Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy
NCT ID: NCT02237196
Last Updated: 2020-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
121 participants
INTERVENTIONAL
2015-03-03
2019-03-04
Brief Summary
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Detailed Description
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CATNIP will be conducted at multiple sites in the US and enroll cat-allergic adults who will be randomized to four possible treatment groups: immunotherapy plus MEDI9929/AMG 157, immunotherapy plus placebo, placebo plus MEDI9929/AMG 157, or two corresponding placebos. This study is specifically enrolling cat allergic individuals who do not live with cats in order to limit exposure to the allergen outside of the study. Treatment will be given for about one year, followed by one year off therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AMG 157+Cat Immunotherapy
AMG 157 will be administered every four weeks.
Cat immunotherapy will be administered weekly.
AMG 157
AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy
A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
AMG 157 Placebo+Cat Immunotherapy
Placebo for AMG 157 of similar appearance will be administered every four weeks.
Cat immunotherapy will be administered weekly.
Cat Immunotherapy
A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
AMG 157 Placebo
Placebo for AMG 157 administered intravenously
AMG 157+Cat Immunotherapy Placebo
AMG 157 will be administered every four weeks.
Placebo for Cat immunotherapy will be administered weekly.
AMG 157
AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy Placebo
Placebo for allergen-specific immunotherapy administered subcutaneously
Placebo-Placebo
Placebo for AMG 157 will be administered every four weeks.
Placebo for cat immunotherapy will be administered weekly.
Cat Immunotherapy Placebo
Placebo for allergen-specific immunotherapy administered subcutaneously
AMG 157 Placebo
Placebo for AMG 157 administered intravenously
Interventions
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AMG 157
AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy
A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
Cat Immunotherapy Placebo
Placebo for allergen-specific immunotherapy administered subcutaneously
AMG 157 Placebo
Placebo for AMG 157 administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Skin prick test wheal \>/=5 mm to standardized cat extract
* Immunoglobulin E (IgE) \>/=0.7 kU/L (class 2) to cat extract
* Screening nasal allergen challenge in which:
\*TNSS is \</= 3 after the 0 concentration (vehicle control only) dose,
* TNSS increase is \</=1 from the TNSS prior to allergen administration to the TNSS after the 0 concentration (vehicle control only) dose,
* TNSS is \>/=8 after the highest dose, and
* Between the first non-zero dose and 10 minutes after the highest dose,either:
* \>/=3 sneezes are counted or
* \>20% drop in PNIF is recorded
* Body mass index (BMI) between 1 and 32 kg/m\^2, inclusive at screening
* Clinically acceptable physical examination and electrocardiogram (ECG) results (12-lead reporting RR, PR, QRS, QT and QTcF) prior to Day 0 based on the opinion of the investigator
* Adequate renal function (defined by creatinine clearance \>80 mL/min using the Cockcroft Gault equation)
* For women of childbearing age, a willingness to use a highly effective form of contraception for five months after last dose of study medication. Highly effective methods of birth control include abstinence, vasectomy by the male partner, or a condom with spermicide in combination with either hormonal birth control, IUD or barrier methods used by the woman.
* For men with female partners of childbearing potential, agreement not to donate sperm and to inform their female partner of their participation in this clinical study and use highly effective methods of birth control for five months after last dose of study medication. Highly effective methods of birth control include abstinence, vasectomy, or a condom with spermicide in combination with either hormonal birth control, Intrauterine device (IUD) or barrier methods used by the woman.
* The ability to give informed consent and comply with study procedures
Exclusion Criteria
* History of moderate or higher Allergic Rhinitis and its Impact on Asthma (ARIA) severity classification for allergic rhinitis in the last year due to allergens other than cat
* History of asthma meeting the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3 (EPR3) classification of mild-persistent or worse in the past year, other than with cat exposure, requiring regular inhaled corticosteroids for \>4 weeks per year
* History of serious chronic medical conditions which might interfere with treatment or assessments
* History of emergency visit or hospital admission for asthma in the previous 12 months
* History of chronic obstructive pulmonary disease (COPD)
* History of significant recurrent acute sinusitis, defined as 2 episodes/yr for the last 2 years, all of which required antibiotic treatment
* History of chronic sinusitis, defined as a sinus symptoms lasting \>12 weeks that includes \>/=2 major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, purulent or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, and ear pain, pressure, or fullness.
* History of systemic disease affecting the immune system such as autoimmune diseases, immune complex disease, or immunodeficiency, where, in the opinion of the study physician, participation in the trial would pose a risk or significant effect on the immune system
* Diabetes (Type I or II)
* Evidence of any active or suspected bacterial, viral, fungal or parasitic infection(s) within 30 days prior to randomization
* High risk of parasitic disease as judged by the investigator
* Positive QuantiFERON(R) tuberculin test UNLESS the potential subject has been treated with appropriate chemoprophylaxis
* Exposure to an individual with active tuberculosis within six months from randomization
* Subjects tested positive for HIV antibody, Hep B surface antigen, or Hep C antibody
* At randomization, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media, or other relevant infectious process; serous otitis media is not an exclusion criterion. Participants may be re-evaluated for eligibility after symptoms resolve.
* History of malignancy of any type, including basal cell and squamous cell cancers of the skin, within 5 years of enrollment
* Tobacco smoking (ANY) within the last year or a history of \>/=10 pack years
* Previous immunotherapy treatment with cat allergen within the previous 10 yrs
* Any history of grade 4 anaphylaxis due to any cause as defined by the CTCAE grading criteria for immunotherapy
* History of bleeding disorders or treatment with anticoagulation therapy
* Treatment with omalizumab within 6 months prior to randomization
* Currently taking any of the following medications: beta blockers; tricyclic antidepressants; monoamine oxidase inhibitors; or anti-IgE monoclonal antibody treatment
* Ongoing systemic immunosuppressive treatment
* History of intolerance to the study therapy, rescue medications, or their excipients
* For women of childbearing age a positive serum or urine pregnancy test with sensitivity of \<50 mIU/mL within 72 hours before the start of study therapy
* The use of any investigational drug within 6 months of randomization
* The presence of any medical condition that the investigator deems incompatible with participation in the trial.
18 Years
65 Years
ALL
No
Sponsors
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Immune Tolerance Network (ITN)
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Jonathan Corren, MD
Role: STUDY_CHAIR
University of California, Los Angeles
Locations
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University of California, Los Angeles
Los Angeles, California, United States
National Jewish Health
Denver, Colorado, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Johns Hopkins Asthma & Allergy Center
Baltimore, Maryland, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States
ASTHMA Inc. Clinical Research Center
Seattle, Washington, United States
University Wisconsin, Madison
Madison, Wisconsin, United States
Countries
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References
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Corren J, Larson D, Altman MC, Segnitz RM, Avila PC, Greenberger PA, Baroody F, Moss MH, Nelson H, Burbank AJ, Hernandez ML, Peden D, Saini S, Tilles S, Hussain I, Whitehouse D, Qin T, Villarreal M, Sever M, Wheatley LM, Nepom GT, Sanda S; Immune Tolerance Network ITN057AD CATNIP Study Team. Effects of combination treatment with tezepelumab and allergen immunotherapy on nasal responses to allergen: A randomized controlled trial. J Allergy Clin Immunol. 2023 Jan;151(1):192-201. doi: 10.1016/j.jaci.2022.08.029. Epub 2022 Oct 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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National Institute of Allergy and Infectious Diseases (NIAID)
Division of Allergy, Immunology, and Transplantation (DAIT)
Immune Tolerance Network (ITN) Website
World Allergy Organization (WAO) Subcutaneous Immunotherapy Systemic Reaction Grading System
Other Identifiers
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CATNIP
Identifier Type: OTHER
Identifier Source: secondary_id
DAIT ITN057AD
Identifier Type: -
Identifier Source: org_study_id
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