Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals… (NCT02237196) | Clinical Trial Compass
CompletedPhase 1/2
Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy
United States121 participantsStarted 2015-03-03
Plain-language summary
This trial will test whether a novel therapeutic approach, cat immunotherapy combined with an investigational new drug called MEDI9929/AMG 157 (an anti-TSLP \[thymic stromal lymphopoietin\] antibody being co-developed by Amgen and MedImmune) can lead to lasting tolerance to cat allergen.The objective of the study is to determine whether one year of immunotherapy combined with MEDI9929/AMG 157 can induce tolerance to cat allergen.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* History of moderate-severe allergic rhinitis caused by cat exposure for at least 2 yrs
* 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 …
What they're measuring
1
Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC)
Timeframe: 0 to 1 hour of the NAC at Week 104
Trial details
NCT IDNCT02237196
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)