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Also known as Sefaxersen (RO7434656)
Sefaxersen · 1 trial · 1 indication
UPCR will be assessed in urine sampled over 24 hours.
| Arm | Type | Description |
|---|---|---|
| Sefaxersen (RO7434656) | EXPERIMENTAL | 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. |
| Placebo | PLACEBO_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Sefaxersen (RO7434656) | DRUG | Sefaxersen (RO7434656) will be administered as SC injection per schedule as specified in the protocol. |
| Placebo | DRUG | Matching placebo will be administered as SC injection per schedule as specified in the protocol. |
Inclusion Criteria: * Primary IgAN, as evidenced by a kidney biopsy performed within 10 years prior to or during screening, without known secondary cause * Treatment with maximum tolerated doses of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) for at leas...
Sefaxersen is an investigational RNA therapy being developed by Roche Holding AG for primary IgA nephropathy, a kidney disease. It is also known as RO7434656. Sefaxersen is currently in Phase 3 clinical development and has not been approved by the FDA.
Sefaxersen is being evaluated for the treatment of primary immunoglobulin A (IgA) nephropathy in adults at high risk of disease progression. It is an investigational therapy and is not yet approved for any indication. Its safety and efficacy are being assessed in a Phase 3 clinical trial.
Sefaxersen is an antisense oligonucleotide, part of the -sen RNA therapy class. Antisense oligonucleotides are designed to bind RNA and modulate the production of specific proteins. Roche is developing sefaxersen as an RNA therapy for primary IgA nephropathy.
Sefaxersen is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is running the clinical development program for sefaxersen, also known as RO7434656, in primary IgA nephropathy.
Sefaxersen is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 3 trial is currently active but not recruiting participants.
Sefaxersen is being studied in one Phase 3 trial, NCT05797610, titled a study to evaluate the efficacy and safety of sefaxersen (RO7434656) in participants with primary IgA nephropathy at high risk of progression. The trial has enrolled 459 participants, is randomized, double-blind, and placebo-controlled, and is active but not recruiting.
Yes, sefaxersen and RO7434656 are the same investigational drug. RO7434656 is Roche's internal compound code for sefaxersen, and both names refer to the same RNA therapy being studied in primary IgA nephropathy.