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A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)

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ClinicalTrials.gov Identifier: NCT05531565
Recruitment Status : Recruiting
First Posted : September 8, 2022
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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Brief Summary:
The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].

Condition or disease Intervention/treatment Phase
Subacute Cutaneous Lupus Erythematosus Chronic Cutaneous Lupus Erythematosus Drug: BIIB059 (litifilimab) Drug: Placebo Phase 2 Phase 3

Detailed Description:
BIIB059 is a humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting blood dendritic cell antigen 2 and is being investigated for the potential treatment of systemic lupus erythematosus and cutaneous lupus erythematosus.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 474 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in 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)
Actual Study Start Date : September 13, 2022
Estimated Primary Completion Date : July 13, 2026
Estimated Study Completion Date : December 13, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A (Phase 2): BIIB059
Participants will receive BIIB059 subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 20, with an additional dose of BIIB059 at Week 2 during the double-blind placebo-controlled (DBPC) treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the extended treatment period (ETP) from Week 24 to Week 48, with an additional dose of BIIB059-matching placebo at Week 26.
 Drug: BIIB059 (litifilimab)
Administered as specified in the treatment arm.
Other Name: litifilimab
Placebo Comparator: Part A (Phase 2): Placebo
Participants will receive BIIB059-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of BIIB59-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059 at Week 26.
 Drug: Placebo
Administered as specified in the treatment arm.
Experimental: Part B (Phase 3): BIIB059
Participants will receive BIIB059 SC Q4W from Week 0 to Week 20, with an additional dose of BIIB059 at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059-matching placebo at Week 26.
 Drug: BIIB059 (litifilimab)
Administered as specified in the treatment arm.
Other Name: litifilimab
Placebo Comparator: Part B (Phase 3): Placebo
Participants will receive BIIB059-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of BIIB59-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059 at Week 26.
 Drug: Placebo
Administered as specified in the treatment arm.


Outcome Measures
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Primary Outcome Measures :
  1. Parts A (US+ROW) and B (US): 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: Week 16 ]
  2. Part B (ROW): Percentage of Participants who Achieve Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-70) Response, Defined as ≥ 70% Decrease in CLASI-A Score From Baseline [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Part A (US+ROW): Percentage of Participants who Achieve a CLASI-50 Response, Defined as a ≥ 50% Decrease in CLASI-A Score From Baseline [ Time Frame: Weeks 16 and 24 ]
  2. Part A (US+ROW): Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score [ Time Frame: Baseline to Week 52 ]
  3. Part B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in Full Analysis Set (FAS), who had CLA-IGA-R Erythema Score ≥3 and OMC Score ≥3 at Baseline [ Time Frame: Weeks 16 and 24 ]
  4. Part B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in FAS, who had CLA-IGA-R Erythema Score ≥3 and OMC Score ≥3 at Baseline [ Time Frame: Weeks 16 and 24 ]
  5. Part B (US+ROW): Percentage of Participants who Achieve at Least 1 Level of Improvement From Baseline in the CLA-IGA-R Erythema Score [ Time Frame: Up to Week 24 ]
  6. Part B (US+ROW): Absolute Change in CLASI-D Score [ Time Frame: Week 52 ]
  7. Part B (US+ROW): Percent Change in CLASI-D Score [ Time Frame: Week 52 ]
  8. Part B (US+ROW): Change From Baseline in Cutaneous Lupus Erythematosus-Quality of Life (CLE-QoL) Score [ Time Frame: Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52 ]
  9. Part B (US+ROW): Change From Baseline in Dermatology Life Quality Index (DLQI) Score [ Time Frame: Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52 ]
  10. Parts A (US+ROW) and B (US): Percentage of Participants who Achieve a CLASI-70 Response, Defined as a ≥ 70% Decrease in CLASI-A Score From Baseline [ Time Frame: Part A (US+ROW): Weeks 16 and 24; Part B (US): Week 16 ]
  11. Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1 [ Time Frame: Part A (US+ROW): Week 24; Part B (ROW): Week 24; Part B (US+ROW): Up to Week 24 ]
  12. Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1 and at Least 1 Level of Improvement From Baseline [ Time Frame: Part A (US+ROW): Weeks 16 and 24; Part B (US): Week 16; Part B (ROW): Week 24; Part B (US+ROW): Up to Week 24 ]
  13. Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0 [ Time Frame: Part A (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24 ]
  14. Parts A and B (US+ROW): Percentage of Participants With at Least 1 Level of Improvement From Baseline in CLA-IGA-R OMC Score [ Time Frame: Part A (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24 ]
  15. Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Follicular Activity Score of 0 [ Time Frame: Parts A and B (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24 ]
  16. Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 or 1 [ Time Frame: Up to Week 24 ]
  17. Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 to 3 [ Time Frame: Up to Week 24 ]
  18. Parts A and B (US+ROW): Percentage of Participants who Achieve a 70% Reduction in CLASI-A [ Time Frame: Up to Week 24 ]
  19. Parts A and B (US+ROW): Percentage of Participants who Achieve a 50% Reduction in CLASI-A [ Time Frame: Up to Week 24 ]
  20. Parts A and B (US+ROW): Percentage of Participants who Achieve a 7-Point Reduction From Baseline in CLASI-A Score [ Time Frame: Up to Week 24 ]
  21. Parts A and B (US+ROW): Percentage of Participants With a CLASI-70 Response at Week 52 Among CLASI-70 Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive BIIB059 During the DBPC Treatment Period (TP) [ Time Frame: Week 52 ]
  22. Parts A and B (US+ROW): Percentage of Participants With CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive BIIB059 During the DBPC TP [ Time Frame: Week 52 ]
  23. Parts A and B(US+ROW):Percentage of Participants With CLA-IGA-R OMC Score of 0/1 and at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Responders at Weeks 16 and 24, Respectively, who Were Assigned to Receive BIIB059 in DBPC TP [ Time Frame: Week 52 ]
  24. Parts A and B (US+ROW): Percentage of Participants With CLA-IGA-R OMC Score of 0 at Week 52 Among Responders With CLA-IGA-R OMC Score of 0 at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive BIIB059 During the DBPC TP [ Time Frame: Week 52 ]
  25. Parts A and B(US+ROW):Percentage of Participants With CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive BIIB059 in DBPC TP [ Time Frame: Week 52 ]
  26. Parts A and B (US+ROW): Percentage of Participants With a CLASI-70 Response at Week 52 Among CLASI-70 Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP [ Time Frame: Week 52 ]
  27. Parts A and B (US+ROW): Percentage of Participants With a CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP [ Time Frame: Week 52 ]
  28. Parts A, B(US+ROW):Percentage of Participants With CLA-IGA-R OMC Score of 0/1 and at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Nonresponders at Weeks 16 and 24, Respectively, who Were Assigned to Receive Placebo in DBPC TP [ Time Frame: Week 52 ]
  29. Parts A and B (US+ROW): Percentage of Participants With a CLA-IGA-R OMC Score of 0 at Week 52 Among CLA-IGA-R OMC Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP [ Time Frame: Week 52 ]
  30. Parts A and B(US+ROW): Percentage of Participants who Achieve CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Nonresponders at Weeks 16 and 24, Respectively, who Were Randomly Assigned to Receive Placebo in DBPC TP [ Time Frame: Week 52 ]
  31. Parts A and B (US+ROW): Annualized Mild and Moderate Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rate and Annualized Severe SFI Rate Through Week 24 [ Time Frame: Up to Week 24 ]
  32. Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 16 [ Time Frame: Up to Week 16 ]
  33. Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 52 [ Time Frame: Up to Week 52 ]
  34. Parts A and B (US+ROW): Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 76 ]
  35. Parts A and B (US+ROW): Number of Participants With Anti-BIIB059 Antibodies in Serum During the Study [ Time Frame: Up to Week 76 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations.
  2. Must have active cutaneous manifestations that meet study criteria.
  3. Must have a CLASI-A score ≥10.
  4. Must have an active CLE lesion despite an adequate trial of antimalarial treatment.

Key Exclusion Criteria:

  1. Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
  2. Active severe lupus nephritis.
  3. Active neuropsychiatric SLE.
  4. Use of intralesional corticosteroids within 1 week prior to Screening and during the study.
  5. Use of immunosuppressive or disease-modifying treatments for SLE or CLE [via an oral, intravenous (IV), or SC route] that were initiated less than 12 weeks prior to randomization, have not been at a stable and allowable dose.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05531565


Contacts
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Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

Locations
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Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT05531565    
Other Study ID Numbers: 230LE301
2020-000727-40 ( EudraCT Number )
First Posted: September 8, 2022    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
URL: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biogen:
Cutaneous Lupus Erythematosus (CLE)
Acute Cutaneous Lupus Erythematosus (ACLE)
Discoid Lupus Erythematosus (DLE)
Systemic Lupus Erythematosus (SLE)
Lupus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Discoid
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Skin Diseases