The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05531565
Recruitment Status : Recruiting
First Posted : September 8, 2022
Last Update Posted : June 17, 2024
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE August 19, 2022
First Posted Date  ICMJE September 8, 2022
Last Update Posted Date June 17, 2024
Actual Study Start Date  ICMJE September 13, 2022
Estimated Primary Completion Date October 20, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2022)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2022)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Part B (US+ROW): Absolute Change in CLASI-D Score [ Time Frame: Week 52 ]
  • Part B (US+ROW): Percent Change in CLASI-D Score [ Time Frame: Week 52 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Parts A and B (US+ROW): Percentage of Participants who Achieve a 70% Reduction in CLASI-A [ Time Frame: Up to Week 24 ]
  • Parts A and B (US+ROW): Percentage of Participants who Achieve a 50% Reduction in CLASI-A [ Time Frame: Up to Week 24 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Parts A and B (US+ROW): Number of Participants With Anti-BIIB059 Antibodies in Serum During the Study [ Time Frame: Up to Week 76 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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].
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Subacute Cutaneous Lupus Erythematosus
  • Chronic Cutaneous Lupus Erythematosus
Intervention  ICMJE
  • Drug: BIIB059 (litifilimab)
    Administered as specified in the treatment arm.
    Other Name: litifilimab
  • Drug: Placebo
    Administered as specified in the treatment arm.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: BIIB059 (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.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: BIIB059 (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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 2, 2022)
474
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 14, 2027
Estimated Primary Completion Date October 20, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com
Listed Location Countries  ICMJE Argentina,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Mexico,   Philippines,   Poland,   Portugal,   Puerto Rico,   Saudi Arabia,   Serbia,   Slovakia,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05531565
Other Study ID Numbers  ICMJE 230LE301
2020-000727-40 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Current Responsible Party Biogen
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Biogen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date June 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP