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Also known as Romilkimab
SAR156597 · 3 trials · 2 indications
mRSS, an accepted clinical measure of the skin thickness (fibrosis). Investigator physicians or qualified medical personnel assessed the thickening of skin in 17 skin sites including fingers, hands, forearms, arms, feet, legs and thighs, face, chest and abdomen. Each skin site was rated on a 0-3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness and 3 = severe thickness. Total mRSS ranged from 0 (no thickening) to 51 (severe thickening in all 17 areas), where higher score indicated more severity of skin thickening/worst outcome.
FVC is a standard pulmonary function parameter measured by spirometry and used to quantify respiratory capacity (inspiration and expiration). It is a widely used objective measure of disease status in participants with Idiopathic Pulmonary Fibrosis (IPF). The primary variable was recorded as percent (%) of predicted value, which takes into account the height, gender, and age of the participant. The outcome measure measured the change in lung function from baseline at week 52.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo (for SAR156597), single subcutaneous (SC) injection once in a week (QW) up to Week 24. |
| SAR156597 | EXPERIMENTAL | SAR156597 200 milligram (mg), single SC injection QW up to Week 24. |
| Placebo qw | PLACEBO_COMPARATOR | Participants received one injection of placebo (matched to SAR156597) subcutaneously once every week (qw) for 52 weeks. |
| SAR156597 200 mg q2w | EXPERIMENTAL | Participants received one injection of SAR156597 200 mg subcutaneously once every 2 weeks (q2w) alternating with placebo (matched to SAR156597) for 52 weeks. |
| SAR156597 200 mg qw | EXPERIMENTAL | Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks. |
| SAR156597 dose 1 | EXPERIMENTAL | SAR156597 dose 1, subcutaneous injection once every week |
| SAR156597 dose 2 | EXPERIMENTAL | SAR156597 dose 2, subcutaneous injection once every week |
| SAR156597 dose 3 | EXPERIMENTAL | SAR156597 dose 3, subcutaneous injection once every week |
| Name | Type | Description |
|---|---|---|
| SAR156597 | DRUG | Pharmaceutical form: Solution Route of administration: Subcutaneous |
| Placebo | DRUG | Pharmaceutical form: Solution Route of administration: Subcutaneous |
| Placebo (for SAR156597) | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
Inclusion criteria : * Systemic Sclerosis (SSc) according to the American College of Rheumatology/The European League against Rheumatism (ACR/EULAR) 2013 criteria. * Diffused cutaneous form of SSc according to Leroy's criteria. * Able and willing to sign the written informed consent form with compr...
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SAR156597 is an investigational biologic drug developed by Sanofi for respiratory and fibrotic diseases. It has been studied in Phase 2 clinical trials for idiopathic pulmonary fibrosis and diffuse systemic sclerosis. It is a bispecific antibody that binds IL4 and IL13, two cytokines involved in inflammation and fibrosis. It is not approved for any indication.
SAR156597 was studied as a treatment for idiopathic pulmonary fibrosis, a progressive scarring disease of the lungs. A Phase 2 trial, NCT02345070, evaluated its efficacy and safety in 327 patients with IPF. A smaller Phase 1 study, NCT01529853, examined different doses in 24 IPF patients. Both trials are completed.
SAR156597 targets IL4 and IL13, two signaling proteins that drive inflammation and tissue fibrosis. It is a bispecific monoclonal antibody designed to block both targets simultaneously. By neutralizing IL4 and IL13 activity, the drug aims to reduce the fibrotic and inflammatory processes underlying conditions such as idiopathic pulmonary fibrosis and systemic sclerosis.
SAR156597 is developed by Sanofi, the French pharmaceutical company whose shares trade under the ticker SNY. Sanofi sponsored the clinical trials evaluating the drug in idiopathic pulmonary fibrosis and diffuse systemic sclerosis. No partnership or licensing arrangement for SAR156597 is disclosed in the available trial records.
SAR156597 is in Phase 2 development. Two Phase 2 trials have been completed: NCT02345070 in idiopathic pulmonary fibrosis and NCT02921971 in diffuse systemic sclerosis. A Phase 1 dose study, NCT01529853, was also completed. SAR156597 is investigational and has not been approved by the FDA for any indication.
SAR156597 has been evaluated in three completed trials. NCT02345070 was a Phase 2 study of 327 patients with idiopathic pulmonary fibrosis. NCT02921971 was a Phase 2 study of 97 patients with diffuse systemic sclerosis. NCT01529853 was a Phase 1 dose evaluation in 24 patients with idiopathic pulmonary fibrosis.