A long-term extension study to assess the sustained safety and efficacy of Litifilimab in adults with active subacute and/or chronic cutaneous lupus erythematosus (CLE)
Summary description of the study
Litifilimab is an investigational drug being studied for the treatment of patients with CLE. Previous studies have examined the safety of Litifilimab and whether it can reduce the severity of CLE. One of these studies, 230LE301, is still ongoing and includes a treatment period of about 1 year. It first compares the Litifilimab treatment with placebo, and then all participants receive Litifilimab to complete the study. This study, 230LE305, is a long-term extension of the main study 230LE301, in which participants will be treated for up to 2 additional years for CLE. Researchers want to learn more about the long-term safety of Litifilimab and how well it can treat CLE.
(BASEC)
Intervention under investigation
All participants who have completed treatment in the main study 230LE301 may be enrolled in this study. Approximately 322 participants are expected to be enrolled worldwide. The last visit date of the main study is the first visit date of this study. The treatment duration is up to 2 years (with up to 27 study visits) following a 6-month safety follow-up period (with up to 6 study visits). Each participant will receive Litifilimab once every 4 weeks during the treatment period. Litifilimab is administered as an injection under the skin. In addition to physical examinations, tests and measures such as blood and urine tests will be conducted, electrocardiograms (ECGs) will be recorded, and questionnaires to measure disease symptoms and quality of life will be completed.
(BASEC)
Disease under investigation
Researchers are looking for new options to treat patients with cutaneous lupus erythematosus (CLE). CLE is a specific form of lupus that primarily affects the skin. It causes rashes and painful lesions that itch and are tender. These rashes typically occur on areas of skin exposed to sunlight, such as the face, neck, and arms. CLE can cause scarring, hair loss, and persistent changes in skin color. Currently, there are no medications specifically approved for the treatment of CLE. Topical ointments may be applied to heal the rashes and lesions. Steroids and antimalarial drugs may help control the immune system and reduce inflammation.
(BASEC)
Completion of study treatment up to the visit date in week 48 of the main study and attendance at the visit date in week 52 at the end of the main study (BASEC)
Exclusion criteria
- Discontinuation of the investigational drug prior to week 48 of the main study 230LE301 - Withdrawal from the study prior to week 52 of the main study 230LE301 (e.g., withdrawal of consent) - Diseases, conditions, or abnormalities that in the opinion of the investigator make the participant unsuitable for the long-term extension study - Development of moderate to severe worsening of organ-specific manifestations of lupus, including cutaneous lupus manifestations, that would require a change in immunosuppressive therapy - Use of prohibited concomitant medications, therapies, or measures during the main study - Immunization with live vaccines or live attenuated vaccines within 4 weeks prior to the visit date for baseline assessments, during the entire study, and for 24 weeks after the last dose of the investigational drug (BASEC)
Trial sites
Lausanne, St. Gallen
(BASEC)
Sponsor
Biogen Idec Research Ltd, UK Biogen Switzerland AG
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Antonio Cozzio
+41 71 494 2030
studien.dermatologie@clutterkssg.chHoch Health Ostschweiz, Kantonsspital St. Gallen
(BASEC)
General Information
Biogen
(ICTRP)
Scientific Information
Biogen
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
15.02.2024
(BASEC)
ICTRP Trial ID
NCT06044337 (ICTRP)
Official title (approved by ethics committee)
A Multicenter, Open-label, Single-arm, Phase 3 Long-Term Extension Study to Eval-uate 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) (BASEC)
Academic 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 (ICTRP)
Public title
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) (ICTRP)
Disease under investigation
Subacute Cutaneous Lupus ErythematosusChronic Cutaneous Lupus Erythematosus (ICTRP)
Intervention under investigation
Drug: BIIB059 (litifilimab) (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion 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. (ICTRP)
not available
Primary and secondary end points
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (ICTRP)
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 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 = 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;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 (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Medical Director, Biogen (ICTRP)
Secondary trial IDs
2023-504863-17-00, 230LE305 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06044337 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available