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NCT02237196 · ClinicalTrials.gov registry record · Phase 1
Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 121
- Enrollment target
NCT02237196: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02237196 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 121 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (102% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02237196, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 121 participants
- Enrollment target
Study 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.
Primary Outcome
TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The primary outcome compared the mean TNSS AUC from 0 to 1 hour after cat Nasal Allergen Chal
Interventions
- BIOLOGICAL AMG 157
- BIOLOGICAL Cat Immunotherapy
- BIOLOGICAL Cat Immunotherapy Placebo
- BIOLOGICAL AMG 157 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2015-03-03 |
| Est. Completion | 2019-03-04 |
| Phase | Phase 1 |
What the finished NCT02237196 record still lists
NCT02237196 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (102% higher).
The record links to 0 conditions, and to 4 interventions - of which AMG 157 is the first listed.
NCT02237196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02237196 about?
NCT02237196 is a clinical study titled "Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy". 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 objectiv...
What is the current status of trial NCT02237196?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 121 participants. The study started on 2015-03-03. Estimated completion is 2019-03-04.
What interventions are being tested in trial NCT02237196?
The interventions under investigation include: AMG 157 (BIOLOGICAL), Cat Immunotherapy (BIOLOGICAL), Cat Immunotherapy Placebo (BIOLOGICAL), AMG 157 Placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT02237196?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02237196's enrollment target sits among peer trials
121 476th of 2000 higher than 1,522 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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