NCT04981717

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

Terminated Phase 3 Results posted Last updated 11 June 2024

What this trial tests

Phase 3 trial testing REGN1908-1909 in Allergic Rhinitis Due to Cat Allergy in 446 participants. Terminated before completion.

Timeline

30 July 2021

Primary endpoint
4 January 2023

24 April 2023

Quick facts

Lead sponsor	Regeneron Pharmaceuticals
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	446
Start date	30 July 2021
Primary completion	4 January 2023
Estimated completion	24 April 2023
Sites	92 locations across France, Belgium, Germany, Poland, Canada, United States

Drugs / interventions tested

• REGN1908-1909 — full drug profile →
• Matching Placebo — full drug profile →

Conditions studied

• Allergic Rhinitis Due to Cat Allergy — all drugs for Allergic Rhinitis Due to Cat Allergy →

Sponsor

Regeneron Pharmaceuticals — full company profile →

Who can join

12 and older, any sex, with Allergic Rhinitis Due to Cat Allergy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Daily CSMS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo Secondary · Weeks 0 to 12

The combined symptom and medication score (CSMS) is defined as the daily combined allergic rhinitis and conjunctivitis total symptom score (TSS: calculated as the sum of total nasal symptom score \[TNSS\] and total ocular symptom score \[TOSS\]) plus daily medication score (DMS). Scores ranging between 0 (none) and 38 (severe).

Group	Value	95% CI
REGN1908-1909	16.184	± 0.9370
Placebo	15.290	± 0.9173

Daily TNSS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo Secondary · Weeks 0 to 12

The TNSS ranges from 0 to 12 and is based on assessment of 4 nasal symptoms graded on a Likert scale ranging from 0 (none) to 3 (severe) for nasal congestion, itching, and runny nose, and sneezing.

Group	Value	95% CI
REGN1908-1909	6.18	± 0.320
Placebo	5.88	± 0.314

Percent Change From Pre-treatment Baseline in Average CSMS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo Secondary · Weeks 0 to 12

The combined symptom and medication score (CSMS) is defined as the daily combined allergic rhinitis and conjunctivitis total symptom score (TSS: calculated as the sum of total nasal symptom score \[TNSS\] and total ocular symptom score \[TOSS\]) plus daily medication score (DMS).

Group	Value	95% CI
REGN1908-1909	-29.25	± 4.363
Placebo	-33.16	± 28.299

Percent Change From Pre-treatment Baseline in Average TNSS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo Secondary · Weeks 0 to 12

The TNSS ranges from 0 to 12 and is based on assessment of 4 nasal symptoms graded on a Likert scale ranging from 0 (none) to 3 (severe) for nasal congestion, itching, and runny nose, and sneezing.

Group	Value	95% CI
REGN1908-1909	-26.77	± 29.471
Placebo	-30.33	± 27.976

Percent Change From Pre-treatment Baseline in Average TSS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo Secondary · Weeks 0 to 12

Total symptom score (TSS: calculated as the sum of TNSS and total ocular symptom score \[TOSS\]) plus daily medication score (DMS).

Group	Value	95% CI
REGN1908-1909	-27.25	± 30.185
Placebo	-31.16	± 28.390

Daily TSS Score Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo Secondary · Weeks 0 to 12

Total symptom score (TSS: calculated as the sum of TNSS and total ocular symptom score \[TOSS\]) plus daily medication score (DMS).

Group	Value	95% CI
REGN1908-1909	8.11	± 3.743
Placebo	7.80	± 3.507

Percent Change From Pre-treatment Baseline in Average TOSS, Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo Secondary · Weeks 0 to 12

Total ocular symptom score is 0 to 6 and is based on itching/redness/gritty feeling and tearing/watering; each of the 2 symptoms is graded 0 (absent), 1 (mild), 2 (moderate), and 3 (severe)

Group	Value	95% CI
REGN1908-1909	-27.90	± 38.216
Placebo	-32.92	± 35.708

Percent Change in Forced Expiratory Volume (FEV)1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo Secondary · Baseline to week 12

In-clinic spirometry on all patients to determine FEV1 (forced expiratory volume in 1 second) in liters (L).

Group	Value	95% CI
REGN1908-1909	1.35	± 7.314
Placebo	-0.05	± 5.334

Daily Number of Nighttime Awakenings Averaged Over the Initial 12 Weeks of the Treatment Period in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo Secondary · Weeks 0 to 12

Group	Value	95% CI
REGN1908-1909	0.54	± 0.846
Placebo	0.72	± 1.166

Number of Participants With Adverse Event of Special Interests (AESIs) Throughout the Study Secondary · Weeks 0 to 72

Group	Value	95% CI
Placebo	0
REGN1908-1909	2

Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) Throughout the Study Secondary · Weeks 0 to 60

Group	Value	95% CI
Placebo	2
REGN1908-1909	2

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study Secondary · Weeks 0 to 72

Group	Value	95% CI
Placebo	2
REGN1908-1909	2

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose to study termination (~60 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 2/222 (1%)

Deaths: 0/222

R1908-1909 600 mg

Serious: 2/218 (1%)

Deaths: 0/218

Serious adverse events (4 terms)

Reaction	System	Placebo	R1908-1909 600 mg
Meniere's disease	Ear and labyrinth disorders	—	—
Gastrointestinal procedural complication	Injury, poisoning and procedural complications	—	—
COVID-19	Infections and infestations	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Placebo	R1908-1909 600 mg
COVID-19	Infections and infestations	—	—
Nasopharyngitis	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—

Most-reported serious reactions: Meniere's disease, Gastrointestinal procedural complication, COVID-19, Asthma.

Data from ClinicalTrials.gov NCT04981717 adverse events section.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Allergy: Mechanistic insights into new methods of prevention and therapy.
   Akdis CA, Akdis M, Boyd SD, Sampath V, et al · · 2023 · cited 52× · PMID 36652536 · DOI 10.1126/scitranslmed.add2563
2. Biologics as novel therapeutics for the treatment of allergy: Challenges and opportunities.
   Atanasio A, Orengo JM, Sleeman MA, Stahl N. · · 2022 · cited 11× · PMID 36353195 · DOI 10.3389/falgy.2022.1019255
3. Single-Domain Antibodies-Novel Tools to Study and Treat Allergies.
   Zettl I, Bauernfeind C, Kollárová J, Flicker S. · · 2024 · cited 2× · PMID 39062843 · DOI 10.3390/ijms25147602
4. Chinese Position Paper on Biologic Therapy for Allergic Rhinitis.
   Zhang Y, Li J, Li X, Wang M, et al · · 2026 · cited 1× · PMID 41872701 · DOI 10.1111/all.70312