A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Allergic Rhinitis Due to Cat Allergy
In brief
The primary objective of the study is to determine the efficacy of REGN1908-1909, as compared to placebo, to reduce allergic rhinitis/conjunctivitis symptoms and allergy rescue medication use during natural cat exposure. The Secondary Objectives are: * To assess the reduction of allergic symptoms and use of allergy rescue medications after treatment with REGN1908-1909 versus placebo, as measured by the individual components of the CSMS * To assess health-related quality of life (HRQoL) as measured by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ\[S\]) * To determine the efficacy of REGN1908-1909, as compared to placebo, to inhibit a wheal-and-flare response to a skin prick test with cat allergen * To assess the durability of effect in allergic rhinitis and conjunctivitis symptom and medication scores after multiple doses of REGN1908-1909 compared to placebo given every 12 weeks (Q12W) * To determine the efficacy following multiple doses of REGN1908-1909 compared to placebo at inhibiting a wheal-and-flare response to a skin prick test with cat allergen * To estimate the effect of REGN1908-1909 on lung function, as compared to placebo, in patients with asthma * To determine the efficacy of REGN1908-1909 as compared to placebo to reduce asthma symptoms in patients with asthma * To assess whether there is a difference in asthma rescue medication use in patients with asthma who are treated with REGN1908-1909 compared to placebo * To assess whether there is a difference in nighttime awakenings in patients with asthma treated with REGN1908-1909 compared to placebo * To evaluate the short-term and long-term safety and tolerability of REGN1908-1909, including the incidence of hypersensitivity reactions, local injection site reactions, and asthma exacerbations * To determine systemic exposure of total (free and antigen-bound) antibodies as measured by concentration of REGN1908 and REGN1909 * To assess the immunogenicity of REGN1908 and REGN1909
Key facts
- Study ID
- NCT04981717
- Run by
- Regeneron Pharmaceuticals
- People needed
- 446
- Starts
- 2021-07-30
- Expected to finish
- 2023-04-24
- Last updated by the study team
- 2024-06-11
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Integrated Research of Inland, Inc — Riverside, California, United States
- Peninsula Research Associates - CRN - PPDS — Rolling Hills Estates, California, United States
- Allergy and Asthma Medical Group and Research Center - CRN - PPDS — San Diego, California, United States
- Asthma and Allergy Associates PC - CRN - PPDS — Colorado Springs, Colorado, United States
- Colorado Allergy and Asthma Centers PC - CRN - PPDS — Denver, Colorado, United States
- Emory University — Atlanta, Georgia, United States
- Velocity Clinical Research, Inc. (Meridan) — Meridian, Idaho, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Asthma and Allergy Center of Chicago Sc-Oak Park — Oak Park, Illinois, United States
- Sneeze Wheeze and Itch Associates LLC — Springfield, Illinois, United States
- South Bend Clinic — South Bend, Indiana, United States
- Bluegrass Allergy Research — Lexington, Kentucky, United States
- Allergy and Asthma Specialists PSC — Owensboro, Kentucky, United States
- Charleston Allergy and Asthma — Baltimore, Maryland, United States
- Institute For Asthma and Allergy — Chevy Chase, Maryland, United States
- Respiratory Medicine Research Institute of Michigan PLC — Ypsilanti, Michigan, United States
- Clinical Research Institute, Inc - CRN - PPDS — Plymouth, Minnesota, United States
- University of Missouri - Hospital — Columbia, Missouri, United States
- Montana Medical Research — Missoula, Montana, United States
- Somnos Clinical Research — Lincoln, Nebraska, United States
- Nebraska Medical Research Institute, Inc. - CRN - PPDS — Papillion, Nebraska, United States
- Riverside Medical Group - Circuit - PPDS — Belleville, New Jersey, United States
- Atlantic Research Center LLC — Ocean City, New Jersey, United States
- Princeton Center For Clinical Research - CRN - PPDS — Skillman, New Jersey, United States
- Allergy and Asthma Associates of Southern California - CRN - PPDS — Mission Viejo, California, United States
Full record on ClinicalTrials.gov
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