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

NCT02070978 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2019-03-21

Study results available
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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 participants with systemic lupus erythematosus (SLE). Participants who completed the 24-week core study ADDRESS II core study (NCT01972568) and thus not met any of the discontinuation criteria were invited to enter this long-term extension (LTE) study NCT02070978.

Conditions

  • Lupus Erythematosus, Systemic

Interventions

DRUG

Atacicept 75 mg

Participants who received atacicept 75 milligram (mg) as once-weekly subcutaneous injection in the core study ADDRESS II continued to receive this dose during this LTE study. Participants in this reporting arm received the medication up to a maximum of 143.7 weeks.

DRUG

Atacicept 150 mg

Participants who received placebo in the core study ADDRESS II switched to receive atacicept 150 mg as once-weekly subcutaneous injection for up to a maximum of 97.7 weeks during this LTE study.

DRUG

Atacicept 150 mg

Participants who received atacicept 150 mg in core study ADDRESS II continued to receive atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.9 weeks.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-29
Primary Completion
2016-04-05
Completion
2018-02-09

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Chile
  • Czechia
  • Germany
  • Italy
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02070978 on ClinicalTrials.gov