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SAR100842 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SAR100842 | EXPERIMENTAL | Core part: SAR100842 300 mg, oral administration twice daily, for 8 weeks Extension part: SAR100842 300 mg, oral administration twice daily, for 16 additional weeks |
| Placebo | PLACEBO_COMPARATOR | Core part: Placebo (for SAR100842), oral administration twice daily, for 8 weeks Extension part: SAR100842 300 mg, oral administration twice daily, for 16 additional weeks |
| Name | Type | Description |
|---|---|---|
| SAR100842 | DRUG | Pharmaceutical form: tablets Route of administration: oral |
| Placebo (for SAR100842) | DRUG | Pharmaceutical form: tablets Route of administration: oral |
Inclusion criteria : \- Patients who meet the American College of Rheumatology (ACR) criteria for systemic sclerosis with diffuse cutaneous involvement and \<36 months since the onset of the first systemic sclerosis manifestation other than Raynaud's phenomenon and have a Modified Rodnan Skin Score...
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SAR100842 is an investigational small molecule being studied for the treatment of systemic sclerosis, a chronic autoimmune disease characterized by fibrosis of the skin and internal organs. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
SAR100842 is a small molecule developed by Sanofi. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being investigated for its potential to modulate biological pathways involved in systemic sclerosis, but the exact mechanism of action is not publicly detailed.
SAR100842 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical research to evaluate the safety and efficacy of SAR100842 in patients with systemic sclerosis.
SAR100842 is in Phase 2 clinical development. A Phase 2 trial has been completed, but the drug remains investigational and has not received regulatory approval. Further studies may be needed to establish its safety and efficacy before it can be considered for marketing authorization.
SAR100842 has been evaluated in one completed Phase 2 clinical trial with the identifier NCT01651143, titled 'Proof of Biological Activity of SAR100842 in Systemic Sclerosis'. This randomized, double-blind, placebo-controlled study enrolled 32 participants across the United States, France, Italy, Switzerland, and the United Kingdom.
No alternative names for SAR100842 have been identified in available clinical trial records. The drug is exclusively referred to as SAR100842 in the context of its development by Sanofi for systemic sclerosis. No other brand names or aliases are currently associated with this investigational compound.