Clinical Trial: A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase II Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects With Moderate to
Brief Summary:
Primary 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 objectives:
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.
Detailed Summary:
Sponsor: Ablynx
Current Primary Outcome: The percentage of subjects who achieved a response at Week 24 according to the composite m BICLA (BILAG-based Combined Lupus Assessment) score [ Time Frame: Week 24 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in SLE disease activity [ Time Frame: From screening to Week 48 ]As measured by change in: composite (m)BICLA, mSRI (modified Systemic lupus erythematosus responder index), standard SRI, (m)SRI with more stringent (m)SLEDAI-cut-offs: SRI-5, SRI-6, SRI-7, SRI-8, mSLEDAI-2K, standard SLEDAI-2K, BILAG-2004, physician's global assessment
- The change from baseline in patient's global assessment over time. [ Time Frame: Week 48 ]
- The change from baseline in renal parameters [ Time Frame: Week 48 ]
- The percentage of patients experiencing a treatment failure [ Time Frame: Week 24 and Week 48. ]
- The number of patients with a reduction in flare rate [ Time Frame: Week 24 and Week 48 ]as measured by BILAG-2004 scoring and by the Severe SELENA SLEDAI Flare Index
- The change from baseline in corticosteroids use [ Time Frame: Week 24 - Week 48 ]
- The change from baseline in the physical and mental component scores of SF-36 [ Time Frame: Week 24 and Week 48 ]
- Change from baseline in joints count over time [ Time Frame: Week 48 ]
- The change from baseline of Cutaneous lupus erythematosus disease area and severity index (CLASI) [ Time Frame: Week 12, Week 24 and Week 48 ]
- The determination of ALX-0061 in blood samples (composite) [ Time Frame: Week 12, Week 24 and Week 48 ]
- The determination of biomarkers in blood samples [ Time Frame: Week 60 ]
- The determination of anti-ALX-0061 antibodies in blood samples (composite) [ Time Frame: Week 60 ]
- The incidence of adverse events and serious adverse events. [ Time Frame: Week 60 ]
- The change from baseline in clinical laboratory parameters (composite) [ Time Frame: Week 60 ]
Original Secondary Outcome:
- Change in SLE disease activity [ Time Frame: From screening to Week 48 ]As measured by change in: composite (m)BICLA, mSRI (modified Systemic lupus erythematosus responder index), standard SRI, (m)SRI with more stringent (m)SLEDAI-cut-offs: SRI-5, SRI-6, SRI-7, SRI-8, mSLEDAI-2K, standard SLEDAI-2K, BILAG-2004, physician's global assessment
- The change from baseline in patient's global assessment over time. [ Time Frame: Week 48 ]
- The change from baseline in renal parameters [ Time Frame: Week 48 ]
- The percentage of patients experiencing a treatment failure [ Time Frame: Week 24 and Week 48. ]
- Frequency of flares [ Time Frame: Week 24 and Week 48 ]as measured by BILAG-2004 scoring and by the Severe SELENA SLEDAI Flare Index
- The change from baseline in corticosteroids use [ Time Frame: Week 24 - Week 48 ]
- The change from baseline in the physical and mental component scores of SF-36 [ Time Frame: Week 24 and Week 48 ]
- Change from baseline in joints count over time [ Time Frame: Week 48 ]
- The change from baseline of Cutaneous lupus erythematosus disease area and severity index (CLASI) [ Time Frame: Week 12, Week 24 and Week 48 ]
- The determination of ALX-0061 in blood samples (composite) [ Time Frame: Week 12, Week 24 and Week 48 ]
- The determination of biomarkers in blood samples [ Time Frame: Week 60 ]
- The determination of anti-ALX-0061 antibodies in blood samples (composite) [ Time Frame: Week 60 ]
- The incidence of adverse events and serious adverse events. [ Time Frame: Week 60 ]
- The change from baseline in clinical laboratory parameters (composite) [ Time Frame: Week 60 ]
Information By: Ablynx
Dates:
Date Received: April 29, 2015
Date Started: July 2015
Date Completion: March 2018
Last Updated: May 19, 2017
Last Verified: May 2017