Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of C3G or IC-MPGN.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apellis Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Patients of at least 18 years of age at screening

• Patients must have clinical and pathologic evidence of recurrent C3G or IC-MPGN, as evidenced by all of the following:

• Stable (not improving) or worsening disease, in the opinion of the investigator, in the 2 months preceding the first dose of pegcetacoplan

• eGFR ≥30 mL/min/1.73 m2, calculated by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) creatinine equation for adults

• No more than 50% glomerulosclerosis or interstitial fibrosis on the screening renal allograft biopsy

• Stable regimen for recurrent C3G/IC-MPGN for at least 4 weeks prior to the screening renal allograft biopsy and from the time of the screening renal allograft biopsy until randomization

• Willing to receive vaccinations against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae if applicable vaccination records are not available

Exclusion Criteria:

• Previous treatment with pegcetacoplan

• Evidence of rejection on the screening renal allograft biopsy that requires treatment

• Diagnosis or history of HIV, hepatitis B, or hepatitis C infection or positive serology at screening indicative of infection

• Malignancy, except for the following:

• Cured basal or squamous cell skin cancer

• Curatively treated in situ disease

• Malignancy free and off treatment for ≥5 years

• Significant renal disease in the renal allograft secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, rejection, or a medication) that would confound interpretation of the study results

• Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days or 5 half-lives from the last dose of the investigational agent (whichever is longer) prior to screening