L931 Subacute cutaneous lupus erythematosus Subacute cutaneous lupus erythematosus
Conditions
Interventions
Pharmaceutical Form: Solution for injection Drug: BIIB059 225 mg (150mg/ml) Unit: milligrams Units per dose: 225mg Total N° of doses per patient: 15 Presentation: Pre-filled Syringe - Pharmaceutical F
Sponsors
Biogen Idec Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. Participant must be = 18 years of age at the time of signing the ICF. 3. All women of childbearing potential must practice highly effective contraception during the study treatment period and for 126 days after their last dose of study treatment. In addition, participants should not donate eggs during the study treatment period and for at least 126 days after their last dose of study treatment. Where applicable, postmenopausal status must be confirmed as follows: for women = 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea without an alternative medical cause and a serum FSH level = 40 mIU/mL; for women > 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea without an alternative medical cause and a serum FSH level = 40 mIU/mL, or at least 5 continuous years of natural (spontaneous) amenorrhea without an alternative medical cause (Section 11.5). 4. Must have a histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations. For participants without historical biopsy data, a skin biopsy must be performed from an active CLE lesion during the Screening period to confirm CLE diagnosis prior to randomization. Biopsies can be processed at a local or central laboratory, at the Investigator’s discretion. Diagnosis will be adjudicated together with CLASI and CLA IGA R prior to randomization. 5. Must have active cutaneous manifestations that meet the following criteria (per adjudication at screening and confirmation by the Investigator at randomization): a. at least 1 active SCLE lesion with a minimum CLASI A erythema score = 2 and CLASI-A scale/hypertrophy score =1; AND/OR b. at least 1 active CCLE lesion with a minimum CLASI A erythema score = 2 and CLASI D score of scarring = 1 6. Must have a CLASI-A score = 10 adjudicated at Screening and confirmed by the Investigator at randomization. 7. Must have a CLA-IGA-R Erythema score = 3 adjudicated at Screening and confirmed by the Investigator at randomization. 8. Must have a CLA-IGA-R OMC score = 1 adjudicated at Screening and confirmed by the Investigator at randomization. 9. Must have an active CLE lesion despite an adequate trial of antimalarial treatment. One of the 2 conditions should be met: a) antimalarial agents used for at least 12 weeks (either continuous or cumulative) prior to Screening OR b) previously documented lack of therapeutic effect for at least 12 weeks of treatment (not continuous is acceptable) and/or previously documented discontinuation of antimalarial agents due to poor tolerability and/or side effects.
Exclusion criteria
Exclusion criteria: 1. Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered. A washout period will be required prior to randomization (see Section 7.7.1.2). Participation in observational registries will be allowed. 2. Medical History and Current Health Status History or positive test result at Screening for HIV. 3. Current hepatitis C infection (defined as positive HCV antibody and detectable HCV RNA). Participants with positive HCV antibody and undetectable HCV RNA are eligible to participate in the study (United States Centers for Disease Control and Prevention). NOTE: Eligible participants with risk for HCV exposure can be tested every 6 months during the study at the discretion of the Investigator. 4. Current hepatitis B virus infection (defined as positive for HBsAg and/or total anti-HBc). Participants with the following immune profiles according to United States Centers for Disease Control and Prevention are eligible to participate in the study: • Immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive anti-HBc, and positive anti-HBs); or • Previous vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti-HBs). NOTE: In accordance with the “Guideline for Prevention of Immunosuppressive Therapy or Chemotherapy Against Hepatitis B” (Japanese Society of Hepatology, Hepatitis B Treatment Guideline, Version 3.4, Drafting Committee for Hepatitis Management Guidelines, Document 3). Japan will follow exclusion criterion: o Current hepatitis B infection (defined as positive for HBsAg and/or total anti HBc) or previous hepatitis B infection (defined as negative HBsAg with positive anti-HBc and/or positive anti-HBs). o Participants with previous hepatitis B vaccination showing only anti-HBs positive are eligible to participant in the study. 5. History of chronic, recurrent (3 or more of the same type of infection in a 52-week period) or recent serious infection (e.g., pneumonia, septicemia) including viral infections, as determined by the Investigator, or requiring anti-infective treatment within the 12 weeks prior to and during Screening. Para ver la lista completa por favor referirise a las paginas 99 a 104 del protocolo en ingles
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A (phase 2) • Proportion of participants who achieve a CLA IGA R Erythema score of 0 or 1, defined as clear or almost clear skin disease activity at Week 16. NAME OF THE RESULT: Part A (phase 2) • Proportion of participants who achieve a CLA IGA R Erythema score of 0 or 1, defined as clear or almost clear skin disease activity at Week 16. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 16;Part B (phase 3) Proportion of participants who achieve CLASI 70 response, defined as = 70% decrease in CLASI-A score from Baseline to Week 24. NAME OF THE RESULT: Part B (phase 3) Proportion of participants who achieve CLASI 70 response, defined as = 70% decrease in CLASI-A score from Baseline to Week 24. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A (phase 2) • Proportion of participants who achieve a CLA IGA R Erythema score of 0 or 1, defined as clear or almost clear skin disease activity at Week 16. NAME OF THE RESULT: Part A (phase 2) • Proportion of participants who achieve a CLA IGA R Erythema score of 0 or 1, defined as clear or almost clear skin disease activity at Week 16. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 16;Part B (phase 3) Proportion of participants who achieve CLASI 70 response, defined as = 70% decrease in CLASI-A score from Baseline to Week 24. NAME OF THE RESULT: Part B (phase 3) Proportion of participants who achieve CLASI 70 response, defined as = 70% decrease in CLASI-A score from Baseline to Week 24. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 24;Part A (phase 2) • Proportion of participants who achieve a CLA IGA R Erythema score of 0 or 1, defined as clear or almost clear skin disease activity at Week 24. • Proportion of participants who achieve a CLA IGA R OMC score of 0 or 1 (defined as clear or almost clear skin disease activity) and at least 1 level of improvement from Baseline, at Week 16 and Week 24, respectively. • Proportion of participants who achieve a CLA IGA-R OMC score of 0, defined as clear skin disease activity at Week 16 and Week 24, respectively. NAME OF THE RESULT: Part A (phase 2) • Proportion of participants who achieve a CLA IGA R Erythema score of 0 or 1, defined as clear or almost clear skin disease activity at Week 24. • Proportion of participants who achieve a CLA IGA R OMC score of 0 or 1 (defined as clear or almost clear skin disease activity) and at least 1 level of improvement from Baseline, at Week 16 and Week 24, respectively. • Proportion of participants who achieve a CLA IGA-R OMC score of 0, defined as clear skin disease activity at Week 16 and Week 24, respectively. Para ver la lista completa por favor referir | — |
Countries
Arabia Saudi, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, France, Germany, Hungary, Italy, Japan, Korea South, Mexico, Peru, Philippines, Poland, Puerto Rico, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kindgdom, United States
Contacts
Public ContactMiriam Luz Vargas
IQVIA RDS PERU S.R.L.
Outcome results
None listed