Atacicept Demonstrating Dose RESponSe

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01440231
• Date of registration: 22/09/2011
• Prospective Registration: Yes
• Primary sponsor: EMD Serono
• Public title: Atacicept Demonstrating Dose RESponSe ADDRESS
• Scientific title: A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Dose-Response Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)
• Date of first enrolment: February 2012
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01440231
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Stephen Wax, MD, PhD
• Affiliation: EMD Serono, Senior Medical Director, Rheumatology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female of =18 years of age

- Written informed consent

- Diagnosis of SLE satisfying at least 4 out of the 11 ACR criteria during the course
of their illness

- Disease duration of at least 6 months

- SLEDAI-2K score = 6 at screening

- Positive test results for antinuclear antibody (ANA) (HEp-2 ANA =1:80) and/or
anti-double-stranded deoxyribonucleic acid (dsDNA) (=30 IU/mL) at screening

- Negative serum pregnancy test and highly effective method of contraception for woman
of childbearing potential.

Exclusion Criteria:

- Increase in dosing of corticosteroids within 2 weeks prior to screening

- Introduction of MMF within 3 months prior to TD1 or increase in dosing within 1 month
before screening

- Change in dosing of immunosuppressants or corticosteroids during the screening period

- Serum IgG < 6g/L

- Estimated Glomerular Filtration Rate (GFR) <50 mL/min/1.73m²

- Urinary protein:creatinine ratio >2 mg/mg

- History of demyelinating disease

- Breastfeeding or pregnancy

- Legal or limited legal capacity

Additional exclusion criteria also apply



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

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Atacicept

Drug: Placebo

Primary Outcome(s)

Change from baseline (trial day 1) in SLEDAI-2K Responder Index-50 (SRI-50) at week 24 of therapy [Time Frame: 24 weeks]

Secondary Outcome(s)

Change from baseline in anti-dsDNA antibodies (in subjects with anti dsDNA =30 IU/mL at baseline) and in ANA levels (in subjects with HEp-2 ANA =1:80 at baseline) at week 24 [Time Frame: 24 weeks]

Change from baseline in serum Complement C3 levels at week 24 in subjects with low C3 at baseline [Time Frame: 24 weeks]

Change from baseline in levels of total Ig and Ig classes (IgG, IgA, and IgM) at week 24 [Time Frame: 24 weekls]

Change from baseline to Week 24 in corticosteroid dose [Time Frame: 24 weeks]

Change from baseline in serum Complement C4 levels at week 24 in subjects with low C4 at baseline [Time Frame: 24 weeks]

The nature (preferred terms) and incidence of AEs [Time Frame: 24 weeks]

Secondary ID(s)

BB-IND 11,584

EMR 700461-018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors