A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

Conditions

• Primary IgA Nephropathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sefaxersen (RO7434656) — DRUG
  Sefaxersen (RO7434656) will be administered as SC injection per schedule as specified.
• Placebo — DRUG
  Matching placebo will be administered as SC injection per schedule as specified.

Study Details

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of sefaxersen (RO7434656), a novel Antisense Oligonucleotide (ASO) therapy in participants with primary IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite optimized supportive care.

Key Dates

First listed

Apr 4, 2023

Start date

Aug 8, 2023

Status verified

Jun 2026

Primary completion

Aug 31, 2026

Completion

Mar 31, 2029

Study Design

Enrollment

428 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sefaxersen (RO7434656)
  Participants will receive subcutaneous (SC) doses of sefaxersen (RO7434656) on Days 1, 15, and 29 followed by once every 4 weeks (Q4W) until Week 105. Participants may be eligible to switch to open-label treatment after Week 105 at the investigator's discretion or after the common-close timepoint, whichever occurs first. The common-close timepoint is defined as the data cut-off date for the primary analysis, when approximately 230 participants in the primary cohort have completed the Week 105 visit.
• Placebo Comparator: Placebo
  Participants will receive SC doses of sefaxersen (RO7434656) matching placebo on Days 1, 15, and 29 followed by once Q4W until Week 105. Participants may be eligible to switch to open-label treatment after Week 105 at the investigator's discretion or after the common-close timepoint, whichever occurs first. The common-close timepoint is defined as the data cut-off date for the primary analysis, when approximately 230 participants in the primary cohort have completed the Week 105 visit.

Primary Outcome Measure

Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37 [ Time Frame: Baseline, Week 37 ]

Central Contacts

• Reference Study ID Number: WA43966 https://forpatients.roche.com/
  888-662-6728 (U.S. Only)
  [email protected]
• Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (40)

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