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Trial record 1 of 1 for:    NCT03558997
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Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy

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ClinicalTrials.gov Identifier: NCT03558997
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief 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 (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 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

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: Dupilumab Drug: Timothy Grass SCIT Drug: Placebo matching dupilumab Drug: Placebo matching SCIT Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 7, 2018
Estimated Primary Completion Date : March 25, 2019
Estimated Study Completion Date : May 24, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: Dupilumab + Timothy Grass SCIT Drug: Dupilumab
Dupilumab will be administered subcutaneously (SC) in a single-use, pre-filled glass syringe
Other Names:
  • DUPIXENT®
  • REGN668
  • SAR231893

Drug: Timothy Grass SCIT
Timothy Grass extract will be administered subcutaneously (SC)

Experimental: Placebo matching dupilumab + Timothy Grass SCIT Drug: Timothy Grass SCIT
Timothy Grass extract will be administered subcutaneously (SC)

Drug: Placebo matching dupilumab
Placebo matching dupilumab is prepared in the same formulation without the addition of protein

Experimental: Dupilumab + Placebo matching SCIT Drug: Placebo matching dupilumab
Placebo matching dupilumab is prepared in the same formulation without the addition of protein

Drug: Placebo matching SCIT
Placebo matching SCIT is prepared in the same formulation (SCIT diluent) without the addition of Timothy Grass extract

Experimental: Placebo matching dupilumab + Placebo matching SCIT Drug: Placebo matching dupilumab
Placebo matching dupilumab is prepared in the same formulation without the addition of protein

Drug: Placebo matching SCIT
Placebo matching SCIT is prepared in the same formulation (SCIT diluent) without the addition of Timothy Grass extract




Primary Outcome Measures :
  1. Percent change in the area under the curve (AUC) for TNSS (0-1 hr post peak TNSS) in response to a NAC at week 17 from the pretreatment baseline TNSS AUC (0-1 hr post peak TNSS) for dupilumab + SCIT as compared to placebo + SCIT monotherapy [ Time Frame: At week 17 ]

Secondary Outcome Measures :
  1. Change from baseline in TNSS AUC post NAC over the first hour after the challenge (0-1 hr post peak TNSS) at week 17 for dupilumab + SCIT as compared to SCIT monotherapy [ Time Frame: At week 17 ]
  2. Change from baseline in TNSS AUC post NAC over the first hour of the challenge (0-1 hr post peak TNSS) at week 17 for dupilumab monotherapy as compared to placebo [ Time Frame: At week 17 ]
  3. Percent change from baseline in TNSS AUC post NAC over the first hour of the challenge (0-1 hr post peak TNSS) at week 17 for dupilumab monotherapy as compared to placebo [ Time Frame: At week 17 ]
  4. Change from baseline (last pretreatment measurement) to week 17 in serum Timothy Grass (specific immunoglobulin G4) sIgG4 for dupilumab + SCIT as compared to SCIT monotherapy [ Time Frame: Baseline to week 17 ]
  5. Percent change from baseline (last pretreatment measurement) to week 17 in serum Timothy Grass sIgG4 for dupilumab + SCIT as compared to SCIT monotherapy [ Time Frame: Baseline to week 17 ]
  6. Change from baseline (last pretreatment measurement) to week 17 in serum Timothy Grass sIgE for dupilumab + SCIT as compared to SCIT monotherapy [ Time Frame: Baseline to week 17 ]
  7. Percent change from baseline (last pretreatment measurement) to week 17 in serum Timothy Grass sIgE for dupilumab + SCIT as compared to SCIT monotherapy [ Time Frame: Baseline to week 17 ]
  8. Change from baseline (last pretreatment measurement) to week 17 in log-transformed value of serum Timothy Grass sIgG4 to Timothy Grass sIgE ratio for dupilumab + SCIT as compared to SCIT monotherapy [ Time Frame: Baseline to week 17 ]
  9. Incidence rate of treatment-emergent adverse events (TEAEs) through end of study [ Time Frame: Baseline to week 24 ]
  10. Incidence rate of serious TEAEs through end of study [ Time Frame: Baseline to week 24 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Male and female subjects aged 18 to 55
  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)

Key Exclusion Criteria:

  1. Significant rhinitis, sinusitis, outside of the grass pollen season
  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

Note: Other protocol defined inclusion/ exclusion criteria apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558997


Contacts
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
United States, California
Regeneron Investigational Site Recruiting
Los Angeles, California, United States, 90025
Regeneron Investigational Site Recruiting
Mountain View, California, United States, 94040
Regeneron Investigational Site Recruiting
Walnut Creek, California, United States, 94598
United States, Colorado
Regeneron Investigational Site Recruiting
Denver, Colorado, United States, 80206
United States, Illinois
Regeneron Investigational Site Recruiting
Chicago, Illinois, United States, 60637
United States, Maryland
Regeneron Investigational Site Recruiting
Baltimore, Maryland, United States, 21224
Regeneron Investigational Site Recruiting
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Regeneron Investigational Site Recruiting
Andover, Massachusetts, United States, 01810
Regeneron Investigational Site Recruiting
North Dartmouth, Massachusetts, United States, 02747
United States, Missouri
Regeneron Investigational Site Recruiting
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Regeneron Investigational Site Recruiting
Bellevue, Nebraska, United States, 68123
United States, Oregon
Regeneron Investigational Site Recruiting
Portland, Oregon, United States, 97202
United States, Rhode Island
Regeneron Investigational Site Recruiting
East Providence, Rhode Island, United States, 02914
United States, Washington
Regeneron Investigational Site Recruiting
Seattle, Washington, United States, 98115
United States, Wisconsin
Regeneron Investigational Site Recruiting
Madison, Wisconsin, United States, 53792-9988
Canada, Ontario
Regeneron Investigational Site Recruiting
Kingston, Ontario, Canada, K7L 2V7
Regeneron Investigational Site Recruiting
Mississauga, Ontario, Canada, L5A 3V4
Regeneron Investigational Site Recruiting
Ottawa, Ontario, Canada, K1G 6C6
Regeneron Investigational Site Recruiting
Toronto, Ontario, Canada, M4V 1R2
Canada, Quebec
Regeneron Investigational Site Recruiting
Québec, Quebec, Canada, G1V 4W2
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03558997     History of Changes
Other Study ID Numbers: R668-ALG-16115
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs