Efficacy and Safety of Atacicept in IgA Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02808429
• Date of registration: 16/06/2016
• Prospective Registration: Yes
• Primary sponsor: EMD Serono Research & Development Institute, Inc.
• Public title: Efficacy and Safety of Atacicept in IgA Nephropathy
• Scientific title: A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy
• Date of first enrolment: January 31, 2017
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02808429
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Germany, Japan, United Kingdom, United States

Contacts

• Name: Medical Responsible
• Affiliation: Merck KGaA, Darmstadt, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- Greater than or equal to (>=)18 years of age

- Biopsy-proven Immunoglobulin (IgA) nephropathy

- Urine Protein to Creatinine Ratio (UPCR) >= 0.75 and <= 6 milligram per milligram
(mg/mg) during screening

- Stable and optimal dose of Angiotensin converting enzyme (ACE) inhibitor and/or
angiotensin II receptor blockers (ARB) at least 8 weeks prior to screening

Exclusion Criteria:

- Concomitant significant renal disease other than IgA nephropathy

- IgA nephropathy with significant glomerulosclerosis or cortical scarring

- Diagnosis of Henoch-Schonlein purpura

- Failure to meet estimated glomerular filtration rate (eGFR) and biopsy requirement
criteria

- Serum IgG below 6 grams per liter (g/L)

- Use of cyclophosphamide ever or use of other immunosuppressants or systemic
corticosteroids within 4 months

- Active infection requiring hospitalization or treatment with parenteral
anti-infectives within 4 weeks

- History, or current diagnosis, of active tuberculosis (TB), or untreated latent TB
infection

- History of or positive HIV and/or positive for hepatitis B or Hepatitis C at screening

- History of malignancy

- Nursing or pregnancy

- Any condition, including any uncontrolled disease state other than IgA nephropathy



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

Health Condition(s) or Problem(s) studied

IgA Nephropathy

Intervention(s)

Drug: Atacicept 25 mg

Drug: Placebo

Drug: Atacicept 75 mg

Primary Outcome(s)

Part B: Percent change from baseline in proteinuria at Week 48 [Time Frame: Baseline and Week 48]

Part A: Proportion of subjects with Adverse events (AE), AEs of special interest (AESIs), serious AEs, AEs leading to discontinuation, and AEs leading to death [Time Frame: Up to 48 weeks]

Secondary Outcome(s)

Part A: Change from baseline levels in serum immunoglobulin (Ig) classes (IgG, IgA, and IgM) [Time Frame: Baseline, up to 96 weeks]

Part A: Proportion of subjects with Clinical significant abnormalities in laboratory assessments, vital signs and electrocardiograms (ECGs) [Time Frame: Up to 96 weeks]

Part A: Serum atacicept concentrations [Time Frame: Baseline, up to 96 weeks]

Part B: Change from baseline levels in serum immunoglobulin (Ig) classes (IgG, IgA, and IgM) [Time Frame: Baseline, up to 180 weeks]

Part B: Change from Baseline in Renal Function [Time Frame: Baseline, Week 156]

Part B: Change from baseline in serum complement C3 and C4 levels [Time Frame: Baseline, up to 180 weeks]

Part B: Proportion of subjects achieving reduction in proteinuria from Baseline and with stable renal function [Time Frame: Baseline, Week 48]

Part A: Proportion of subjects positive for Anti-drug antibody assessment [Time Frame: Up to 96 weeks]

Part B: Change from baseline in serum Galactose Deficient-IgA1 (Gd-IgA1) levels [Time Frame: Baseline, up to 180 weeks]

Part A: Change from baseline in immune cell subsets by flow cytometry analysis [Time Frame: Baseline, up to 96 weeks]

Part A: Change from baseline in serum Galactose Deficient-IgA1 (Gd-IgA1) levels [Time Frame: Baseline, up to 96 weeks]

Part B: Change in urine immuno-electrophoresis pattern [Time Frame: Baseline, up to 180 weeks]

Part B: Proportion of subjects with AEs, AESIs, AEs leading to discontinuation, SAEs, AEs leading to death [Time Frame: Up to 180 weeks]

Part B: Proportion of subjects positive for Anti-drug antibody assessment [Time Frame: Up to 180 weeks]

Part A: Change from baseline in serum complement C3 and C4 levels [Time Frame: Baseline, up to 96 weeks]

Part A: Change in urine immuno-electrophoresis pattern [Time Frame: Baseline, up to 96 weeks]

Part B: Change from baseline in immune cell subsets by flow cytometry analysis [Time Frame: Baseline, up to 180 weeks]

Part B: Proportion of subjects with Clinical significant Abnormalities in laboratory assessments, vital signs and electrocardiograms (ECGs) [Time Frame: Up to 180 weeks]

Part B: Serum atacicept concentrations [Time Frame: Baseline, up to 180 weeks]

Secondary ID(s)

MS700461-0035

2016-002262-31

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck KGaA, Darmstadt, Germany