A Multicenter, Open-Label, Single-Arm, Phase 3, Long-Term Extension
Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adult Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST LTE)
Phase 3 Long-term Extension Study to Evaluate BIIB059 in Active CLE
Matsuda Naoto
Biogen Japan Ltd.
Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027
+81-120-560-086
japan-medinfo@biogen.com
Biogen Japan Medical Information
Biogen Japan Ltd.
Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027
+81-120-560-086
japan-medinfo@biogen.com
Recruiting
Nov. 27, 2024
Nov. 26, 2024
322
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
Participants who completed the parent study (Study 230LE301, Part A or Part B) on
study treatment (received treatment through Week 48 and attended the last study
assessment visit at Week 52)
1. Early Part A or Part B parent study treatment terminators (participants who discontinued
study treatment before Week 48).
2. Early Part A or Part B parent study terminators (participants who withdrew from parent
study participation before Week 52 and did not complete the parent study ETP).
3. Participants who have developed any other medical diseases, conditions, or
abnormalities, rendering their participation in the LTE study unsuitable in the opinion of
the Investigator.
NOTE: Other protocol defined Exclusion criteria may apply.
18age old over
No limit
Both
Active Subacute Cutaneous Lupus Erythematosus /Chronic Cutaneous Lupus Erythematosus(CCLE)
Research Name: BIIB059
Generic Name: litifilimab
Trade Names: Not applicable
Participants will receive BIIB059 subcutaneously, once every 4 weeks up to Week 100.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Percentage of Participants who Achieve a Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI)-70 Response, Defined as a 70% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])
Percentage of Participants who Achieve a CLASI-50 Response, Defined as a 50% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])
Percentage of Participants who Achieve a CLASI-90 Response, Defined as a 90% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])
Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1
Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1
Cumulative Duration of Sustained CLASI-70 Response, Defined as the Number of Weeks With 70% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])
Cumulative Duration of Sustained CLASI-50 Response, Defined as the Number of Weeks With 50% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])
Cumulative Duration of Sustained CLASI-90 Response, Defined as the Number of Weeks With 90% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])
Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R Erythema Score of 0 or 1
Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R OMC Score of 0 or 1 and Improvement of at Least 1 Point From Baseline Value (Parent Study [NCT05531565])
Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R Follicular Activity Score of 0
Percentage of Participants With a CLASI-70 Response Among CLASI-70 Responders at Week 52 of the Parent Study (NCT05531565)
Percentage of Participants With a CLASI-50 Response Among CLASI-50 Responders at Week 52 of the Parent Study (NCT05531565)
Percentage of Participants With a CLASI-90 Response Among CLASI-90 Responders at Week 52 of the Parent Study (NCT05531565)
Percentage of Participants With a CLA-IGA-R Erythema Score of 0 or 1 Among Participants With a CLA-IGA-R Erythema Score of 0 or 1 at Week 52 of the Parent Study (NCT05531565)
Percentage of Participants With CLA-IGA-R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline Value(Parent Study) Among Participants With CLA IGA R OMC Score of 0 or 1 and at Least 1 Level Improvement From Baseline Value(Parent Study)
Percentage of Participants With a CLASI-70 Response Among CLASI-50 Responders at Week 52 of the Parent Study (NCT05531565)
Percentage of Participants With a CLASI-90 Response Among CLASI-50 Responders at Week 52 of the Parent Study (NCT05531565)
Percentage of Participants With a CLASI-90 Response Among CLASI-70 Responders at Week 52 of the Parent Study (NCT05531565)
Percentage of Participants With Loss of Response, Defined as an Increase of greater than or equal to 7 Points in CLASI-A Total Score From Baseline
Percentage of Participants With Loss of Response, Defined as Achieving 2 Points Improvement From Baseline Value(Parent Study) CLA-IGA-R Erythema Score at Beginning of/During LTE Study and Then Relapsing to CLA-IGA-R Erythema Baseline Value(Parent Study)
Percentage of Participants With Loss of Response, Defined as Having at Least 2, 3, and 4 Points Worsening in CLA-IGA-R Erythema Score From Their Minimum Score in the Parent Study (NCT05531565)
Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score From Baseline Value (Parent Study [NCT05531565]) to Week 104
Percent Change in CLASI-D Score From Baseline Value (Parent Study [NCT05531565]) to Week 104
Annualized Mild/Moderate and Severe Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rates Through Week 52
Annualized Mild/Moderate and Severe SFI Rates Through Week 104
Percentage of Participants With Oral Corticosteroid (OCS) Dose
Percentage of Participants With OCS less than or equal to 7.5 Milligrams per day (mg/day)
Percentage of Participants With OCS less than or equal to 5.0 mg/day
Change From Baseline Value (Parent Study [NCT05531565]) in Cutaneous Lupus Erythematosus - Quality of Life (CLE-QoL) at Weeks 52 and 104
Change From Baseline Value (Parent Study [NCT05531565]) in European Quality of Life - 5-Dimensions Questionnaire, 3-Level Version (EQ-5D-3L) at Weeks 52 and 104
Change From Baseline Value (Parent Study [NCT05531565]) in 36-Item Short Form Survey (SF-36) (acute version) at Weeks 52 and 104
Change From Baseline Value (Parent Study [NCT05531565]) in Work Productivity and Activity Impairment (WPAI): Lupus at Weeks 52 and 104
Change From Baseline Value (Parent Study [NCT05531565]) in Patient Health Questionnaire-9 (PHQ-9) at Weeks 52 and 104
Change From Baseline Value (Parent Study [NCT05531565]) in Subject Global Assessment of Skin - Follow-up (SGA-Skin-FU) at Weeks 52 and 104
Change From Baseline Value (Parent Study [NCT05531565]) in Numerical Rating Scale (NRS) for Pain in Skin Rash at Weeks 52 and 104
Change From Baseline Value (Parent Study [NCT05531565]) in Numerical Rating Scale (NRS) for Itch in Skin Rash at Weeks 52 and 104
Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in Standard Laboratory Parameters
Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in Electrocardiogram (ECG) Results
Number of Participants With Anti-BIIB059 Antibodies in Serum
Serum Concentration of Litifilimab
Biogen Japan Ltd.
Kanazawa University Hospital IRB
13-1, Takaramachi, Kanazawa, Ishikawa
+81-76-265-2000
Approval
Sept. 11, 2024
Yes
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
