outcome [12]
0
0
Number of participants with Serious Adverse Events (SAEs)
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
Up to 100 Weeks
Query!
Secondary outcome [13]
0
0
Number of participants with clinical laboratory abnormalities
Query!
Assessment method [13]
0
0
Query!
Timepoint [13]
0
0
Up to 100 Weeks
Query!
Secondary outcome [14]
0
0
Number of participants with physical examination abnormalities
Query!
Assessment method [14]
0
0
Query!
Timepoint [14]
0
0
Up to 100 Weeks
Query!
Secondary outcome [15]
0
0
Number of participants with vital sign abnormalities
Query!
Assessment method [15]
0
0
Query!
Timepoint [15]
0
0
Up to 100 Weeks
Query!
Secondary outcome [16]
0
0
Number of participants with electrocardiogram (ECG) abnormalities
Query!
Assessment method [16]
0
0
Query!
Timepoint [16]
0
0
Up to 52 Weeks
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/10/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
22/04/2029
Query!
Actual
Query!
Sample size
Target
268
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Local Institution - 0063 - Botany
Query!
Recruitment hospital [2]
0
0
Westmead Hospital-Department of Clinical Immunology and Allergy - Westmead
Query!
Recruitment hospital [3]
0
0
Local Institution - 0066 - Maroochydore
Query!
Recruitment hospital [4]
0
0
Local Institution - 0065 - Woodville
Query!
Recruitment hospital [5]
0
0
Local Institution - 0062 - Camberwell
Query!
Recruitment hospital [6]
0
0
Local Institution - 0064 - Ivanhoe
Query!
Recruitment postcode(s) [1]
0
0
2019 - Botany
Query!
Recruitment postcode(s) [2]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [3]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [4]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [5]
0
0
3124 - Camberwell
Query!
Recruitment postcode(s) [6]
0
0
3079 - Ivanhoe
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kentucky
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Louisiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Missouri
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Nevada
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New York
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
North Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Ohio
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Oklahoma
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Tennessee
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
Argentina
Query!
State/province [21]
0
0
Buenos Aires
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Cordoba
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Distrito Federal
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
Tucuman
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
San Juan
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Bahia
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Mato Grosso
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Minas Gerais
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Parana
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
RIO Grande DO SUL
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
SAO Paulo
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
São Paulo
Query!
Country [33]
0
0
Chile
Query!
State/province [33]
0
0
LOS Lagos
Query!
Country [34]
0
0
Chile
Query!
State/province [34]
0
0
Los Rios
Query!
Country [35]
0
0
Chile
Query!
State/province [35]
0
0
Metropolitana
Query!
Country [36]
0
0
Chile
Query!
State/province [36]
0
0
Región Metropolitana De Santiago
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Beijing
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Guangdong
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Hebei
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Jiangsu
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Jilin
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Liaoning
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Shandong
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Shanxi
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Yunnan
Query!
Country [46]
0
0
Colombia
Query!
State/province [46]
0
0
Antioquia
Query!
Country [47]
0
0
Colombia
Query!
State/province [47]
0
0
Valle Del Cauca
Query!
Country [48]
0
0
Colombia
Query!
State/province [48]
0
0
Barranquilla
Query!
Country [49]
0
0
Colombia
Query!
State/province [49]
0
0
Bogotá
Query!
Country [50]
0
0
Colombia
Query!
State/province [50]
0
0
Cali
Query!
Country [51]
0
0
Colombia
Query!
State/province [51]
0
0
Chía
Query!
Country [52]
0
0
Colombia
Query!
State/province [52]
0
0
Zipaquira
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Aquitaine
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Finistère
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Bordeaux
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Caen
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Lille Cedex
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Marseille
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Strasbourg
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Nordrhein-Westfalen
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Berlin
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Essen
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Freiburg
Query!
Country [64]
0
0
India
Query!
State/province [64]
0
0
Delhi
Query!
Country [65]
0
0
India
Query!
State/province [65]
0
0
Haryana
Query!
Country [66]
0
0
India
Query!
State/province [66]
0
0
Karnataka
Query!
Country [67]
0
0
India
Query!
State/province [67]
0
0
Telangana
Query!
Country [68]
0
0
Ireland
Query!
State/province [68]
0
0
Leitrim
Query!
Country [69]
0
0
Ireland
Query!
State/province [69]
0
0
Dublin
Query!
Country [70]
0
0
Ireland
Query!
State/province [70]
0
0
Galway
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Fukui
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Fukuoka
Query!
Country [73]
0
0
Japan
Query!
State/province [73]
0
0
Hokkaido
Query!
Country [74]
0
0
Japan
Query!
State/province [74]
0
0
Ishikawa
Query!
Country [75]
0
0
Japan
Query!
State/province [75]
0
0
Miyagi
Query!
Country [76]
0
0
Japan
Query!
State/province [76]
0
0
Tokyo
Query!
Country [77]
0
0
Japan
Query!
State/province [77]
0
0
Aichi
Query!
Country [78]
0
0
Japan
Query!
State/province [78]
0
0
Chiba
Query!
Country [79]
0
0
Japan
Query!
State/province [79]
0
0
Fukushima
Query!
Country [80]
0
0
Mexico
Query!
State/province [80]
0
0
Distrito Federal
Query!
Country [81]
0
0
Mexico
Query!
State/province [81]
0
0
Guanajuato
Query!
Country [82]
0
0
Mexico
Query!
State/province [82]
0
0
Jalisco
Query!
Country [83]
0
0
Mexico
Query!
State/province [83]
0
0
Nuevo LEON
Query!
Country [84]
0
0
Mexico
Query!
State/province [84]
0
0
Chihuahua
Query!
Country [85]
0
0
Mexico
Query!
State/province [85]
0
0
Merida
Query!
Country [86]
0
0
Poland
Query!
State/province [86]
0
0
Mazowieckie
Query!
Country [87]
0
0
Poland
Query!
State/province [87]
0
0
Podlaskie
Query!
Country [88]
0
0
Poland
Query!
State/province [88]
0
0
Bydgoszcz
Query!
Country [89]
0
0
Poland
Query!
State/province [89]
0
0
Poznan
Query!
Country [90]
0
0
Poland
Query!
State/province [90]
0
0
Rzeszów
Query!
Country [91]
0
0
Poland
Query!
State/province [91]
0
0
Sosnowiec
Query!
Country [92]
0
0
Poland
Query!
State/province [92]
0
0
Warszawa
Query!
Country [93]
0
0
Poland
Query!
State/province [93]
0
0
Wroclaw
Query!
Country [94]
0
0
Puerto Rico
Query!
State/province [94]
0
0
San Juan
Query!
Country [95]
0
0
Romania
Query!
State/province [95]
0
0
Bucharest
Query!
Country [96]
0
0
Romania
Query!
State/province [96]
0
0
Giroc
Query!
Country [97]
0
0
Romania
Query!
State/province [97]
0
0
Râmnicu Vâlcea
Query!
Country [98]
0
0
Spain
Query!
State/province [98]
0
0
Cantabria
Query!
Country [99]
0
0
Spain
Query!
State/province [99]
0
0
A Coruña
Query!
Country [100]
0
0
Spain
Query!
State/province [100]
0
0
Barcelona
Query!
Country [101]
0
0
Spain
Query!
State/province [101]
0
0
Madrid
Query!
Country [102]
0
0
Spain
Query!
State/province [102]
0
0
Sevilla
Query!
Country [103]
0
0
Taiwan
Query!
State/province [103]
0
0
Kaohsiung Niao Sung Dist
Query!
Country [104]
0
0
Taiwan
Query!
State/province [104]
0
0
Taichung
Query!
Country [105]
0
0
Taiwan
Query!
State/province [105]
0
0
Taipei
Query!
Country [106]
0
0
United Kingdom
Query!
State/province [106]
0
0
Cambridgeshire
Query!
Country [107]
0
0
United Kingdom
Query!
State/province [107]
0
0
Bradford
Query!
Country [108]
0
0
United Kingdom
Query!
State/province [108]
0
0
Edinburgh
Query!
Country [109]
0
0
United Kingdom
Query!
State/province [109]
0
0
Manchester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04895696
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
855-907-3286
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04895696
Download to PDF