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临床试验/NCT06044337
NCT06044337Enrolling By Invitation3 期

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

Biogen108 个研究点 分布在 13 个国家目标入组 306 人开始时间: 2023年10月3日最近更新:
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适应症
干预措施

试验速览

阶段
3 期
状态
Enrolling By Invitation
发起方
Biogen
入组人数
306
试验地点
108
主要终点
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue.

The study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301.

The main objective of the study is to learn more about the long-term safety of litifilimab.

The main question researchers want to answer is:

  • How many participants have adverse events and serious adverse events after taking litifilimab? Adverse events are health problems that may or may not be caused by the study drug.

Researchers will also learn more about the effect of litifilimab on CLE. They will do this by measuring the symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI).

Researchers will look at how litifilimab and CLE affect the quality of life of participants using a group of questionnaires. They will also look at how litifilimab affects laboratory tests and how participants' immune systems respond to litifilimab.

The study will be done as follows:

  • The last visit of parent study 230LE301 will be the first visit of study 230LE305.
  • All participants will receive litifilimab as an injection under the skin once every 4 weeks. Both researchers and participants will know the dose and identity of the study drug.
  • Globally, the treatment period will last up to 208 weeks, or 4 years. Participants will have up to 53 study visits during this time.

详细描述

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 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

BIIB059

Experimental

Participants will receive BIIB059 (litifilimab) subcutaneously (SC), once every 4 weeks up to Week 204 in the LTE period.

干预措施: BIIB059 (litifilimab) (Drug)

结局指标

主要结局

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

时间窗: Up to 232 weeks

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

时间窗: Up to 128 weeks

次要结局

  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Change From Baseline Value (Parent Study [NCT05531565]) in Subject Global Assessment of Skin - Follow-up (SGA-Skin-FU) at Weeks 52 and 104(Baseline, 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(Baseline, 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(Baseline, Weeks 52 and 104)
  • Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in Standard Laboratory Parameters(Up to 128 weeks)
  • 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)
  • 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)
  • Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in Electrocardiogram (ECG) Results(Up to 104 weeks)
  • 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)
  • Number of Participants With Anti-BIIB059 Antibodies in Serum(Up to 128 weeks)
  • 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)
  • Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1(Up to 128 weeks)
  • 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)
  • 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)
  • 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)
  • 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)
  • Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R Follicular Activity Score of 0(Up to 128 weeks)
  • Serum Concentration of Litifilimab(Pre-dose up to 128 weeks)
  • 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)
  • 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)(Up to 128 weeks)
  • Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score From Baseline Value (Parent Study [NCT05531565]) to Week 104(Up to 104 weeks)
  • Percent Change in CLASI-D Score From Baseline Value (Parent Study [NCT05531565]) to Week 104(Up to 104 weeks)
  • Annualized Mild/Moderate and Severe Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rates Through Week 52(Up to 52 weeks)
  • Annualized Mild/Moderate and Severe SFI Rates Through Week 104(Up to 104 weeks)
  • Percentage of Participants With Oral Corticosteroid (OCS) Dose(Up to 104 weeks)
  • Percentage of Participants With OCS ≤ 7.5 Milligrams per day (mg/day)(Up to 104 weeks)
  • Percentage of Participants With OCS ≤ 5.0 mg/day(Up to 104 weeks)
  • 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)
  • 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)
  • 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)
  • 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)
  • Change From Baseline Value (Parent Study [NCT05531565]) in Patient Health Questionnaire-9 (PHQ-9) at Weeks 52 and 104(Baseline, Weeks 52 and 104)
  • Percentage of Participants who Achieve a Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI)-70 Response, Defined as a 70% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])(Up to 232 weeks)
  • Percentage of Participants who Achieve a CLASI-50 Response, Defined as a 50% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])(Up to 232 weeks)
  • Percentage of Participants who Achieve a CLASI-90 Response, Defined as a 90% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])(Up to 232 weeks)
  • 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 232 weeks)
  • Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0(Up to 232 weeks)
  • Percentage of Participants With a CLASI-70 Response Among CLASI-70 Responders at Long-Term Extension (LTE) Baseline(Day 1 (LTE Baseline) up to Up to 232 weeks)
  • Percentage of Participants With a CLASI-50 Response Among CLASI-50 Responders at LTE Baseline(Day 1 (LTE Baseline) up to 232 weeks)
  • Percentage of Participants With a CLASI-90 Response Among CLASI-90 Responders at LTE Baseline(Day 1 (LTE Baseline) up to 232 weeks)
  • 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 LTE Baseline(Day 1 (LTE Baseline) up to 232 weeks)
  • 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 1 (LTE Baseline) up to 232 weeks)
  • Percentage of Participants With a CLASI-70 Response Among CLASI-50 Responders at LTE Baseline(Day 1 (LTE Baseline) up to 232 weeks)
  • Percentage of Participants With Loss of Response, Defined as an Increase of ≥ 7 Points in CLASI-A Total Score From Baseline(Day 1 (LTE Baseline) up to 232 weeks)
  • Percentage of Participants who Achieve a CLASI A Score of 0 to 3(Up to 232 weeks)
  • Percentage of Participants who Achieve a CLASI-A Score of 0 to 5(Up to 232 weeks)
  • Percentage of Participants With a CLASI-A 0 to 3 Response Among CLASI-A 0 to 3 Responders at LTE Baseline(Day 1 (LTE Baseline) up to 232 weeks)
  • Absolute Change From Baseline in CLASI-A Score of Parent Study (NCT05531565) to Week 208(Day 1 (Baseline of Parent study) up to 208 weeks)
  • Percent Change From Baseline in CLASI-A Score of Parent Study (NCT05531565) to Week 208(Day 1 (Baseline of Parent study) up to 208 weeks)
  • Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score From Baseline Value (Parent Study [NCT05531565]) to Week 208(Up to 208 weeks)
  • Percent Change in CLASI-D Score From Baseline Value (Parent Study [NCT05531565]) to Week 208(Up to 208 weeks)
  • Annualized Mild/Moderate and Severe Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rates(Up to 208 weeks)
  • Percentage of Participants With Oral Corticosteroid (OCS) Dose Among Participants who Used OCS at Baseline in the Parent Study (NCT05531565)(Day 1 (Baseline of Parent study) up to 208 weeks)
  • Percentage of Participants With OCS ≤ 7.5 Milligrams per day (mg/day) Among Participants who Used OCS at Baseline in the Parent Study (NCT05531565)(Day 1 (Baseline of Parent study) up to 208 weeks)
  • Percentage of Participants With OCS ≤ 5.0 mg/day Among Participants who Used OCS at Baseline in the Parent Study (NCT05531565)(Day 1 (Baseline of Parent study) up to 208 weeks)
  • Change From Baseline Value (Parent Study [NCT05531565]) in Cutaneous Lupus Erythematosus - Quality of Life (CLE-QoL) at Week 208(Baseline, Week 208)
  • Change From Baseline Value (Parent Study [NCT05531565]) in European Quality of Life - 5-Dimensions Questionnaire, 3-Level Version (EQ-5D-3L) at Week 104(Baseline, Week 104)
  • Change From Baseline Value (Parent Study [NCT05531565]) in 36-Item Short Form Survey (SF-36) (acute version) at Week 104(Baseline, Week 104)
  • Change From Baseline Value (Parent Study [NCT05531565]) in Work Productivity and Activity Impairment (WPAI): Lupus at Week 104(Baseline, Week 104)
  • Change From Baseline Value (Parent Study [NCT05531565]) in Patient Health Questionnaire-9 (PHQ-9) at Week 104(Baseline, Week 104)
  • Change From Baseline Value (Parent Study [NCT05531565]) in Subject Global Assessment of Skin - Follow-up (SGA-Skin-FU) at Week 208(Baseline, Week 208)
  • Change From Baseline Value (Parent Study [NCT05531565]) in Numerical Rating Scale (NRS) for Pain in Skin Rash at Week 208(Baseline, Week 208)
  • Change From Baseline Value (Parent Study [NCT05531565]) in Numerical Rating Scale (NRS) for Itch in Skin Rash at Week 208(Baseline, Week 208)
  • Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in Standard Laboratory Parameters(Up to 208 weeks)
  • Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in Electrocardiogram (ECG) Results(Up to 232 weeks)
  • Number of Participants With Anti-BIIB059 Antibodies in Serum(Up to 232 weeks)
  • Serum Concentration of Litifilimab(Pre-dose up to 232 weeks)
  • Percentage of Participants With a CLASI-70 Response Among CLASI-70 Responders at Long-Term Extension (LTE) Baseline(Day 1 (LTE Baseline) up to 232 weeks)
  • Percentage of Participants With OCS ≤ 5.0 mg/day(Up to 104 weeks)
  • 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)
  • 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)
  • 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)
  • 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)
  • Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1(Up to 128 weeks)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R Follicular Activity Score of 0(Up to 128 weeks)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)(Up to 128 weeks)
  • Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score From Baseline Value (Parent Study [NCT05531565]) to Week 104(Up to 104 weeks)
  • Percent Change in CLASI-D Score From Baseline Value (Parent Study [NCT05531565]) to Week 104(Up to 104 weeks)
  • Annualized Mild/Moderate and Severe Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rates Through Week 52(Up to 52 weeks)
  • Annualized Mild/Moderate and Severe SFI Rates Through Week 104(Up to 104 weeks)
  • Percentage of Participants With Oral Corticosteroid (OCS) Dose(Up to 104 weeks)
  • Percentage of Participants With OCS ≤ 7.5 Milligrams per day (mg/day)(Up to 104 weeks)
  • 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)
  • 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)
  • 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)
  • 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)
  • Change From Baseline Value (Parent Study [NCT05531565]) in Patient Health Questionnaire-9 (PHQ-9) at Weeks 52 and 104(Baseline, 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(Baseline, 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(Baseline, 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(Baseline, Weeks 52 and 104)
  • Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in Standard Laboratory Parameters(Up to 128 weeks)
  • Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in Electrocardiogram (ECG) Results(Up to 104 weeks)
  • Number of Participants With Anti-BIIB059 Antibodies in Serum(Up to 128 weeks)
  • Serum Concentration of Litifilimab(Pre-dose up to 128 weeks)

研究者

发起方
Biogen
申办方类型
Industry
责任方
Sponsor

研究点 (108)

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