Trial · NCT02237196
Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy
NCT02237196, Phase 1, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2020-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy. Trials, record NCT02237196. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02237196
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy
- NCT number
- NCT02237196
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 121 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Cat Allergy, Cat Hypersensitivity
- Interventions
- AMG 157, Cat Immunotherapy, Cat Immunotherapy Placebo, AMG 157 Placebo
- First posted
- 2014-09-11
- Last updated
- 2020-05-06
- Results first posted
- 2020-05-06
- Limitations and caveats
- None listed
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC) | 0 to 1 hour of the NAC at Week 104 | 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 Challenge at 104 weeks by treatment group, using a longitudinal repeated measures model in the ITT sample. The model included fixed effects for treatment, time, and treatment by time interaction and included covariates for site, baseline TNSS AUC and Baseline Cat exposure (low vs high). The primary endpoint was assessed at week 104 using a contrast in least squares means between the following groups: AMG 157+Cat Immunotherapy and AMG 157 Placebo+Cat Immunotherapy. |
| Secondary | Skin Prick Test Endpoint Titration | 15 minutes after Time 0 of the skin prick titration test at: Baseline (Week 0) and Weeks 1, 4, 12, 26, 52, 78 and 104 | A dilution series of standardized cat allergen extracts were applied in duplicate on the participant's upper back. Wheal size was assessed 15 minutes after application. |
| Secondary | Skin Early Phase Response (EPR) to Intradermal Testing | 15 minutes after Time 0 of the intradermal test at: Baseline (Week 0) and Weeks 26, 52, and 104 | Concentrations of standardized cat hair extract were applied intradermally to the forearm. Wheal size was measured 15 minutes and 6 hours after application. The Early Phase Response (EPR) is the response measured at 15 minutes after application. |
| Secondary | Skin Late Phase Response (LPR) to Intradermal Testing | 6 hours status post cat allergen challenge at: Baseline (Time 0) and Weeks 26, 52 and 104 | Concentrations of standardized cat hair extract were applied intradermally to the forearm. Wheal size was measured 15 minutes and 6 hours after application. The Late Phase Response (LPR) is the response measured at 6 hours after application. |
| Secondary | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104 | 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. Peak TNSS EPR is the highest value recorded between 0 and 1 hour inclusive. |
| Secondary | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104 | 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 Early Phase Response (EPR) is the TNSS AUC from 0 to 1 hour. |
| Secondary | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, and 104 | 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 Late Phase Response (LPR) is the TNSS AUC from 5 to 6 hours. |
| Secondary | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52 and 104 | PNIF is defined as the speed of inspiration of air in Liters per minute when breathing in into the lungs through the nose. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. The Early Phase Response (EPR) is the PNIF AUC from 0 to 1 hour of the NAC. |
| Secondary | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78, and 104 | PNIF is defined as the speed of inspiration of air in Liters per minute when breathing in into the lungs through the nose. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. The Late Phase Response (LPR) is the PNIF AUC from hours 5 to 6 of the NAC. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC) | 0 to 1 hour of the NAC at Week 104 | Intent-to-treat | Total Nasal Symptom Score * Hour | LEAST_SQUARES_MEAN |
| SECONDARY | Skin Prick Test Endpoint Titration | 15 minutes after Time 0 of the skin prick titration test at: Baseline (Week 0) and Weeks 1, 4, 12, 26, 52, 78 and 104 | A cross-sectional analysis of the observed measures within the intent-to-treat population was used in the reporting of secondary endpoints. | mm | MEAN |
| SECONDARY | Skin Early Phase Response (EPR) to Intradermal Testing | 15 minutes after Time 0 of the intradermal test at: Baseline (Week 0) and Weeks 26, 52, and 104 | A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints. | mm | MEAN |
| SECONDARY | Skin Late Phase Response (LPR) to Intradermal Testing | 6 hours status post cat allergen challenge at: Baseline (Time 0) and Weeks 26, 52 and 104 | A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints. | mm | MEAN |
| SECONDARY | Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR) | 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104 | A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints. | Peak Total Nasal Symptom Score | MEAN |
| SECONDARY | Total Nasal Symptom Score (TNSS) Early Phase Response (EPR) | 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104 | A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints. | Total Nasal Symptom Score * Hour | MEAN |
| SECONDARY | Total Nasal Symptom Score (TNSS) Late Phase Response (LPR) | Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, and 104 | A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints. | Total Nasal Symptom Score * Hour | MEAN |
| SECONDARY | Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC) | 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52 and 104 | A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints. | L/min * Hour | MEAN |
| SECONDARY | Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC | Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78, and 104 | A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints. | L/min * Hour | MEAN |
Source ClinicalTrials.gov
Results by group160
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC) | AMG 157+Cat Immunotherapy | 2.46 | 95% Confidence Interval 1.73 to 3.19 | Total Nasal Symptom Score * Hour | |
| Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC) | AMG 157 Placebo+Cat Immunotherapy | 2.81 | 95% Confidence Interval 2.13 to 3.49 | Total Nasal Symptom Score * Hour | |
| Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC) | AMG 157+Cat Immunotherapy Placebo | 3.66 | 95% Confidence Interval 2.74 to 4.59 | Total Nasal Symptom Score * Hour | |
| Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC) | Placebo-Placebo | 3.10 | 95% Confidence Interval 2.11 to 4.10 | Total Nasal Symptom Score * Hour | |
| Skin Prick Test Endpoint Titration | AMG 157+Cat Immunotherapy | Baseline | 45.11 | 95% Confidence Interval 40.74 to 49.49 | mm |
| Skin Prick Test Endpoint Titration | AMG 157 Placebo+Cat Immunotherapy | Baseline | 46.29 | 95% Confidence Interval 38.88 to 53.69 | mm |
| Skin Prick Test Endpoint Titration | AMG 157+Cat Immunotherapy Placebo | Baseline | 45.01 | 95% Confidence Interval 40.17 to 49.84 | mm |
| Skin Prick Test Endpoint Titration | Placebo-Placebo | Baseline | 44.49 | 95% Confidence Interval 38.25 to 50.73 | mm |
| Skin Prick Test Endpoint Titration | AMG 157+Cat Immunotherapy | Week 1 | 45.92 | 95% Confidence Interval 38.08 to 53.77 | mm |
| Skin Prick Test Endpoint Titration | AMG 157 Placebo+Cat Immunotherapy | Week 1 | 50.25 | 95% Confidence Interval 42.22 to 58.28 | mm |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AMG 157+Cat Immunotherapy | 32 | |
| Overall Study | STARTED | AMG 157 Placebo+Cat Immunotherapy | 31 | |
| Overall Study | STARTED | AMG 157+Cat Immunotherapy Placebo | 30 | |
| Overall Study | STARTED | Placebo-Placebo | 28 | |
| Overall Study | COMPLETED | AMG 157+Cat Immunotherapy | 24 | |
| Overall Study | COMPLETED | AMG 157 Placebo+Cat Immunotherapy | 25 | |
| Overall Study | COMPLETED | AMG 157+Cat Immunotherapy Placebo | 20 | |
| Overall Study | COMPLETED | Placebo-Placebo | 17 | |
| Overall Study | NOT COMPLETED | AMG 157+Cat Immunotherapy | 8 | |
| Overall Study | NOT COMPLETED | AMG 157 Placebo+Cat Immunotherapy | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events152
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | AMG 157+Cat Immunotherapy | 0 | 32 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | AMG 157 Placebo+Cat Immunotherapy | 0 | 31 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | AMG 157+Cat Immunotherapy Placebo | 0 | 29 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo-Placebo | 2 | 28 | 2 |
| other | Food poisoning | Gastrointestinal disorders | AMG 157+Cat Immunotherapy | 0 | 32 | 0 |
| other | Food poisoning | Gastrointestinal disorders | AMG 157 Placebo+Cat Immunotherapy | 1 | 31 | 1 |
| other | Food poisoning | Gastrointestinal disorders | AMG 157+Cat Immunotherapy Placebo | 2 | 29 | 2 |
| other | Food poisoning | Gastrointestinal disorders | Placebo-Placebo | 0 | 28 | 0 |
| other | Nausea | Gastrointestinal disorders | AMG 157+Cat Immunotherapy | 1 | 32 | 1 |
| other | Nausea | Gastrointestinal disorders | AMG 157 Placebo+Cat Immunotherapy | 1 | 31 | 1 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AMG 157+Cat Immunotherapy | 0 | 32 |
| Total, all-cause mortality | AMG 157 Placebo+Cat Immunotherapy | 0 | 31 |
| Total, all-cause mortality | AMG 157+Cat Immunotherapy Placebo | 0 | 29 |
| Total, all-cause mortality | Placebo-Placebo | 0 | 28 |
| Total, other adverse events | AMG 157+Cat Immunotherapy | 25 | 32 |
| Total, other adverse events | AMG 157 Placebo+Cat Immunotherapy | 18 | 31 |
| Total, other adverse events | AMG 157+Cat Immunotherapy Placebo | 18 | 29 |
| Total, other adverse events | Placebo-Placebo | 19 | 28 |
| Total, serious adverse events | AMG 157+Cat Immunotherapy | 1 | 32 |
| Total, serious adverse events | AMG 157 Placebo+Cat Immunotherapy | 3 | 31 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36223848 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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