Allergic RhinitisPhase 2NCT03558997
Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy
A Phase 2 study testing Dupilumab and Timothy Grass SCIT in people with Allergic Rhinitis, run by Regeneron Pharmaceuticals at 17 sites in 2 countries.
Trial summary
The primary objective is to assess whether 16 weeks of treatment with dupilumab as an adjunct to Timothy Grass Subcutaneous Immunotherapy (SCIT) improves upon the efficacy of Timothy Grass SCIT to reduce provoked allergic rhinitis symptoms, as measured by Total Nasal Symptom Score (TNSS) after nasal allergen challenge… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Dupilumab and Timothy Grass SCIT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 7 Jun 2018to 13 Jun 2019
- Phase
- Phase 2
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female participants aged 18 to 55
- History of grass pollen-induced seasonal allergic rhinitis
- Grass pollen allergy confirmed by both:
- Positive skin prick test (SPT) with Timothy Grass extract (mean wheal diameter at least ≥5 mm greater than a negative control)
- Positive serum Timothy Grass-specific IgE (≥0.35KU/L)
Who cannot join
- Significant rhinitis, sinusitis, outside of the grass pollen season
- Any contraindications to SCIT (i.e, severe cardiovascular disease, malignancies, autoimmune disease, use of beta blocker, asthma severe enough to require chronic medication, acute infection)
- Use of systemic corticosteroids within 4 weeks of screening visits or any NAC visits
- Abnormal lung function as judged by the investigator
- A clinical history of asthma requiring chronic medication such as regular inhaled corticosteroids for >4 weeks per year
- History of significant recurrent sinusitis, defined as 3 episodes per year for the last 2 years, all of which required antibiotic treatment
Show all 9Show fewer
- History of chronic sinusitis (with or without nasal polyps)
- Tobacco smoking (ANY) within the last year
- Note: Other protocol defined inclusion/ exclusion criteria apply
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States12 sites
Regeneron Investigational Site
Andover, Massachusetts, 01810
Regeneron Investigational Site
Baltimore, Maryland, 21224
Regeneron Investigational Site
Bellevue, Nebraska, 68123
Regeneron Investigational Site
East Providence, Rhode Island, 02914
Regeneron Investigational Site
Los Angeles, California, 90025
Regeneron Investigational Site
Madison, Wisconsin, 53792-9988
Regeneron Investigational Site
Mountain View, California, 94040
Regeneron Investigational Site
North Dartmouth, Massachusetts, 02747
Regeneron Investigational Site
Portland, Oregon, 97202
Regeneron Investigational Site
Seattle, Washington, 98115
Regeneron Investigational Site
St Louis, Missouri, 63141
Regeneron Investigational Site
Walnut Creek, California, 94598
Canada5 sites
Regeneron Investigational Site
Kingston, Ontario, K7L 2V7
Regeneron Investigational Site
Mississauga, Ontario, L5A 3V4
Regeneron Investigational Site
Ottawa, Ontario, K1G 6C6
Regeneron Investigational Site
Québec, Quebec, G1V 4W2
Regeneron Investigational Site
Toronto, Ontario, M4V 1R2
About this study
Official title: A Study To Evaluate The Efficacy Of Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy To Reduce Provoked Allergic Rhinitis Symptoms Using The Nasal Allergen Challenge Model
The primary objective is to assess whether 16 weeks of treatment with dupilumab as an adjunct to Timothy Grass Subcutaneous Immunotherapy (SCIT) improves upon the efficacy of Timothy Grass SCIT to reduce provoked allergic rhinitis symptoms, as measured by Total Nasal Symptom Score (TNSS) after nasal allergen challenge (NAC) with Timothy Grass extract at week 17.
The secondary objectives of the study are:
- To assess whether 16 weeks of treatment with dupilumab as compared to placebo reduces provoked allergic rhinitis symptoms, as measured by TNSS after nasal allergen challenge (NAC) with Timothy Grass extract
- To assess whether 16 weeks of treatment with dupilumab as compared to dupilumab + SCIT reduces provoked allergic rhinitis symptoms, as measured by TNSS after nasal allergen challenge (NAC) with Timothy Grass extract
- To assess changes in serum Timothy-grass-specific immunoglobulin G4 (IgG4), serum Timothy grass-specific immunoglobulin E (IgE), and ratio of serum Timothy Grass-specific IgG4 to IgE over 16 weeks of treatment with dupilumab + SCIT as compared to SCIT monotherapy
- To evaluate the safety and tolerability of 16 weeks of treatment with dupilumab as an adjunct to Timothy Grass SCIT
- Conditions
- Allergic Rhinitis
- Being tested
- Dupilumab, Timothy Grass SCIT, Placebo matching dupilumab, Placebo matching SCIT
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called DUPIXENT®, REGN668, SAR231893
Dupilumab was administered SC in a single-use, pre-filled glass syringe
Timothy Grass SCITDrug
Timothy grass extract was administered SC.
Placebo matching dupilumabDrug
Placebo matching dupilumab was prepared in the same formulation without the addition of protein
Placebo matching SCITDrug
Placebo matching SCIT was prepared in the same formulation (SCIT diluent) without the addition of Timothy grass extract
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Participants received placebo matched to Dupilumab and placebo matched to Timothy grass subcutaneous immunotherapy (SCIT) every 2 weeks (Q2W) for 16 weeks. Both placebo doses were administered with a gap of 1 or 7 days. Receives: Drug: Placebo matching dupilumab; Drug: Placebo matching SCIT |
| Dupilumab | Experimental | Participants received placebo matched to SCIT and subcutaneous (SC) injections of Dupilumab at a loading dose of 600 milligrams (mg) on Day 1, followed by a 300 mg for Q2W for 16 weeks. Both placebo matched to SCIT and Dupilumab doses were administered with a gap of 1 or 7 days. Receives: Drug: Dupilumab; Drug: Placebo matching SCIT |
| SCIT | Experimental | Participants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 or 7 days. Receives: Drug: Timothy Grass SCIT; Drug: Placebo matching dupilumab |
| Dupilumab + SCIT | Experimental | Participants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 or 7 days. Receives: Drug: Dupilumab; Drug: Timothy Grass SCIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Total Nasal Symptom Score (TNSS) Area Under Curve (AUC) (0-1 Hour (hr) Post Peak TNSS) in Response to Post Nasal Allergen Challenge (NAC) at Week 17
TNSS was participant-reported composite symptom assessment of 4 symptoms (rhinorrhea, nasal congestion, nasal itching \& sneezing), each scored on a scale from 0 to 3 where 0 = none, 3 = severe. TNSS total score was calculated as the sum of the response for all 4 individual nasal symptom scores and ranged from 0 to 12, where higher score indicated more severe symptoms. AUC of TNSS/component from time of the first observation to time of the last observation (AUC [0-1 hr]) was calculated by using the trapezoid rule. Data was reported for Dupilumab + SCIT and placebo matched to Dupilumab + SCIT monotherapy group in this outcome measure.
Measured: Baseline, Week 17
Secondary outcomes (11)
Change From Baseline in Total Nasal Symptom Score (TNSS) Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour After the Challenge (0-1 Hour (hr) Post Peak TNSS) at Week 17 in SCIT vs. Dupilumab + SCIT
TNSS was participant-reported composite symptom assessment of 4 symptoms (rhinorrhea, nasal congestion, nasal itching \& sneezing) each scored on a scale from 0 to 3 where 0 = none, 3 = severe. TNSS total score was calculated as the sum of the response for all 4 individual nasal symptom scores and ranged from 0 to 12, where higher score indicated more severe symptoms. AUC of TNSS/component from time of the first observation to time of the last observation (AUC [0-1 hr]) was calculated by using the trapezoid rule. Data was reported for Dupilumab + SCIT and placebo matched to Dupilumab + SCIT monotherapy group in this outcome measure.
Measured: Baseline, Week 17
Change From Baseline in Total Nasal Symptom Score (TNSS) Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour After the Challenge (0-1 Hour (hr) Post Peak TNSS) at Week 17 in Placebo vs. Dupilumab
TNSS was participant-reported composite symptom assessment of 4 symptoms (rhinorrhea, nasal congestion, nasal itching \& sneezing) each scored on a scale from 0 to 3 where 0 = none, 3 = severe. TNSS total score was calculated as the sum of the response for all 4 individual nasal symptom scores and ranged from 0 to 12, where higher score indicated more severe symptoms. AUC of TNSS/component from time of the first observation to time of the last observation (AUC [0-1 hr]) was calculated by using the trapezoid rule. Data was reported for Dupilumab + placebo matched to SCIT and placebo matched to dupilumab + placebo matched to SCIT group in this outcome measure.
Measured: Baseline, Week 17
Percent Change From Baseline in Total Nasal Symptom Score (TNSS) Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour of the Challenge (0-1 Hour (hr) Post Peak TNSS) at Week 17
TNSS was participant-reported composite symptom assessment of 4 symptoms (rhinorrhea, nasal congestion, nasal itching \& sneezing) each scored on a scale from 0 to 3 where 0 = none, 3 = severe. TNSS total score was calculated as the sum of the response for all 4 individual nasal symptom scores and ranged from 0 to 12, where higher score indicated more severe symptoms. AUC of TNSS/component from time of the first observation to time of the last observation (AUC [0-1 hr]) was calculated by using the trapezoid rule. Data was reported for Dupilumab + placebo matched to SCIT and placebo matched to dupilumab + placebo matched to SCIT.
Measured: Baseline, Week 17
Change From Baseline in TNSS Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour of the Challenge (0-1 Hour (hr) Post Peak TNSS) at Week 17
TNSS was participant-reported composite symptom assessment of 4 symptoms (rhinorrhea, nasal congestion, nasal itching \& sneezing) each scored on a scale from 0 to 3 where 0 = none, 3 = severe. TNSS total score was calculated as the sum of responses for all 4 individual nasal symptom scores and ranged from 0 to 12, where higher score indicated more severe symptoms. AUC of TNSS/component from time of the first observation to time of the last observation (AUC [0-1 hr]) was calculated by using the trapezoid rule. Data was reported for Dupilumab + SCIT and Dupilumab + placebo matched to SCIT group in this outcome measure.
Measured: Baseline, Week 17
Percent Change From Baseline in TNSS Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour of the Challenge (0-1 Hour (hr) Post Peak TNSS) at Week 17
TNSS was participant-reported composite symptom assessment of 4 symptoms (rhinorrhea, nasal congestion, nasal itching \& sneezing) each scored on a scale from 0 to 3 where 0 = none, 3 = severe. TNSS total score was calculated as the sum of the response for all 4 individual nasal symptom scores and ranged from 0 to 12, where higher score indicated more severe symptoms. AUC of TNSS/component from time of the first observation to time of the last observation (AUC [0-1 hr]) was calculated by using the trapezoid rule. Data was reported for Dupilumab + SCIT and Dupilumab + placebo matched to SCIT group in this outcome measure.
Measured: Baseline, Week 17
Change From Baseline in Serum Timothy Grass Specific Immunoglobulin G4 (sIgG4) to Week 17
Measurement of Timothy Grass specific IgG4 was performed in serum or plasma to determine effects on biomarkers of relevant physiological and pathogenic processes. Data was reported for Dupilumab + SCIT and placebo matched to Dupilumab + SCIT monotherapy group in this outcome measure. Missing values were imputed by Last Observation Carried Forward (LOCF) method for visits between post-baseline to Week 17.
Measured: Baseline, Week 17
Percent Change From Baseline in Serum Timothy Grass Specific Immunoglobulin G4 (sIgG4) to Week 17
Measurement of Timothy Grass specific IgG4 was performed in serum or plasma to determine effects on biomarkers of relevant physiological and pathogenic processes. Data was for Dupilumab + SCIT and placebo matched to Dupilumab + SCIT monotherapy group in this outcome measure. Missing value was imputed by LOCF method for visits between post-baseline to Week 17.
Measured: Baseline, Week 17
Change From Baseline in Serum Timothy Grass Specific Immunoglobulin E (sIgE) to Week 17
Measurement of Timothy Grass specific sIgE was performed in serum or plasma to determine effects on biomarkers of relevant physiological and pathogenic processes. Data was reported for Dupilumab + SCIT and placebo matched to Dupilumab + SCIT monotherapy group in this outcome measure. Missing value was imputed by LOCF method for visits between post-baseline to Week 17.
Measured: Baseline, Week 17
Percent Change From Baseline in Serum Timothy Grass Specific Immunoglobulin E (sIgE) to Week 17
Measurement of Timothy Grass specific sIgE was performed in serum or plasma to determine effects on biomarkers of relevant physiological and pathogenic processes. Data was reported for Dupilumab + SCIT and placebo matched to Dupilumab + SCIT monotherapy group in this outcome measure. Missing value was imputed by LOCF method for visits between post-baseline to Week 17.
Measured: Baseline, Week 17
Change From Baseline in Log-Transformed Value of Serum Timothy Grass Specific Immunoglobulin G4 (sIgG4) to Serum Timothy Grass Specific Immunoglobulin E (sIgE) Ratio to Week 17
Biomarkers measured in serum or plasma to determine effects on biomarkers of relevant physiological and pathogenic processes. Data was reported for Dupilumab + SCIT and placebo matched to Dupilumab + SCIT monotherapy group in this outcome measure. Missing value was imputed by LOCF method for visits between post-baseline to Week 17.
Measured: Baseline, Week 17
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 24]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-participant hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Measured: Baseline through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start7 Jun 2018
- Primary completion14 May 2019
- Study completion13 Jun 2019
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.
- Publications (3)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558997
- Sponsor's protocol ID
- R668-ALG-16115
- Status last verified
- May 2020
- First submitted
- 5 Jun 2018
- Last updated
- 28 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wipperman MF, Gayvert KM, Atanasio A, Wang CQ, Corren J, Covarrubias A, Setliff I, Chio E, Laws E, Wolfe K, Harel S, Maloney J, Herman G, Orengo JM, Lim WK, Hamon SC, Hamilton JD, O'Brien MP. Differential modulation of allergic rhinitis nasal transcriptome by dupilumab and allergy immunotherapy. Allergy. 2024 Apr;79(4):894-907. doi: 10.1111/all.16001. Epub 2024 Jan 27.
PubMed 38279910Kamal MA, Franchetti Y, Lai CH, Xu C, Wang CQ, Radin AR, O'Brien MP, Ruddy M, Davis JD. Pharmacokinetics and Concentration-Response of Dupilumab in Patients With Seasonal Allergic Rhinitis. J Clin Pharmacol. 2022 May;62(5):689-695. doi: 10.1002/jcph.2004. Epub 2022 Jan 6.
PubMed 34791679Corren J, Saini SS, Gagnon R, Moss MH, Sussman G, Jacobs J, Laws E, Chung ES, Constant T, Sun Y, Maloney J, Hamilton JD, Ruddy M, Wang CQ, O'Brien MP. Short-Term Subcutaneous Allergy Immunotherapy and Dupilumab are Well Tolerated in Allergic Rhinitis: A Randomized Trial. J Asthma Allergy. 2021 Aug 16;14:1045-1063. doi: 10.2147/JAA.S318892. eCollection 2021.
PubMed 34429614
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study To Evaluate The Efficacy Of Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy To Reduce Provoked Allergic Rhinitis Symptoms Using The Nasal Allergen Challenge Model
- ClinicalTrials.gov ID
- NCT03558997
- Acronym / sponsor ID
- R668-ALG-16115
- Conditions
- Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 28 May 2020
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 whether 16 weeks of treatment with dupilumab as an adjunct to Timothy Grass Subcutaneous Immunotherapy (SCIT) improves upon the efficacy of Timothy Grass SCIT to reduce provoked allergic rhinitis symptoms, as measured by Total Nasal Symptom Score (TNSS) after nasal allergen challenge (NAC) with Timothy Grass extract at week 17.
The secondary objectives of the study are:
- To assess whether 16 weeks of treatment with dupilumab as compared to placebo reduces provoked allergic rhinitis symptoms, as measured by TNSS after nasal allergen challenge (NAC) with Timothy Grass extract
- To assess whether 16 weeks of treatment with dupilumab as compared to dupilumab + SCIT reduces provoked allergic rhinitis symptoms, as measured by TNSS after nasal allergen challenge (NAC) with Timothy Grass extract
- To assess changes in serum Timothy-grass-specific immunoglobulin G4 (IgG4), serum Timothy grass-specific immunoglobulin E (IgE), and ratio of serum Timothy Grass-specific IgG4 to IgE over 16 weeks of treatment with dupilumab + SCIT as compared to SCIT monotherapy
- To evaluate the safety and tolerability of 16 weeks of treatment with dupilumab as an adjunct to Timothy Grass SCIT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: Placebo matching dupilumab, Drug: Placebo matching SCITParticipants received placebo matched to Dupilumab and placebo matched to Timothy grass subcutaneous immunotherapy (SCIT) every 2 weeks (Q2W) for 16 weeks. Both placebo doses were administered with a gap of 1 or 7 days. |
| Dupilumab | Experimental | Drug: Dupilumab, Drug: Placebo matching SCITParticipants received placebo matched to SCIT and subcutaneous (SC) injections of Dupilumab at a loading dose of 600 milligrams (mg) on Day 1, followed by a 300 mg for Q2W for 16 weeks. Both placebo matched to SCIT and Dupilumab doses were administered with a gap of 1 or 7 days. |
| SCIT | Experimental | Drug: Timothy Grass SCIT, Drug: Placebo matching dupilumabParticipants received SCIT titrated up to a 4000 bioequivalent allergy unit (BAU) for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks and SC injections of placebo matched to Dupilumab Q2W for 16 weeks. Both SCIT and placebo matched to Dupilumab doses were administered with a gap of 1 or 7 days. |
| Dupilumab + SCIT | Experimental | Drug: Dupilumab, Drug: Timothy Grass SCITParticipants received SC injections of Dupilumab at a loading dose of 600 mg on Day 1, followed by 300 mg Q2W for 16 weeks and SCIT titrated up to 4000 BAU for 8 weeks followed by maintenance dose of 4000 BAU for following 8 weeks. Both SCIT and Dupilumab doses were administered with a gap of 1 or 7 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female participants aged 18 to 55
- History of grass pollen-induced seasonal allergic rhinitis
- Grass pollen allergy confirmed by both:
Key exclusion criteria (9 listed)
- Significant rhinitis, sinusitis, outside of the grass pollen season
- Any contraindications to SCIT (i.e, severe cardiovascular disease, malignancies, autoimmune disease, use of beta blocker, asthma severe enough to require chronic medication, acute infection)
- Use of systemic corticosteroids within 4 weeks of screening visits or any NAC visits
- Abnormal lung function as judged by the investigator
- A clinical history of asthma requiring chronic medication such as regular inhaled corticosteroids for >4 weeks per year
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 |
|---|---|---|
| DupilumabAlso: DUPIXENT®, REGN668, SAR231893Dupilumab was administered SC in a single-use, pre-filled glass syringe | Drug | Dupilumab, Dupilumab + SCIT |
| Timothy Grass SCITTimothy grass extract was administered SC. | Drug | Dupilumab + SCIT, SCIT |
| Placebo matching dupilumabPlacebo matching dupilumab was prepared in the same formulation without the addition of protein | Drug | Placebo, SCIT |
| Placebo matching SCITPlacebo matching SCIT was prepared in the same formulation (SCIT diluent) without the addition of Timothy grass extract | Drug | Dupilumab, Placebo |
Primary outcome
Percent Change From Baseline in Total Nasal Symptom Score (TNSS) Area Under Curve (AUC) (0-1 Hour (hr) Post Peak TNSS) in Response to Post Nasal Allergen Challenge (NAC) at Week 17
Time frame: Baseline, Week 17
TNSS was participant-reported composite symptom assessment of 4 symptoms (rhinorrhea, nasal congestion, nasal itching \& sneezing), each scored on a scale from 0 to 3 where 0 = none, 3 = severe. TNSS total score was calculated as the sum of the response for all 4 individual nasal symptom scores and ranged from 0 to 12, where higher score indicated more severe symptoms. AUC of TNSS/component from time of the first observation to time of the last observation (AUC [0-1 hr]) was calculated by using the trapezoid rule. Data was reported for Dupilumab + SCIT and placebo matched to Dupilumab + SCIT monotherapy group in this outcome measure.
11 secondary outcomes
Change From Baseline in Total Nasal Symptom Score (TNSS) Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour After the Challenge (0-1 Hour (hr) Post Peak TNSS) at Week 17 in SCIT vs. Dupilumab + SCIT
Time frame: Baseline, Week 17
Change From Baseline in Total Nasal Symptom Score (TNSS) Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour After the Challenge (0-1 Hour (hr) Post Peak TNSS) at Week 17 in Placebo vs. Dupilumab
Time frame: Baseline, Week 17
Percent Change From Baseline in Total Nasal Symptom Score (TNSS) Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour of the Challenge (0-1 Hour (hr) Post Peak TNSS) at Week 17
Time frame: Baseline, Week 17
Change From Baseline in TNSS Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour of the Challenge (0-1 Hour (hr) Post Peak TNSS) at Week 17
Time frame: Baseline, Week 17
Percent Change From Baseline in TNSS Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour of the Challenge (0-1 Hour (hr) Post Peak TNSS) at Week 17
Time frame: Baseline, Week 17
Change From Baseline in Serum Timothy Grass Specific Immunoglobulin G4 (sIgG4) to Week 17
Time frame: Baseline, Week 17
Percent Change From Baseline in Serum Timothy Grass Specific Immunoglobulin G4 (sIgG4) to Week 17
Time frame: Baseline, Week 17
Change From Baseline in Serum Timothy Grass Specific Immunoglobulin E (sIgE) to Week 17
Time frame: Baseline, Week 17
Percent Change From Baseline in Serum Timothy Grass Specific Immunoglobulin E (sIgE) to Week 17
Time frame: Baseline, Week 17
Change From Baseline in Log-Transformed Value of Serum Timothy Grass Specific Immunoglobulin G4 (sIgG4) to Serum Timothy Grass Specific Immunoglobulin E (sIgE) Ratio to Week 17
Time frame: Baseline, Week 17
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: Baseline through Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38279910Wipperman MF, Gayvert KM, Atanasio A, Wang CQ, Corren J, Covarrubias A, Setliff I, Chio E, Laws E, Wolfe K, Harel S, Maloney J, Herman G, Orengo JM, Lim WK, Hamon SC, Hamilton JD, O'Brien MP. Differential modulation of allergic rhinitis nasal transcriptome by dupilumab and allergy immunotherapy. Allergy. 2024 Apr;79(4):894-907. doi: 10.1111/all.16001. Epub 2024 Jan 27.
- Derived from this study: PubMed 34791679Kamal MA, Franchetti Y, Lai CH, Xu C, Wang CQ, Radin AR, O'Brien MP, Ruddy M, Davis JD. Pharmacokinetics and Concentration-Response of Dupilumab in Patients With Seasonal Allergic Rhinitis. J Clin Pharmacol. 2022 May;62(5):689-695. doi: 10.1002/jcph.2004. Epub 2022 Jan 6.
- Derived from this study: PubMed 34429614Corren J, Saini SS, Gagnon R, Moss MH, Sussman G, Jacobs J, Laws E, Chung ES, Constant T, Sun Y, Maloney J, Hamilton JD, Ruddy M, Wang CQ, O'Brien MP. Short-Term Subcutaneous Allergy Immunotherapy and Dupilumab are Well Tolerated in Allergic Rhinitis: A Randomized Trial. J Asthma Allergy. 2021 Aug 16;14:1045-1063. doi: 10.2147/JAA.S318892. eCollection 2021.
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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
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab and Timothy Grass SCIT in people with Allergic Rhinitis, run by Regeneron Pharmaceuticals at 17 sites in 2 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 5 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 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 May 2020). 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?
Percent Change From Baseline in Total Nasal Symptom Score (TNSS) Area Under Curve (AUC) (0-1 Hour (hr) Post Peak TNSS) in Response to Post Nasal Allergen Challenge (NAC) at Week 17 (time frame: Baseline, Week 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03558997, which also lists 3 linked publications.
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 28 May 2020.