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NCT04981717 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 446
- Enrollment target
NCT04981717 is a Phase 3 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 446 participants.
The verdict
NCT04981717, a Phase 3 study, was terminated before completion, sponsored by Regeneron Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 446 participants
- Enrollment target
Study Summary
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
Interventions
- DRUG Matching Placebo
- DRUG REGN1908-1909
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 446 participants |
| Start Date | 2021-07-30 |
| Est. Completion | 2023-04-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04981717
The ClinicalTrials.gov registry entry for NCT04981717 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 446 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT04981717 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04981717 about?
NCT04981717 is a clinical study titled "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". 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 ...
What is the current status of trial NCT04981717?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 446 participants. The study started on 2021-07-30. Estimated completion is 2023-04-24.
What interventions are being tested in trial NCT04981717?
The interventions under investigation include: Matching Placebo (DRUG), REGN1908-1909 (DRUG).
Who is sponsoring clinical trial NCT04981717?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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