A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (LTE AMETHYST)
- Conditions
- Chronic Cutaneous Lupus ErythematosusSubacute Cutaneous Lupus Erythematosus
- Interventions
- Drug: BIIB059 (litifilimab)
- Registration Number
- NCT06044337
- Lead Sponsor
- Biogen
- Brief Summary
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) 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 learning 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 unwanted medical 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 assess the effect litifilimab and CLE has on the quality of life of participants using a group of questionnaires. They will also study 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.
* The treatment period will last up to 104 weeks, or 2 years.
* There will be a follow-up safety period that lasts up to 24 weeks.
* In total, participants will have up to 33 study visits.
* The total study duration for participants will be up to 128 weeks.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 322
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BIIB059 BIIB059 (litifilimab) Participants will receive BIIB059 subcutaneously, once every 4 weeks up to Week 100.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Up to 128 weeks
- Secondary Outcome Measures
Name Time Method 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 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 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
Trial Locations
- Locations (51)
Revival Research Institute, LLC
🇺🇸Troy, Michigan, United States
Università degli studi di Firenze
🇮🇹Firenze, Italy
David Fivenson, MD, Dermatology, PLLC
🇺🇸Ann Arbor, Michigan, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Inland Rheumatology Clinical Trials, Inc.
🇺🇸Upland, California, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Thurston Arthritis Research Center
🇺🇸Chapel Hill, North Carolina, United States
Duke Dermatology South Durham
🇺🇸Durham, North Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Precision Comprehensive Clinical Research Solutions
🇺🇸Grapevine, Texas, United States
Centro de Investigaciones Medicas Tucuman
🇦🇷San Miguel de Tucuman, Tucuman, Argentina
APRILLUS Asistencia e Investigacion
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
🇧🇷São Paulo, Sao Paulo, Brazil
DCC 'Alexandrovska', EOOD
🇧🇬Sofia, Bulgaria
DCC Focus 5 - MEOH OOD
🇧🇬Sofia, Bulgaria
Laser Rejuvenation Clinics, Inc.
🇨🇦Calgary, Alberta, Canada
DIEX Recherche Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
Centro Medico SkinMed
🇨🇱Las Condes, Chile
CIEC - Centro Internacional de Estudios Clínicos
🇨🇱Santiago, Chile
Clinical Research Chile SpA
🇨🇱Valdivia, Chile
Hopital Larrey
🇫🇷Toulouse Cedex 9, Haute Garonne, France
Hopital Edouard Herriot - CHU Lyon
🇫🇷Lyon, Rhone, France
Hopital Tenon
🇫🇷Paris, France
Universitaetsklinikum Erlangen
🇩🇪Erlangen, Bayern, Germany
Fachklinik Bad Bentheim Dermatologie
🇩🇪Bad Bentheim, Niedersachsen, Germany
Klinikum Oldenburg AoeR
🇩🇪Oldenburg, Niedersachsen, Germany
Universitaetsklinikum Muenster
🇩🇪Muenster, Nordrhein Westfalen, Germany
Universitaetsklinikum Halle (Saale)
🇩🇪Halle, Sachsen Anhalt, Germany
Universitaetsklinikum Carl Gustav Carus TU
🇩🇪Dresden, Sachsen, Germany
Pecsi Tudomanyegyetem Klinikai Kozpont
🇭🇺Pecs, Hungary
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
Kanazawa University Hospital
🇯🇵Kanazawa-shi, Ishikawa-Ken, Japan
Teikyo University Hospital
🇯🇵Itabashi-ku, Tokyo-To, Japan
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Clinstile, S.A. de C.V.
🇲🇽Ciudad de Mexico, Distrito Federal, Mexico
Investigacion y Biomedicina de Chihuahua, S.C.
🇲🇽Chihuahua, Mexico
Centro de investigacion medica y reumatologia
🇲🇽Guadalajara, Mexico
University Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Artromac n.o.
🇸🇰Kosice, Slovakia
Hospital Universitario Rio Hortega
🇪🇸Valladolid, Cantabria, Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Córdoba, Spain
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Karolinska Universitetssjukhuset - Solna
🇸🇪Solna, Sweden
Centre Hospitalier Universitaire Vaudois (CHUV)
🇨🇭Lausanne, Lucerne (Luzern), Switzerland
Kantonsspital St. Gallen
🇨🇭St. Gallen, Switzerland
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Queen Elizabeth Hospital
🇬🇧Birmingham, West Midlands, United Kingdom