E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic Lupus Erythematosus (SLE) with Active Skin Manifestations and Active Cutaneous Lupus Erythematosus (CLE) with or without Systemic Manifestations |
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E.1.1.1 | Medical condition in easily understood language |
Systemic Lupus Erythematosus (SLE) with Active Skin Manifestations and Active Cutaneous Lupus Erythematosus (CLE) with or without Systemic Manifestations |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042945 |
E.1.2 | Term | Systemic lupus erythematosus |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary purpose of the study is to evaluate the efficacy of BIIB059 in
reducing disease activity in participants with systemic lupus erythematosus (SLE) with active cutaneous manifestations and joint involvement (Part A), and in participants with active CLE (subacute CLE (SCLE) or chronic CLE (CCLE), including discoid lupus erythematosus (DLE) with or without systemic manifestations (Part B). |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate additional efficacy parameters of BIIB059 in reducing SLE/CLE disease activity, pharmacokinetic parameters, safety and tolerability of BIIB059. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Key Inclusion Criteria:
1.Diagnosis of systemic lupus erythematosus (SLE) fulfilling at least 4 out of 11 of the 1997 revised American College of Rheumatology (ACR) classification criteria for SLE along with active skin manifestations and joint involvement.
2.At least 4 tender joints and at least 4 swollen joints with at least 4 ofthe swollen joints in the proximal interphalangeal (PIP) joints, metacarpophalangeal (MCP) joints and/or wrist.
3.Demonstrate at least one sign of active lupus skin disease, includingacute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), and/or chronic cutaneous lupus erythematosus (CCLE) (e.g., discoid lupus erythematosus (DLE)), with skin activity
defined by SLE Disease Activity Index 2000 (SLEDAI-2K) at the time of Screening and randomization.
NOTE: Other protocol defined Inclusion criteria may apply
Key inclusion criteria for Part B:
1. Active skin manifestations Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) ≥8)) and a diagnosis of cutaneous lupus erythematosus (CLE) that has been histologically confirmed (in the past or at Screening), with or without SLE manifestations.
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E.4 | Principal exclusion criteria |
Key Exclusion Criteria:
1.Active lupus nephritis or moderate-to-severe or chronic kidneydisease.
2.Any active skin conditions other than CLE that may interfere with thestudy (e.g., psoriasis, non-LE skin lupus, drug-induced lupus).
3.History of chronic, recurrent, or recent serious infection.
4.History of chronic, recurrent (3 or more of the same type of infectionin a 12-month period), or recent serious infection (e.g., pneumonia, septicemia, herpes zoster) as determined by the Investigator and requiring anti-infective treatment within 12 weeks prior to Screening.
5.Use of immunosuppressive or disease-modifying treatments for SLEor CLE that were initiated less than 12 weeks prior to Randomization.
NOTE: Other protocol defined Exclusion criteria may apply
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E.5 End points |
E.5.1 | Primary end point(s) |
Part A: Change from Baseline in Active Joint Count (28-joint Assessment) to Week 24.
Part B: The percent change in Cutaneous Lupus Erythematosus Disease Area and Severity Index--Activity (CLASI-A) score from Baseline to Week 16.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Percentage of Participants with
CLASI-50 Response at Weeks 12, 16, and 24
Percent Change from Baseline in CLASI-A Score to Weeks 12, 16, and 24 (Part A) and Week 12 (Part B)
Percentage of Participants with a ≥ 4-point reduction in CLASIA score Relative to Baseline at
Weeks 12 and 16 (Party B) and
Week 24 (Part A)
Percentage of Participants with a Composite Response
Change from Baseline in
Systemic Lupus
Erythematosus Disease
Activity Index 2000 (SLEDAI2K) Score to Week 24
Percentage of Participants with no New Organ System
Affected
Number of participants experiencing Adverse Events
(AEs) and Serious Adverse
Events (SAEs)
BIIB059 clearance
BIIB059 volume of distribution
BIIB059 absorption rate
Number of participants with clinically significant laboratory assessment abnormalities
Number of participants with
clinically significant Vital sign abnormalities
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Number of participants with positive serum BIIB059 antibodies
Absolute change from baseline over time in immunoglobulin levels
Absolute change from baseline over time in vaccine titers
Percent change from baseline over time in immunoglobulin levels
Percent change from baseline over time in vaccine titers
Change from baseline in
Physician's Global Assessment
(PGA) visual analog scale
(VAS) score
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Bulgaria |
Colombia |
Israel |
Korea, Republic of |
Mexico |
Philippines |
Poland |
Serbia |
Taiwan |
Thailand |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study is the last subject, last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 10 |