Overview

This trial is active, not recruiting.

Condition lupus erythematosus, systemic
Treatments atacicept 75 mg, atacicept 150 mg
Phase phase 2
Sponsor EMD Serono
Start date July 2014
End date June 2022
Trial size 253 participants
Trial identifier NCT02070978, 2013-002758-62, 700461-024

Summary

This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of atacicept in subjects with systemic lupus erythematosus (SLE). The Week 24 visit of ADDRESS II core trial will coincide with the Day 1 visit of this LTE trial.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
atacicept 75 mg
Subjects who received 75 mg atacicept in the ADDRESS II trial, will continue receiving 75 mg atacicept as subcutaneous injection once weekly for 96 weeks in this trial.
(Experimental)
atacicept 150 mg
Subjects who received placebo or 150 mg atacicept in the ADDRESS II trial, will receive 150 mg atacicept as subcutaneous injection once weekly for 96 weeks in this trial.

Primary Outcomes

Measure
Number of Subjects With at least one Serious Adverse Event (SAE)
time frame: Up to 96 weeks
Number of Subjects Prematurely Discontinuing the treatment due to Adverse Event (AE)
time frame: Up to 96 weeks

Secondary Outcomes

Measure
Change from Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores
time frame: Baseline and Week 96
Change from Baseline in Disease Activity as Measured by British Isles Lupus Assessment Group (BILAG) Score
time frame: Baseline and Week 96
Change from Baseline in Disease Activity as Measured by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score
time frame: Baseline and Week 96
Change from Baseline in Disease Activity as Measured by SLEDAI-2K Responder Index-50 (SRI-50) Score
time frame: Baseline and Week 96
Change from Baseline in Disease Activity as Measured by Physician's Global Assessment (PGA) Score
time frame: Baseline and Week 96
Change from Baseline in SLE Responder Index (SRI) (a Disease Activity Composite Index)
time frame: Baseline and Week 96
Change from Baseline in BILAG-based Combined Lupus Assessment (BICLA) (a Disease Activity Composite Index)
time frame: Baseline and Week 96
Change from Baseline in Prednisone-equivalent Corticosteroid Dose
time frame: Baseline and Week 96
Change from Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36) Score
time frame: Baseline and Week 96
Change from Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score
time frame: Baseline and Week 96
Change from Baseline in Patient Global Impression of Change (PGIC) Score
time frame: Baseline and Week 96
Change from Baseline in EuroQoL 5 Dimension Instrument (EQ-5D) Score
time frame: Baseline and Week 96
Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score
time frame: Baseline and Week 96
Number of Subjects with at least one AE
time frame: Up to 96 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS) Score
time frame: Up to 96 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subjects who have completed the 24-week treatment period of trial EMR-700461-023 (ADDRESS II core trial) - Women of childbearing potential who have a negative pregnancy test - Other protocol defined inclusion criteria could apply Exclusion Criteria: - Active neurological symptoms of SLE that are deemed severe or progressive - Diagnosis of any demyelinating disease, such as, but not restricted to, multiple sclerosis (MS) or optic neuritis - Pregnancy - Active clinically significant viral, bacterial, or fungal infection, or any major episode of infection that in the investigator's opinion makes the subject unsuitable to continue participation in the trial - Other protocol defined exclusion criteria could apply

Additional Information

Official title A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed Protocol EMR-700461-023 (ADDRESS II)
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by EMD Serono.