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RO7303509 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| MAD Stage | EXPERIMENTAL | Participants will be randomized in a ratio of 4:1 to receive RO7303509 or placebo, as subcutaneous (SC) injection, one time per month for 3 months. You have a 20% chance of getting placebo. |
| OSE Stage | EXPERIMENTAL | Every participant in the OSE stage will receive study drug and no participant will receive placebo. Participants will receive RO7303509 as SC injection at the same dose as that administered during the MAD stage, one time per month for up to a year. |
| Name | Type | Description |
|---|---|---|
| RO7303509 | DRUG | RO7303509 will be administered as SC injection monthly, as specified in each treatment group. |
| Placebo | DRUG | RO7303509 matching placebo will be administered as SC injection monthly, during the MAD stage. |
Inclusion Criteria: Inclusion Criteria for the MAD Stage: * Weight of 45-150 kg at screening * Diagnosis of SSc, as defined by 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria and ≤ 10 years disease duration from first non-Raynaud's symptom * Agreemen...
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RO7303509 is an investigational small molecule being studied for the treatment of systemic sclerosis, a chronic autoimmune disease that causes hardening and tightening of the skin and connective tissues. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
RO7303509 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded on the OTC market under the ticker symbol RHHBY. The drug is in Phase 1 clinical trials for systemic sclerosis.
RO7303509 is in Phase 1 clinical development. A Phase 1 study evaluating its safety, tolerability, and pharmacokinetics in participants with systemic sclerosis has been completed. The drug is investigational and has not received regulatory approval.
RO7303509 has one completed clinical trial, identified as NCT05462522. This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of the drug in 56 participants with systemic sclerosis. The trial was conducted across multiple countries, including the United States, Argentina, Belgium, France, Israel, Poland, Portugal, Puerto Rico, Serbia, Spain, and the United Kingdom.
Yes, RO7303509 is a small molecule drug. It is being developed as a potential treatment for systemic sclerosis and is currently in Phase 1 clinical trials. The drug is administered to adult participants aged 18 years and older.