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Suptavumab/kg · 1 trial · 1 indication
Part A was primarily designed to determine the pharmacokinetics (PK) of suptavumab in infants to inform the dose regimen used in Part B of the study. The study protocol specified the process and criteria for assessment of the dose. The dose used in Part B was to remain the same as Part A if the PK data up to Day 57 demonstrated that the individual PK observations were consistent with model-predicted concentrations, following age and body weight corrections.
A medically attended RSV infection defined as an infant with positive RSV test by Reverse-transcriptase polymerase chain reaction (RT-PCR) with any of following events: Hospitalized (on basis of assessment of admitting physician) for RSV infection or outpatient visit (emergency room \[ER\], urgent care \[UC\], or pediatric clinic visits \[for either a sick or well visit\]) with RSV lower respiratory tract infection (LRTI). An RSV LRTI in an infant: RSV proven respiratory infection (i.e positive RSV RT-PCR test) with parent(s)/guardian(s) report of cough/difficulty breathing, \& with 1 of following signs of LRTI, as assessed by healthcare provider: - lower chest wall in drawing -hypoxemia (peripheral capillary oxygen saturation \<95% breathing room air) - Wheezing/crackles. The 150-day efficacy assessment period: first study drug intake through the Day 150 visit.
| Arm | Type | Description |
|---|---|---|
| Part A: Suptavumab 30 mg/kg | EXPERIMENTAL | - |
| Part B: Placebo Matched to Suptavumab | EXPERIMENTAL | - |
| Part B: Suptavumab 30 mg/kg- 1 Dose | EXPERIMENTAL | - |
| Part B: Suptavumab 30 mg/kg - 2 Doses | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Suptavumab 30 mg/kg | DRUG | Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1. |
| Placebo Matched to Suptavumab | DRUG | Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57. |
| Suptavumab 30 mg/kg- 1 Dose | DRUG | Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57. |
| Suptavumab 30 mg/kg - 2 Doses | DRUG | Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57. |
Key Inclusion Criteria: 1. Preterm, otherwise healthy male or female infant who is ≤6 months of age at the time of the first dose (i.e., infant must be treated on or before their 6 month birthday) 2. Gestational age is ≤35 weeks, 6 days at birth 3. Parent(s) or legal guardian(s) of the infant is ab...
Suptavumab/kg is an investigational drug being studied for the prevention of medically attended Respiratory Syncytial Virus (RSV) infection in preterm infants. It is being developed as a preventive treatment for RSV, a common respiratory virus that can cause serious illness in young children.
Suptavumab/kg is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. Regeneron is conducting clinical research to evaluate the safety and efficacy of this drug for preventing RSV infection in preterm infants.
Suptavumab/kg is in Phase 3 clinical development. It has completed a Phase 3 trial, but it is still investigational and has not been approved by regulatory authorities. The drug is being evaluated for its efficacy and safety in preventing medically attended RSV infection in preterm infants.
Suptavumab/kg has been studied in one completed Phase 3 clinical trial, identified as NCT02325791. This trial, titled 'Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV Infection in Preterm Infants,' enrolled 1,177 participants across multiple countries including the United States, Australia, and several European nations.
Yes, Suptavumab/kg is also known as REGN2222. In the clinical trial NCT02325791, the drug is referred to as Suptavumab (REGN2222), indicating that these names refer to the same investigational compound being developed by Regeneron Pharmaceuticals for the prevention of RSV infection.
Suptavumab/kg has completed a Phase 3 clinical trial, but it remains investigational and is not yet approved. The completed trial was a randomized, double-blind, controlled study with 1,177 participants, evaluating the drug's efficacy and safety in preventing medically attended RSV infection in preterm infants.