Allergic RhinitisPhase 3NCT04709575
Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis
A Phase 3 study testing REGN5713, REGN5714 and REGN5715 in people with Allergic Rhinitis and Conjunctivitis, run by Regeneron Pharmaceuticals at 37 sites in 5 countries.
Trial summary
The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch pollen season after a single dose of REGN5713-5714-5715 versus placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis, Conjunctivitis
- What is being tested?
- REGN5713, REGN5714 and REGN5715
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 353 participants
- Where
- 37 sitesin 5 countries
- Study dates
- 14 Jan 2021to 24 Aug 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented or participant-reported history of birch pollen-triggered allergic rhinitis symptoms, with or without conjunctivitis, for at least 2 years
- Positive Skin prick test (SPT) with birch pollen extract in the screening period, as defined in the protocol
- Positive Allergen-specific IgE (sIgE) tests for birch pollen and Bet v 1 in the screening period, as defined in the protocol
- Willing and able to comply with clinic visits and study-related procedures
Who cannot join
- Participation in a prior REGN5713-5714-5715 clinical trial
- Recurrent or chronic rhinitis or sinusitis not associated with birch pollen season, or due to daily contact with other allergens causing symptoms that are expected to coincide with birch pollen season, as assessed by the investigator
- Participants who anticipate major changes in allergen exposure in their home or work environments that are expected to coincide with the study assessments as assessed by the investigator
- Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections (at the discretion of the investigator) within 4 weeks prior to screening visit. Participants may be re-evaluated for eligibility after symptoms resolve
- Documentation of active SARS-CoV-2 infection, as defined in the protocol
- A clinical history of asthma with 2 or more asthma exacerbations requiring hospitalizations or systemic corticosteroids in the previous year
Show all 9Show fewer
- History of birch allergy immunotherapy as defined in the protocol
- Use of anti-IgE or other biological therapy in treatment of asthma or allergy within 6 months prior to screening
- NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
Trial locations and contacts
37 sites in 5 countries.
37 sites in 5 countries
United States14 sites
Regeneron Study Site
Baltimore, Maryland, 21224
Regeneron Study Site
Bangor, Maine, 04401
Regeneron Study Site
Cincinnati, Ohio, 45231
Regeneron Study Site
Columbia, Missouri, 65212
Regeneron Study Site
Great Neck, New York, 11021
Regeneron Study Site
Greenfield, Wisconsin, 53228
Regeneron Study Site
Lincoln, Rhode Island, 02865
Regeneron Study Site
Missoula, Montana, 59808
Regeneron Study Site
Pittsburgh, Pennsylvania, 15241
Regeneron Study Site
Plymouth, Minnesota, 55441
Regeneron Study Site
Portland, Oregon, 97202
Regeneron Study Site
St Louis, Missouri, 63141
Regeneron Study Site
Toledo, Ohio, 43617
Regeneron Study Site
Verona, New Jersey, 07044
Germany10 sites
Regeneron Study Site
Berlin, 10117
Regeneron Study Site
Berlin, 14050
Regeneron Study Site
Dreieich, Hesse, 63303
Regeneron Study Site
Dresden, Saxony, 01139
Regeneron Study Site
Duisburg, North Rhine-Westphalia, 47051
Regeneron Study Site
Düsseldorf, North Rhine-Westphalia, 40225
Regeneron Study Site
Hamburg, 22549
Regeneron Study Site
Heidelberg, Baden-Wurttemberg, 69120
Regeneron Study Site
Stuttgart, Baden-Wurttemberg, 70374
Regeneron Study Site
Wiesbaden, Hesse, 65183
Canada8 sites
Regeneron Study Site
Kingston, Ontario, K7L 2V7
Regeneron Study Site
London, Ontario, N5W 6A2
Regeneron Study Site
Ottawa, Ontario, K1G 6C6
Regeneron Study Site
Québec, G1V 4M6
Regeneron Study Site
Toronto, Ontario, M4V 1R2
Regeneron Study Site
Toronto, Ontario, M5B 1W8
Regeneron Study Site
Toronto, Ontario, M5G 1E2
Regeneron Study Site
Trois-Rivières, Quebec, G8T 7A1
Denmark3 sites
Regeneron Study Site
Hellerup, Copenhagen Surroundings, 2900
Regeneron Study Site
Hvidovre, Capital, 2650
Regeneron Study Site
Vejle, South Jutland, 7100
Belgium2 sites
Regeneron Study Site
Ghent, Oost-Vlaanderen, 9000
Regeneron Study Site
Leuven, Vlaams Brabant, 3000
About this study
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Anti-Bet v 1 Monoclonal Antibodies to Reduce Symptoms of Seasonal Allergic Rhinitis
The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch pollen season after a single dose of REGN5713-5714-5715 versus placebo.
- Conditions
- Allergic Rhinitis, Conjunctivitis
- Being tested
- REGN5713, REGN5714, REGN5715, Placebo
- Keywords
- Birch Allergy
- Medical subject headings
- Rhinitis, Allergic, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN5713Drug
Administered subcutaneously
REGN5714Drug
Administered subcutaneously
REGN5715Drug
Administered subcutaneously
PlaceboDrug
Placebo that replaces REGN5713-5714-5715
| Study group | Role | What they receive |
|---|---|---|
| REGN5713-5714-5715 | Experimental | REGN5713-5714-5715 administered subcutaneously Receives: Drug: REGN5713; Drug: REGN5714; Drug: REGN5715 |
| Placebo Only | Placebo comparator | Placebo matching REGN5713-5714-5715 administered subcutaneously Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Symptom and Medication Score (CSMS) in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
The average CSMS will be calculated based on daily symptom score and daily medication score recorded over the duration of the birch pollen season (BPS). CSMS is calculated by adding the Daily Medication Score (DMS) and Total Symptom Score (TSS) together, with scores ranging between 0 (none) and 38 (severe).
Measured: Until the end of Birch Pollen Season, up to Week 16
Secondary outcomes (15)
Total Symptom Score (TSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
TSS is a combined score of TOSS and TNSS. TNSS and TOSS are scored as in part 1 each for a combined TSS of 0 (none) to 18 (severe)
Measured: Until the end of Birch Pollen Season, up to Week 16
Total Nasal Symptom Score (TNSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
Total nasal symptom score (TNSS) is 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 congestion, itching, and rhinorrhea, and from 0 (none) to 3 (5 or more sneezes) for sneezing.
Measured: Until the end of Birch Pollen Season, up to Week 16
Total Ocular Symptom Score (TOSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
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)
Measured: Until the end of Birch Pollen Season, up to Week 16
Daily Medication Score (DMS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
The Daily Medication Score (DMS) is calculated by adding points for each pre-specified medication taken as follows: desloratadine 5 mg 6 points/dose; maximum daily score 6 points, olopatadine 1 mg/mL each drop 1.5 points/drop; maximum daily score 6 points, mometasone furoate 50 ug/dose 2.0 points/spray; maximum daily score 8 points). The scale is 0 (minimum) to 20 (maximum)
Measured: Until the end of Birch Pollen Season, up to Week 16
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Throughout the Study
Number of participants with any Treatment Emergent Adverse Events (TEAEs) from participating in study
Measured: Up to Day 127
Number of Participants With Serious TEAEs Throughout the Study
Number of participants with any Serious Treatment Emergent Adverse Events (TEAEs) from participating in study
Measured: Up to Day 127
Change From Baseline to the End of Study in Birch SPT Mean Wheal Diameter in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
Number of participants who showed change from baseline to the end of the study in Birch Skin Prick Test (SPT) Mean Wheal Diameter, in participants who received REGN5713-5714-5715 compared to placebo
Measured: Baseline through Day 127
Percent Change From Baseline to the End of Study in Birch SPT Mean Wheal Diameter in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
Measured: Baseline through Day 127
Serum Concentration of REGN5713 Over the Study Duration
Measured: Day 0, Day 56, Day 112
Serum Concentration of REGN5714 Over the Study Duration
Measured: Up to Day 127
Serum Concentration of REGN5715 Over the Study Duration
Measured: Up to Day 127
Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5713 Throughout the Study
Percentage of participants who developed antibodies to intervention provided during study
Measured: Up to Day 127
Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5714 Throughout the Study
Percentage of participants who developed antibodies to intervention provided during study
Measured: Up to Day 127
Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5715 Throughout the Study
Percentage of participants who developed antibodies to intervention provided during study
Measured: Up to Day 127
Number of "Well Days"
"Well Days" are defined as days when rescue medication is not utilized and the Total symptom score (TSS) is ≤2/18
Measured: Until the end of Birch Pollen Season, up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start14 Jan 2021
- Primary completion24 Aug 2021
- Study completion24 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709575
- Sponsor's protocol ID
- R5713-5714-5715-ALG-2001
- Other IDs
- 2020-004094-52
- Status last verified
- Sep 2022
- First submitted
- 23 Dec 2020
- Last updated
- 27 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Anti-Bet v 1 Monoclonal Antibodies to Reduce Symptoms of Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT04709575
- Acronym / sponsor ID
- R5713-5714-5715-ALG-2001
- Conditions
- Allergic Rhinitis, Conjunctivitis
- Keywords
- Birch Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Posted 27 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch pollen season after a single dose of REGN5713-5714-5715 versus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REGN5713-5714-5715 | Experimental | Drug: REGN5713, Drug: REGN5714, Drug: REGN5715REGN5713-5714-5715 administered subcutaneously |
| Placebo Only | Placebo comparator | Drug: PlaceboPlacebo matching REGN5713-5714-5715 administered subcutaneously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented or participant-reported history of birch pollen-triggered allergic rhinitis symptoms, with or without conjunctivitis, for at least 2 years
- Positive Skin prick test (SPT) with birch pollen extract in the screening period, as defined in the protocol
- Positive Allergen-specific IgE (sIgE) tests for birch pollen and Bet v 1 in the screening period, as defined in the protocol
- Willing and able to comply with clinic visits and study-related procedures
Key exclusion criteria (9 listed)
- Participation in a prior REGN5713-5714-5715 clinical trial
- Recurrent or chronic rhinitis or sinusitis not associated with birch pollen season, or due to daily contact with other allergens causing symptoms that are expected to coincide with birch pollen season, as assessed by the investigator
- Participants who anticipate major changes in allergen exposure in their home or work environments that are expected to coincide with the study assessments as assessed by the investigator
- Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections (at the discretion of the investigator) within 4 weeks prior to screening visit. Participants may be re-evaluated for eligibility after symptoms resolve
- Documentation of active SARS-CoV-2 infection, as defined in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN5713Administered subcutaneously | Drug | REGN5713-5714-5715 |
| REGN5714Administered subcutaneously | Drug | REGN5713-5714-5715 |
| REGN5715Administered subcutaneously | Drug | REGN5713-5714-5715 |
| PlaceboPlacebo that replaces REGN5713-5714-5715 | Drug | Placebo Only |
Primary outcome
Combined Symptom and Medication Score (CSMS) in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
Time frame: Until the end of Birch Pollen Season, up to Week 16
The average CSMS will be calculated based on daily symptom score and daily medication score recorded over the duration of the birch pollen season (BPS). CSMS is calculated by adding the Daily Medication Score (DMS) and Total Symptom Score (TSS) together, with scores ranging between 0 (none) and 38 (severe).
15 secondary outcomes
Total Symptom Score (TSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
Time frame: Until the end of Birch Pollen Season, up to Week 16
Total Nasal Symptom Score (TNSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
Time frame: Until the end of Birch Pollen Season, up to Week 16
Total Ocular Symptom Score (TOSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
Time frame: Until the end of Birch Pollen Season, up to Week 16
Daily Medication Score (DMS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
Time frame: Until the end of Birch Pollen Season, up to Week 16
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Throughout the Study
Time frame: Up to Day 127
Number of Participants With Serious TEAEs Throughout the Study
Time frame: Up to Day 127
Change From Baseline to the End of Study in Birch SPT Mean Wheal Diameter in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
Time frame: Baseline through Day 127
Percent Change From Baseline to the End of Study in Birch SPT Mean Wheal Diameter in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
Time frame: Baseline through Day 127
Serum Concentration of REGN5713 Over the Study Duration
Time frame: Day 0, Day 56, Day 112
Serum Concentration of REGN5714 Over the Study Duration
Time frame: Up to Day 127
Serum Concentration of REGN5715 Over the Study Duration
Time frame: Up to Day 127
Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5713 Throughout the Study
Time frame: Up to Day 127
Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5714 Throughout the Study
Time frame: Up to Day 127
Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5715 Throughout the Study
Time frame: Up to Day 127
Number of "Well Days"
Time frame: Until the end of Birch Pollen Season, up to Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
37 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing REGN5713, REGN5714 and REGN5715 in people with Allergic Rhinitis and Conjunctivitis, run by Regeneron Pharmaceuticals at 37 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Germany, Canada, Denmark, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Symptom and Medication Score (CSMS) in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo (time frame: Until the end of Birch Pollen Season, up to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.