VALIANT

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

• IRAS ID

  301477

• Contact name

  Patrick Murphy

• Contact email

  patrick.murphy@apellis.com

• Sponsor organisation

  Apellis Pharmaceuticals, Inc.

• Eudract number

  2020-003767-25

• Clinicaltrials.gov Identifier

  NCT05067127

• Clinicaltrials.gov Identifier

  136409, IND

• Duration of Study in the UK

  2 years, 8 months, 17 days

• Research summary

  The safety and effectivenesss of taking pegcetacoplan (study medicine) compared to placebo, for participants with complement 3 glomerulopathy (C3G) or immune-complex mediated membranoproliferative glomerulonephritis (IC-MPGN), will be studied in this Clinical Trial.

  Approximately 80 to 100 participants, aged 12 to 17yrs will participate globally.

  The Trial is divided into the below periods:

  • Screening period
  • Placebo-controlled, double-blinded, randomised treatment period – In this period, participants will have a 50% chance of receiving either pegcetacoplan or placebo, based on a random computer assignment.
  • Open-Label Treatment Period – In this phase, all participants will receive pegcetacoplan
  • Follow-up period (to check your overall health and safety)

  The study medicine will be administered under the skin in 30-minute infusions, twice a week. Side effects will be monitored throughout the study.

  Participation in the study will last up to approximately 68 weeks. Participation is voluntary.

  If the study doctor determines that participants are experiencing clinical benefit following the Open-label treatment period they may later be enrolled into an extension study to continue receiving study medicine.

  Participants will be expected to attend clinic visits whereby study assessments will take place e.g. blood and urine collection, kidney biopsy, chest x-ray, physical examinations, vital signs, completion of questionnaires and diaries.

  Lay summary of each trial could be found on the website: https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2024-514130-20-00.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  21/NW/0338

• Date of REC Opinion

  18 Jan 2022

• REC opinion

  Further Information Favourable Opinion