Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants

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• Infections 6,687
• Communicable Diseases 4,452
• Respiratory Syncytial Virus Infections 293

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 1,177 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Part A: Suptavumab 30 mg/kg

  Drug: Suptavumab 30 mg/kg

• Experimental
  Part B: Placebo Matched to Suptavumab

  Drug: Placebo Matched to Suptavumab

• Experimental
  Part B: Suptavumab 30 mg/kg- 1 Dose

  Drug: Suptavumab 30 mg/kg- 1 Dose

• Experimental
  Part B: Suptavumab 30 mg/kg - 2 Doses

  Drug: Suptavumab 30 mg/kg - 2 Doses

Interventions

• DrugSuptavumab 30 mg/kg

  Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.

  Also known as: REGN2222

• DrugPlacebo Matched to Suptavumab

  Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.

• DrugSuptavumab 30 mg/kg- 1 Dose

  Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.

• DrugSuptavumab 30 mg/kg - 2 Doses

  Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.

Primary outcomes

1. Part A: Serum Concentration of Suptavumab Over Time

   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.

   Time frame: Day 1 through Day 150

2. Part B: Percentage of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Infection (Hospitalization or Outpatient Visit With Lower Respiratory Tract Infection [LRTI]) Up to Day 150

   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.

   Time frame: From first study drug administration up to Day 150

Secondary outcomes

1. Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

   Any untoward medical occurrence in participants, who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed/worsened/became serious during on-treatment period (defined as time between the date of first study drug administration \& date of end of study/last visit).Serious AE: Any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious \& non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03(Grade 3 \[severe\] \& Grade 4\[life-threatening\]) was used in this study to grade clinical AEs.

   Time frame: Baseline through Day 150

2. Part B: Serum Concentration of Suptavumab

   Serum samples for drug concentration will be collected at pre-specified time points

   Time frame: Day 29, 57, 85, 113 and Day 150 Post-dose

3. Part B: Number of Participants With At Least One Positive Anti-Drug Antibody (ADA) Assay

   ADA category of each participant was classified as pre-existing immunoreactivity (a positive ADA response at baseline with a \<4-fold increase in titer for all post baseline samples), treatment-boosted (a positive response at baseline with at least one post baseline titer at \>=4-fold the baseline titer), or treatment-emergent (TE \[any positive post baseline assay response when baseline results were negative or missing\]). TE ADA responses were further classified as persistent (treatment-emergent positive ADA response detected in at least 2 consecutive post baseline samples separated by at least a 12-week post baseline period \[based on nominal sampling time\], with no ADA-negative samples in-between, regardless of any missing samples or a positive response at the last ADA sampling time point), indeterminate (a positive assay response at the last collection time point only, regardless of any missing samples), or transient (not persistent/indeterminate, regardless of any missing samples).

   Time frame: Day 1 through Day 150

4. Part B: Percentage of Participants Hospitalized With Medically Attended RSV Infection or Outpatient Visit Lower Respiratory Tract Infection (LRTI) or Upper Respiratory Tract Infection (URTI) Up to Day 150

   A medically attended RSV infection was defined as an infant with a positive RSV test by RT-PCR with any of the following events: -Hospitalized (on the basis of the assessment of the admitting physician) for RSV infection - or Outpatient visit (ER, UC), or pediatric clinic visits \[for either a sick or well visit\]) with RSV 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 or difficulty breathing, and with 1 of the following signs of LRTI, as assessed by a healthcare provider: -Lower chest wall indrawing -Hypoxemia (peripheral capillary oxygen saturation \<95% breathing room air) -Wheezing or crackles. The 150-day efficacy assessment period:first study drug intake through the Day 150 visit.

   Time frame: From the first study drug administration up to Day 150

Baseline characteristics

Publications

• Simoes EAF, Forleo-Neto E, Geba GP, Kamal M, Yang F, Cicirello H, Houghton MR, Rideman R, Zhao Q, Benvin SL, Hawes A, Fuller ED, Wloga E, Pizarro JMN, Munoz FM, Rush SA, McLellan JS, Lipsich L, Stahl N, Yancopoulos GD, Weinreich DM, Kyratsous CA, Sivapalasingam S. Suptavumab for the Prevention of Medically Attended Respiratory Syncytial Virus Infection in Preterm Infants. Clin Infect Dis. 2021 Dec 6;73(11):e4400-e4408. doi: 10.1093/cid/ciaa951. PubMed 32897368 ↗

Study documents

• Study protocol · Apr 11, 2017
• Statistical analysis plan · Aug 9, 2016
• Statistical analysis plan · Jul 28, 2017

Documents are hosted by the registry — open the source record to download them.