NCT02127801

Brief Summary

The purposes of this study are to assess the efficacy, safety and tolerability of a single dose of REGN1908-1909 in allergic adult participants, to collect information about how much REGN1908-1909 is in blood over time and to collect information about how the body reacts to REGN1908-1909.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2014

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

October 31, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

1.2 years

First QC Date

April 29, 2014

Last Update Submit

December 11, 2020

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

  • Change in allergic symptom scale score

    The primary endpoint is the change in allergic symptom scale score at day 8

    At day 8

Secondary Outcomes (2)

  • Incidence rate of treatment-emergent adverse events (TEAEs) through day 85 in participants treated with REGN1908-1909 or placebo

    day 1 to day 85

  • Pharmacokinetic (PK) parameters of REGN1908- REGN1909 administration (i.e. how much REGN1908-1909 is in blood over time and how the body reacts to REGN1908-1909)

    day 1 to day 85

Study Arms (2)

Group A

EXPERIMENTAL

Participants in group A will receive REGN1908-1909

Drug: REGN1908-1909

Group B

EXPERIMENTAL

Participants in group B will receive placebo

Drug: placebo

Interventions

REGN1908-1909DRUG
Group A
placeboDRUG
Group B

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women between the ages of 18 and 55
  • Positive allergen skin prick test
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent

You may not qualify if:

  • Persistent, chronic, or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit
  • Any clinically significant (determined at the investigator's discretion) abnormalities observed during the screening physical examination
  • Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to the screening visit. Patients must be willing to maintain a similar level of exercise for the duration of the study and to refrain from unusually strenuous exercise for the duration of the trial
  • Hospitalization for any reason within 60 days prior to the screening visit
  • Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) of the investigational drug prior to the screening visit
  • Any medical or psychiatric condition that in the opinion of the investigator or Regeneron, would place the patient at risk, interfere with participation in the study or interfere with the interpretation of study results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Groningen, Netherlands

Location

Unknown Facility

Auckland, New Zealand

Location

Unknown Facility

Christchurch, New Zealand

Location

Unknown Facility

Lund, Sweden

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (1)

  • Shamji MH, Singh I, Layhadi JA, Ito C, Karamani A, Kouser L, Sharif H, Tang J, Handijiev S, Parkin RV, Durham SR, Kostic A, Orengo JM, DeVeaux M, Kamal M, Stahl N, Yancopoulos GD, Wang CQ, Radin AR. Passive Prophylactic Administration with a Single Dose of Anti-Fel d 1 Monoclonal Antibodies REGN1908-1909 in Cat Allergen-induced Allergic Rhinitis: A Randomized, Double-Blind, Placebo-controlled Clinical Trial. Am J Respir Crit Care Med. 2021 Jul 1;204(1):23-33. doi: 10.1164/rccm.202011-4107OC.

    PMID: 33651675DERIVED

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2014

First Posted

May 1, 2014

Study Start

October 31, 2014

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

December 16, 2020

Record last verified: 2020-12

Locations

NL(1)NZ(2)SE(1)GB(1)