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

Phase 1

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

• Registration Number: EUCTR2015-000372-95-HU
• Lead Sponsor: Ablynx N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-30
• Last Update Posted: 26 February 2018

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