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

Ablynx

Status and phase: Completed; Phase 2

Conditions: Lupus Erythematosus, Systemic

Treatments: Biological: Placebo; Biological: ALX-0061

Study type: Interventional

Funder types: Industry

Identifiers

NCT02437890

ALX0061-C204

2015-000372-95 (EudraCT Number)

Details and patient eligibility

About

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 systemic lupus erythematosus (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.

Enrollment: 312 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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312 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Two s.c. injections with placebo every 2 weeks (q2w). \*\*\* Placebo was supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to the placebo group received 2 s.c. injections q2w: Syringe A with placebo (1 mL) q2w starting at Day 1, up to and including Week 46. Syringe B with placebo (0.5 mL) q2w starting at Day 1, up to and including Week 46.

Treatment:

Biological: Placebo

ALX-0061 75 mg q4w

Experimental group

Description:

ALX-0061 75 mg every 4 weeks (q4w). \*\*\* Vobarilizumab (ALX-0061) and placebo were supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to ALX-0061 75 mg q4w received 2 s.c. injections q2w: Syringe A with placebo (1 mL) q2w starting at Day 1, up to and including Week 46. Syringe B with ALX-0061 (0.5 mL) q4w at Day 1, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44, and syringe B with placebo (0.5 mL) q4w at Weeks 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, and 46.

Treatment:

Biological: ALX-0061

Biological: Placebo

ALX-0061 150 mg q4w

Experimental group

Description:

ALX-0061 150 mg every 4 weeks (q4w). \*\*\* Vobarilizumab (ALX-0061) and placebo were supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to ALX-0061 150 mg q4w received 2 s.c. injections q2w: Syringe A with ALX-0061 (1 mL) q4w at Day 1, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44, and syringe A with placebo (1 mL) q4w at Weeks 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, and 46. Syringe B with placebo (0.5 mL) q2w starting at Day 1, up to and including Week 46.

Treatment:

Biological: ALX-0061

Biological: Placebo

ALX-0061 150 mg q2w

Experimental group

Description:

ALX-0061 150 mg every 2 weeks (q2w). \*\*\* Vobarilizumab (ALX-0061) and placebo were supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to ALX-0061 150 mg q2w received 2 s.c. injections q2w: Syringe A with ALX-0061 (1 mL) q2w starting at Day 1, up to and including Week 46. Syringe B with placebo (0.5 mL) q2w starting at Day 1, up to and including Week 46.

Treatment:

Biological: ALX-0061

Biological: Placebo

ALX-0061 225 mg q2w

Experimental group

Description:

ALX-0061 225 mg every 2 weeks (q2w). \*\*\* Vobarilizumab (ALX-0061) was supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to ALX-0061 225 mg q2w received 2 s.c. injections q2w: Syringe A with ALX-0061 (1 mL) q2w starting at Day 1, up to and including Week 46. Syringe B with ALX-0061 (0.5 mL) q2w starting at Day 1, up to and including Week 46.

Treatment:

Biological: ALX-0061