Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus

Phase 1

Conditions: MedDRA version: 19.0Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Moderate to Severe Active Systemic Lupus Erythematosus

Registration Number: EUCTR2015-000372-95-DE

Lead Sponsor: Ablynx N.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. Male or female adults = 18 years and < 65 years of age.
2. Have a diagnosis of SLE for at least 6 months prior to screening and fulfill the 1997 ACR or 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.
3. Have moderate to severe active SLE.
5. Have seropositive disease at screening.
6. Subject must be at least on one or more of the treatments for SLE as defined in the protocol.

Others as defined in the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Have an A score on the revised BILAG-2004 other than in the mucocutaneous and/or musculoskeletal system at screening and at baseline for the organ systems that can be clinically assessed.
2. Have a systemic inflammatory disease other than SLE.
3. Clinically significant infection treated or needing treatment.
4. Any active or recurrent viral infection that based on the Investigator´s clinical assessment makes the subject unsuitable for the study.
5. Have a history of, or current, class III or IV congestive heart failure.
6. Have received prior therapy blocking the IL-6 pathway.

Others as defined in the protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy and safety of different dose regimens of ALX-0061 administered subcutaneously (s.c.) to subjects with moderate to severe active, seropositive SLE compared to placebo.;Secondary Objective: To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate, steroid reduction and health-related quality of life, with different dose regimens of ALX-0061.;Primary end point(s): The percentage of subjects who achieved a response at Week 24 according to the composite mBICLA (BILAG-based Combined Lupus Assessment) score. ;Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome Measures