Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy
NCT ID: NCT03558997
Last Updated: 2020-05-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
103 participants
INTERVENTIONAL
2018-06-07
2019-06-13
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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SCIT
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.
Timothy Grass SCIT
Timothy grass extract was administered SC.
Placebo matching dupilumab
Placebo matching dupilumab was prepared in the same formulation without the addition of protein
Dupilumab + SCIT
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.
Dupilumab
Dupilumab was administered SC in a single-use, pre-filled glass syringe
Timothy Grass SCIT
Timothy grass extract was administered SC.
Placebo
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.
Placebo matching dupilumab
Placebo matching dupilumab was prepared in the same formulation without the addition of protein
Placebo matching SCIT
Placebo matching SCIT was prepared in the same formulation (SCIT diluent) without the addition of Timothy grass extract
Dupilumab
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.
Dupilumab
Dupilumab was administered SC in a single-use, pre-filled glass syringe
Placebo matching SCIT
Placebo matching SCIT was prepared in the same formulation (SCIT diluent) without the addition of Timothy grass extract
Interventions
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Dupilumab
Dupilumab was administered SC in a single-use, pre-filled glass syringe
Timothy Grass SCIT
Timothy grass extract was administered SC.
Placebo matching dupilumab
Placebo matching dupilumab was prepared in the same formulation without the addition of protein
Placebo matching SCIT
Placebo matching SCIT was prepared in the same formulation (SCIT diluent) without the addition of Timothy grass extract
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. History of grass pollen-induced seasonal allergic rhinitis
3. Grass pollen allergy confirmed by both:
1. Positive skin prick test (SPT) with Timothy Grass extract (mean wheal diameter at least ≥5 mm greater than a negative control)
2. Positive serum Timothy Grass-specific IgE (≥0.35KU/L)
Exclusion Criteria
2. 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)
3. Use of systemic corticosteroids within 4 weeks of screening visits or any NAC visits
4. Abnormal lung function as judged by the investigator
5. A clinical history of asthma requiring chronic medication such as regular inhaled corticosteroids for \>4 weeks per year
6. History of significant recurrent sinusitis, defined as 3 episodes per year for the last 2 years, all of which required antibiotic treatment
7. History of chronic sinusitis (with or without nasal polyps)
8. Tobacco smoking (ANY) within the last year
18 Years
55 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Regeneron Investigational Site
Los Angeles, California, United States
Regeneron Investigational Site
Mountain View, California, United States
Regeneron Investigational Site
Walnut Creek, California, United States
Regeneron Investigational Site
Baltimore, Maryland, United States
Regeneron Investigational Site
Andover, Massachusetts, United States
Regeneron Investigational Site
North Dartmouth, Massachusetts, United States
Regeneron Investigational Site
St Louis, Missouri, United States
Regeneron Investigational Site
Bellevue, Nebraska, United States
Regeneron Investigational Site
Portland, Oregon, United States
Regeneron Investigational Site
East Providence, Rhode Island, United States
Regeneron Investigational Site
Seattle, Washington, United States
Regeneron Investigational Site
Madison, Wisconsin, United States
Regeneron Investigational Site
Kingston, Ontario, Canada
Regeneron Investigational Site
Mississauga, Ontario, Canada
Regeneron Investigational Site
Ottawa, Ontario, Canada
Regeneron Investigational Site
Toronto, Ontario, Canada
Regeneron Investigational Site
Québec, Quebec, Canada
Countries
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References
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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.
Kamal 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.
Corren 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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R668-ALG-16115
Identifier Type: -
Identifier Source: org_study_id
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