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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, when approximately 230 participants in the primary cohort have completed the Week 105 visit. |
| 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, when approximately 230 participants in the primary cohort have completed the Week 105 visit. |
| Name | Type | Description |
|---|---|---|
| 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. |
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 small molecule antisense oligonucleotide being developed for the treatment of primary IgA nephropathy, a kidney disease. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Sefaxersen is an antisense oligonucleotide (ASO), a class of drugs that work by targeting and modulating the expression of specific genes. As an ASO, it is designed to interfere with the production of disease-related proteins, though the specific molecular target has not been disclosed.
Sefaxersen is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market.
Sefaxersen is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients with primary IgA nephropathy.
Sefaxersen is being studied in a Phase 3 clinical trial with the identifier NCT05797610. This randomized, double-blind, placebo-controlled study evaluates the efficacy and safety of Sefaxersen in participants with primary IgA nephropathy at high risk of progression. The trial is active but not recruiting and has an enrollment of 459 participants.
Yes, Sefaxersen is also known as RO7434656. Both names refer to the same investigational drug being developed by Roche for the treatment of primary IgA nephropathy.