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

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ClinicalTrials.gov Identifier: NCT02437890
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ablynx

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.


Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Biological: ALX-0061 Biological: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Severe Active Systemic Lupus Erythematosus
Study Start Date : July 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Placebo Comparator: Group 1
Placebo, at week 0 and every 2 weeks thereafter up to and including week 46
Biological: Placebo
Experimental: Group 2

ALX-0061 Dose A at week 0 and every 4 weeks thereafter up to and including Week 44.

Placebo at week 0 and every 2 weeks thereafter up to and including week 46

Biological: ALX-0061
Biological: Placebo
Experimental: Group 3

ALX-0061 Dose B at week 0 and every 4 weeks thereafter up to and including Week 44.

Placebo at week 0 and every 2 weeks thereafter up to and including week 46.

Biological: ALX-0061
Biological: Placebo
Experimental: Group 4

ALX-0061 Dose B at Week 0 and every 2 weeks thereafter up to and including Week 46.

Placebo at week 0 and every 2 weeks thereafter up to and including week 46.

Biological: ALX-0061
Biological: Placebo
Experimental: Group 5
ALX-0061 Dose C at Week 0 and every 2 weeks thereafter up to and including Week 46.
Biological: ALX-0061



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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

  2. The change from baseline in patient's global assessment over time. [ Time Frame: Week 48 ]
  3. The change from baseline in renal parameters [ Time Frame: Week 48 ]
  4. The percentage of patients experiencing a treatment failure [ Time Frame: Week 24 and Week 48. ]
  5. 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

  6. The change from baseline in corticosteroids use [ Time Frame: Week 24 - Week 48 ]
  7. The change from baseline in the physical and mental component scores of SF-36 [ Time Frame: Week 24 and Week 48 ]
  8. Change from baseline in joints count over time [ Time Frame: Week 48 ]
  9. The change from baseline of Cutaneous lupus erythematosus disease area and severity index (CLASI) [ Time Frame: Week 12, Week 24 and Week 48 ]
  10. The determination of ALX-0061 in blood samples (composite) [ Time Frame: Week 12, Week 24 and Week 48 ]
  11. The determination of biomarkers in blood samples [ Time Frame: Week 60 ]
  12. The determination of anti-ALX-0061 antibodies in blood samples (composite) [ Time Frame: Week 60 ]
  13. The incidence of adverse events and serious adverse events. [ Time Frame: Week 60 ]
  14. The change from baseline in clinical laboratory parameters (composite) [ Time Frame: Week 60 ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

3. Any active or recurrent viral infection that based on the Investigator´s clinical assessment makes the subject unsuitable for the study 4. Have received prior therapy blocking the IL-6 pathway 5. Others as defined in the protocol


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437890


  Show 117 Study Locations
Sponsors and Collaborators
Ablynx
Investigators
Study Director: Medical Lead Ablynx NV

Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT02437890     History of Changes
Other Study ID Numbers: ALX0061-C204
2015-000372-95 ( EudraCT Number )
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases