A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02437890
• Date of registration: 29/04/2015
• Prospective Registration: Yes
• Primary sponsor: Ablynx
• Public title: A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus
• Scientific 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 Severe Active Systemic Lupus Erythematosus
• Date of first enrolment: July 2015
• Target sample size: 312
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02437890
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Argentina, Chile, Czech Republic, Czechia, Germany, Hungary, Korea, Republic of, Mexico, Peru, Philippines, Poland, Portugal, Russian Federation, Serbia, Spain, Taiwan, Ukraine, United States

Contacts

• Name: Medical Lead
• Affiliation: Ablynx NV

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Man or woman = 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
American College of Rheumatology (ACR) or 2012 Systemic Lupus International
Collaborating Clinics (SLICC) classification criteria

3. Have moderate to severe active SLE

4. Have seropositive disease at screening

5. Subject must be at least on one or more of the treatments for SLE as listed in the
protocol

6. Others as defined in the protocol

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 received prior therapy blocking the interleukin-6 (IL-6) pathway

6. Others as defined in the protocol



Age minimum: 18 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Intervention(s)

Biological: Placebo

Biological: ALX-0061

Primary Outcome(s)

Number and Percentage of Subjects Who Achieved a Response at Week 24 According to the Modified British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (mBICLA) Score [Time Frame: At Week 24 visit]

Secondary Outcome(s)

Actual Values of Complement C4 Concentrations at Baseline, Week 24, and Week 48 [Time Frame: At Baseline, Week 24, and Week 48]

Actual Values of Complement C3 Concentrations at Baseline, Week 24, and Week 48 [Time Frame: At Baseline, Week 24, and Week 48]

Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12, Week 24 and Week 48 [Time Frame: At Week 12, Week 24 and Week 48]

Number and Percentage of Subjects With BILAG-2004 Normal Improvement in Mucocutaneous System at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Change From Baseline in 28 Joint Count Tenderness (TJC28) Score at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Number of and Percentage Treatment Failures From Baseline to Week 24 and Week 48 [Time Frame: From Baseline to Week 24 and Week 48]

Number and Percentage of Subjects Whose Daily Dose of Steroids Was Reduced Without Severe Flares During Weeks 40-48 [Time Frame: Between Week 40 and Week 48]

Actual Values for Hemolytic Complement Component 50 (CH50) at Baseline, Week 24, and Week 48 [Time Frame: At Baseline, Week 24, and Week 48]

Actual Values of C-reactive Protein (CRP) Concentrations at Baseline, Week 24, and Week 48 [Time Frame: At Baseline, Week 24, and Week 48]

Actual Values of Soluble Interleukin 6 Receptor (sIL-6R) Concentrations at Baseline, Week 24, and Week 48 [Time Frame: At Baseline, Week 24, and Week 48]

Change From Baseline in 28 Joint Count Swollenness (SJC28) Score at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Actual Values of Anti-double-stranded (ds) DNA Concentrations at Baseline, Week 24, and Week 48 [Time Frame: at Baseline, Week 24, and Week 48]

Actual Values of Fibrinogen Concentrations at Baseline, Week 24, and Week 48 [Time Frame: At Baseline, Week 24, and Week 48]

BILAG-2004 Total Score at Baseline, Week 24 and Week 48 [Time Frame: At Baseline, Week 24 and Week 48]

Change From Baseline in Physician's Global Assessment (PGA) at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

ALX-0061 Serum Concentrations at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Number and Percentage of Subjects With BILAG-2004 Normal Improvement in Musculoskeletal System at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Change From Baseline in Mental Component Scores of SF-36 at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Change From Baseline in Modified Systemic Lupus Erythematosus Disease Activity Index 2000 (mSLEDAI-2K) Score at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Change From Baseline in Proteinuria at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Change From Baseline in Serum Creatinine at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Number and Percentage of Subjects Who Were Treatment-emergent (TE) Anti-drug Antibody (ADA) Positive [Time Frame: From first administration of ALX-0061 up to and including follow-up]

Change From Baseline in CLASI Damage Score at Week 12, Week 24 and Week 48 [Time Frame: At Week 12, Week 24 and Week 48]

Number and Percentage of Subjects With BILAG-2004 Normal Improvement at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Number and Percentage of Subjects With mSRI-7 Response at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Number and Percentage of Subjects With mSRI-8 Response at Week 24 and Week 48. [Time Frame: At Week 24 and Week 48]

Change From Baseline in Patient's Global Assessment at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Change From Baseline in Physical Component Scores of Short Form (36) Health Survey (SF-36) at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Number and Percentage of Subjects Who Discontinued Prednisone (or Equivalent) by Week 48 Without Experiencing a Severe Flare [Time Frame: Up to and including Week 48]

Number and Percentage of Subjects With mSRI-5 Response at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Number and Percentage of Subjects With Persistent Minimal or no Activity in 9 Organ Systems According to BILAG-2004 Systems Tally at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Number and Percentage of Subjects With mBICLA Response at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Change From Baseline in Creatinine Clearance Estimation (eGFR) at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Number of Subjects Who Were Treatment-emergent Urine Sediment Positive at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Percent Change From Baseline in Daily Dose of Steroids at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Number and Percentage of Subjects Experiencing Severe Flares According to BILAG-2004 Flare Index From Baseline to Week 24 and Week 48 [Time Frame: From Baseline to Week 24 and Week 48]

Number and Percentage of Subjects Experiencing Severe Flares According to mSLEDAI-2K Flare Index (mSFI) From Baseline to Week 24 and Week 48 [Time Frame: From Baseline to Week 24 and Week 48]

Number and Percentage of Subjects With BILAG-2004 Enhanced Improvement at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Number and Percentage of Subjects With Modified Systemic Lupus Erythematosus Responder Index (mSRI-4) Response at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Number and Percentage of Subjects With mSRI-6 Response at Week 24 and Week 48 [Time Frame: At Week 24 and Week 48]

Secondary ID(s)

ALX0061-C204

2015-000372-95

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/02/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02437890