A Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adults With Active Subacute Cutaneous Lupus Erythematosus (CLE) and/or Chronic CLE With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

Subacute Cutaneous Lupus Erythematosus Clinical Trial

— AMETHYST LTE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06044337
• Other study ID #: 230LE305
• Secondary ID: 2023-504863-17-0
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: October 3, 2023
• Est. completion date: December 11, 2029

Study information

• Verified date: May 2024
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the long-term safety and tolerability BIIB059 (litifilimab) in participants who completed the parent study 230LE301 (NCT05531565) with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy.

The secondary objectives of the study are to evaluate the long-term effect of litifilimab on disease activity and the effect of litifilimab in preventing disease damage in participants with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarials; to evaluate the long-term effect of litifilimab on preventing lupus flare in participants with CLE with systemic lupus erythematosus (SLE); to assess long-term use of oral corticosteroid (OCS) in participants receiving litifilimab treatment; to assess the impact of litifilimab on participant-reported health-related quality of life (HRQoL); to evaluate long-term effect of litifilimab on laboratory parameters; to evaluate the immunogenicity and pharmacokinetics (PK) of litifilimab.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 322
• Est. completion date: December 11, 2029
• Est. primary completion date: June 26, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Participants who completed the parent study (230LE301 [NCT05531565], Part A or Part B) on study treatment (received treatment through Week 48 and attended the last study assessment visit at Week 52).

• Ability of the participant to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.

Key Exclusion Criteria:

• Early Part A or Part B parent study (230LE301 [NCT05531565]) treatment terminators (participants who discontinued study treatment before Week 48).

• 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 extended treatment period (ETP)].

• Participants who have developed any other medical diseases, conditions, or abnormalities, rendering their participation in the long-term extension (LTE) study unsuitable in the opinion of the Investigator.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Discoid
• Lupus Erythematosus, Systemic
• Subacute Cutaneous Lupus Erythematosus

Intervention

Drug:
• BIIB059 (litifilimab)
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
Chile	Clinical Research Chile SpA	Valdivia
France	Hopital Tenon	Paris
France	Hopital Larrey	Toulouse Cedex 9	Haute Garonne
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid
Sweden	Karolinska Universitetssjukhuset - Solna	Solna
Switzerland	Kantonsspital St. Gallen	St. Gallen
United States	David Fivenson, MD, Dermatology, PLLC	Ann Arbor	Michigan
United States	Precision Comprehensive Clinical Research Solutions	Grapevine	Texas
United States	Dermatology Research Associates	Los Angeles	California
United States	Revival Research Institute, LLC	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Chile,  France,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		Up to 128 weeks
Secondary	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])		Up to 128 weeks
Secondary	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])		Up to 128 weeks
Secondary	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])		Up to 128 weeks
Secondary	Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1		Up to 128 weeks
Secondary	Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1		Up to 128 weeks
Secondary	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])		Up to 128 weeks
Secondary	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])		Up to 128 weeks
Secondary	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])		Up to 128 weeks
Secondary	Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R Erythema Score of 0 or 1		Up to 128 weeks
Secondary	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])		Up to 128 weeks
Secondary	Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R Follicular Activity Score of 0		Up to 128 weeks
Secondary	Percentage of Participants With a CLASI-70 Response Among CLASI-70 Responders at Week 52 of the Parent Study (NCT05531565)		Day 0 (Week 52 of parent study) up to 128 weeks
Secondary	Percentage of Participants With a CLASI-50 Response Among CLASI-50 Responders at Week 52 of the Parent Study (NCT05531565)		Day 0 (Week 52 of parent study) up to 128 weeks
Secondary	Percentage of Participants With a CLASI-90 Response Among CLASI-90 Responders at Week 52 of the Parent Study (NCT05531565)		Day 0 (Week 52 of parent study) up to 128 weeks
Secondary	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)		Day 0 (Week 52 of parent study) up to 128 weeks
Secondary	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)		Day 0 (Week 52 of parent study) up to 128 weeks
Secondary	Percentage of Participants With a CLASI-70 Response Among CLASI-50 Responders at Week 52 of the Parent Study (NCT05531565)		Day 0 (Week 52 of parent study) up to 128 weeks
Secondary	Percentage of Participants With a CLASI-90 Response Among CLASI-50 Responders at Week 52 of the Parent Study (NCT05531565)		Day 0 (Week 52 of parent study) up to 128 weeks
Secondary	Percentage of Participants With a CLASI-90 Response Among CLASI-70 Responders at Week 52 of the Parent Study (NCT05531565)		Day 0 (Week 52 of parent study) up to 128 weeks
Secondary	Percentage of Participants With Loss of Response, Defined as an Increase of = 7 Points in CLASI-A Total Score From Baseline		Baseline (Day 0) up to 128 weeks
Secondary	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)		Up to 128 weeks
Secondary	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 Parent Study (NCT05531565)		Up to 128 weeks
Secondary	Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score From the Baseline (Parent Study [NCT05531565]) to Week 104		Up to 104 weeks
Secondary	Percent Change in CLASI-D Score From the Baseline (Parent Study [NCT05531565]) to Week 104		Up to 104 weeks
Secondary	Annualized Mild/Moderate and Severe Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rates From Baseline Value (Parent Study [NCT05531565]) Through Week 52		Up to 52 weeks
Secondary	Annualized Mild/Moderate and Severe SFI Rates From Baseline Value (Parent Study [NCT05531565]) Through Week 104		Up to 104 weeks
Secondary	Percentage of Participants With Oral Corticosteroid (OCS) Dose		Up to 104 weeks
Secondary	Percentage of Participants With OCS = 7.5 Milligrams per day (mg/day)		Up to 104 weeks
Secondary	Percentage of Participants With OCS = 5.0 mg/day		Up to 104 weeks
Secondary	Change From Baseline Value (Parent Study [NCT05531565]) in Cutaneous Lupus Erythematosus - Quality of Life (CLE-QoL) at Weeks 52 and 104		Baseline, Weeks 52 and 104
Secondary	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		Baseline, Weeks 52 and 104
Secondary	Change From Baseline Value (Parent Study [NCT05531565]) in 36-Item Short Form Survey (SF-36) (acute version) at Weeks 52 and 104		Baseline, Weeks 52 and 104
Secondary	Change From Baseline Value (Parent Study [NCT05531565]) in Work Productivity and Activity Impairment (WPAI): Lupus at Weeks 52 and 104		Baseline, Weeks 52 and 104
Secondary	Change From Baseline Value (Parent Study [NCT05531565]) in Patient Health Questionnaire-9 (PHQ-9) at Weeks 52 and 104		Baseline, Weeks 52 and 104
Secondary	Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in Standard Laboratory Parameters		Up to 128 weeks
Secondary	Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in ECG Results		Up to 104 weeks
Secondary	Number of Participants With Anti-BIIB059 Antibodies in Serum		Up to 128 weeks
Secondary	Serum Concentration of Litifilimab		Pre-dose up to 128 weeks