Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02070978
• Date of registration: 21/02/2014
• Prospective Registration: Yes
• Primary sponsor: EMD Serono
• Public title: Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)
• Scientific 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)
• Date of first enrolment: July 29, 2014
• Target sample size: 253
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02070978
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Argentina, Brazil, Bulgaria, Chile, Czechia, Germany, Italy, Korea, Republic of, Mexico, Peru, Philippines, Poland, Russian Federation, South Africa, Spain, United Kingdom, United States

Contacts

• Name: Medical Responsible
• Affiliation: EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants who had completed the 24-week treatment period of study EMR-700461-023
(ADDRESS II core trial)

- Women of childbearing potential who had a negative pregnancy test

- Other protocol defined inclusion criteria were applied

Exclusion Criteria:

- Active neurological symptoms of SLE that were 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 participants
unsuitable to continued participation in the study

- Other protocol defined exclusion criteria were applied



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Intervention(s)

Drug: Atacicept 75 mg

Drug: Atacicept 150 mg

Primary Outcome(s)

Number of Participants Who Prematurely Discontinued the Treatment Due to Adverse Event (AE) [Time Frame: Baseline (Day 1 of Core study) up to maximum duration of 167.7 weeks]

Number of Participants With at Least One Serious Adverse Event (SAE) During the Treatment Period [Time Frame: Baseline (LTE Day 1) up to maximum treatment duration of 143.7 weeks]

Secondary Outcome(s)

Number of Participants With at Least One Adverse Event [Time Frame: Baseline (Day 1 of Core study) up to maximum duration of 167.7 weeks]

Change From Baseline in Disease Activity as Measured by SLEDAI-2K Responder Index-50 (SRI-50) Score [Time Frame: Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96]

Change From Baseline in EuroQoL 5 Dimension Instrument (EQ-5D) Score [Time Frame: Baseline: Day 1 (Core Study), LTE Day 1, Week 24, Week 48, Week 72 and Week 96]

Change From Baseline in Disease Activity as Measured by British Isles Lupus Assessment Group (BILAG) 2004 Score [Time Frame: Baseline: Core study Screening, LTE Day 1, Week 24, Week 48, Week 72 and Week 96]

Percent Change From Baseline in Prednisone-equivalent Corticosteroid Dose [Time Frame: Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96]

Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score [Time Frame: Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72, 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: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96]

Number of Participants Who Achieved SLE Responder Index (SRI-4) Response (a Disease Activity Composite Index) [Time Frame: Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96]

Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores [Time Frame: Baseline: Day 1 (Core Study), LTE Day 1, Week 24, Week 48, Week 72 and Week 96]

Number of Participants With Columbia-Suicide Severity Rating Scale (C-SSRS) Score [Time Frame: LTE Day 1, Week 24, Week 48, Week 72 and Week 98]

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score [Time Frame: Baseline: Day 1 (Core study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96]

Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores [Time Frame: Baseline: Day 1 (Core Study), Day 1 (LTE Study), Week 24, Week 48, Week 72 and Week 96]

Number of Participants Who Achieved BILAG-based Combined Lupus Assessment (BICLA) Response (a Disease Activity Composite Index) [Time Frame: Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96]

Number of Participants With Patient Global Impression of Change (PGIC) [Time Frame: Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72 and Week 96]

Change From Baseline in Disease Activity as Measured by Physician's Global Assessment (PGA) Score [Time Frame: Baseline: Screening Visit (Core Study); LTE Day1, Week 24, Week 48, Week 72 and Week 96]

Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score [Time Frame: Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72 and Week 96]

Secondary ID(s)

700461-024

2013-002758-62

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02070978