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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 (AMETHYST LTE)

Primary Purpose

Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

Status
Enrolling by invitation
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BIIB059 (litifilimab)
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacute Cutaneous Lupus Erythematosus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • David Fivenson, MD, Dermatology, PLLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIIB059

Arm Description

Participants will receive BIIB059 subcutaneously, once every 4 weeks up to Week 100.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Secondary Outcome Measures

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 ≥ 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 Parent Study (NCT05531565)
Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score From the Baseline (Parent Study [NCT05531565]) to Week 104
Percent Change in CLASI-D Score From the Baseline (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 From Baseline Value (Parent Study [NCT05531565]) Through Week 52
Annualized Mild/Moderate and Severe SFI Rates From Baseline Value (Parent Study [NCT05531565]) Through Week 104
Percentage of Participants With Oral Corticosteroid (OCS) Dose
Percentage of Participants With OCS ≤ 7.5 Milligrams per day (mg/day)
Percentage of Participants With OCS ≤ 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
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 ECG Results
Number of Participants With Anti-BIIB059 Antibodies in Serum
Serum Concentration of Litifilimab

Full Information

First Posted
August 23, 2023
Last Updated
October 6, 2023
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT06044337
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 3, 2023 (Actual)
Primary Completion Date
June 26, 2029 (Anticipated)
Study Completion Date
December 11, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
322 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BIIB059
Arm Type
Experimental
Arm Description
Participants will receive BIIB059 subcutaneously, once every 4 weeks up to Week 100.
Intervention Type
Drug
Intervention Name(s)
BIIB059 (litifilimab)
Other Intervention Name(s)
litifilimab
Intervention Description
Administered as specified in the treatment arm.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame
Up to 128 weeks
Secondary Outcome Measure Information:
Title
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])
Time Frame
Up to 128 weeks
Title
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])
Time Frame
Up to 128 weeks
Title
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])
Time Frame
Up to 128 weeks
Title
Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1
Time Frame
Up to 128 weeks
Title
Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1
Time Frame
Up to 128 weeks
Title
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])
Time Frame
Up to 128 weeks
Title
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])
Time Frame
Up to 128 weeks
Title
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])
Time Frame
Up to 128 weeks
Title
Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R Erythema Score of 0 or 1
Time Frame
Up to 128 weeks
Title
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])
Time Frame
Up to 128 weeks
Title
Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R Follicular Activity Score of 0
Time Frame
Up to 128 weeks
Title
Percentage of Participants With a CLASI-70 Response Among CLASI-70 Responders at Week 52 of the Parent Study (NCT05531565)
Time Frame
Day 0 (Week 52 of parent study) up to 128 weeks
Title
Percentage of Participants With a CLASI-50 Response Among CLASI-50 Responders at Week 52 of the Parent Study (NCT05531565)
Time Frame
Day 0 (Week 52 of parent study) up to 128 weeks
Title
Percentage of Participants With a CLASI-90 Response Among CLASI-90 Responders at Week 52 of the Parent Study (NCT05531565)
Time Frame
Day 0 (Week 52 of parent study) up to 128 weeks
Title
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)
Time Frame
Day 0 (Week 52 of parent study) up to 128 weeks
Title
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)
Time Frame
Day 0 (Week 52 of parent study) up to 128 weeks
Title
Percentage of Participants With a CLASI-70 Response Among CLASI-50 Responders at Week 52 of the Parent Study (NCT05531565)
Time Frame
Day 0 (Week 52 of parent study) up to 128 weeks
Title
Percentage of Participants With a CLASI-90 Response Among CLASI-50 Responders at Week 52 of the Parent Study (NCT05531565)
Time Frame
Day 0 (Week 52 of parent study) up to 128 weeks
Title
Percentage of Participants With a CLASI-90 Response Among CLASI-70 Responders at Week 52 of the Parent Study (NCT05531565)
Time Frame
Day 0 (Week 52 of parent study) up to 128 weeks
Title
Percentage of Participants With Loss of Response, Defined as an Increase of ≥ 7 Points in CLASI-A Total Score From Baseline
Time Frame
Baseline (Day 0) up to 128 weeks
Title
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)
Time Frame
Up to 128 weeks
Title
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)
Time Frame
Up to 128 weeks
Title
Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score From the Baseline (Parent Study [NCT05531565]) to Week 104
Time Frame
Up to 104 weeks
Title
Percent Change in CLASI-D Score From the Baseline (Parent Study [NCT05531565]) to Week 104
Time Frame
Up to 104 weeks
Title
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
Time Frame
Up to 52 weeks
Title
Annualized Mild/Moderate and Severe SFI Rates From Baseline Value (Parent Study [NCT05531565]) Through Week 104
Time Frame
Up to 104 weeks
Title
Percentage of Participants With Oral Corticosteroid (OCS) Dose
Time Frame
Up to 104 weeks
Title
Percentage of Participants With OCS ≤ 7.5 Milligrams per day (mg/day)
Time Frame
Up to 104 weeks
Title
Percentage of Participants With OCS ≤ 5.0 mg/day
Time Frame
Up to 104 weeks
Title
Change From Baseline Value (Parent Study [NCT05531565]) in Cutaneous Lupus Erythematosus - Quality of Life (CLE-QoL) at Weeks 52 and 104
Time Frame
Baseline, Weeks 52 and 104
Title
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
Time Frame
Baseline, Weeks 52 and 104
Title
Change From Baseline Value (Parent Study [NCT05531565]) in 36-Item Short Form Survey (SF-36) (acute version) at Weeks 52 and 104
Time Frame
Baseline, Weeks 52 and 104
Title
Change From Baseline Value (Parent Study [NCT05531565]) in Work Productivity and Activity Impairment (WPAI): Lupus at Weeks 52 and 104
Time Frame
Baseline, Weeks 52 and 104
Title
Change From Baseline Value (Parent Study [NCT05531565]) in Patient Health Questionnaire-9 (PHQ-9) at Weeks 52 and 104
Time Frame
Baseline, Weeks 52 and 104
Title
Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in Standard Laboratory Parameters
Time Frame
Up to 128 weeks
Title
Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in ECG Results
Time Frame
Up to 104 weeks
Title
Number of Participants With Anti-BIIB059 Antibodies in Serum
Time Frame
Up to 128 weeks
Title
Serum Concentration of Litifilimab
Time Frame
Pre-dose up to 128 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
David Fivenson, MD, Dermatology, PLLC
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
IPD Sharing URL
https://vivli.org/

Learn more about this trial

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

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