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Cat AllergyPhase 1/2NCT02237196

Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy

A Phase 1/2 study testing AMG 157 and Cat Immunotherapy in people with Cat Allergy and Cat Hypersensitivity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cat Allergy, Cat Hypersensitivity
What is being tested?
AMG 157 and Cat Immunotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
121 participants
Where
9 sitesUnited States
Study dates
3 Mar 2015to 4 Mar 2019
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 16Show fewer
  • 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

Who cannot join

  • Prebronchodilator Forced Expiratory Volume at one second (FEV1) less than 0% of predicted value at screening visit
  • 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)
Show all 28Show fewer
  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Johns Hopkins Asthma & Allergy Center

    Baltimore, Maryland, 21231

  • University of North Carolina, Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • National Jewish Health

    Denver, Colorado, 80206

  • University of California, Los Angeles

    Los Angeles, California, 90025

  • University Wisconsin, Madison

    Madison, Wisconsin, 53792

  • ASTHMA Inc. Clinical Research Center

    Seattle, Washington, 98115

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma, 74136

Other trials in United States

About this study

Official title: Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy (ITN057AD)

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.

Read the detailed description

This study will implement the concept referred to as "allergen-plus," which aims to enhance the disease-modifying mechanisms of allergen-specific immunotherapy by combining it with other anti-inflammatory or immune-modulating agents. Thymic stromal lymphopoietin (TSLP) is a cytokine which appears to be instrumental in both initiating and maintaining allergic sensitivity to antigens, and Immune Tolerance Network (ITN) investigators hypothesize that blocking TSLP during the administration of cat immunotherapy will induce durable immune changes that lead to tolerance.

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.

Being tested
AMG 157, Cat Immunotherapy, Cat Immunotherapy Placebo, AMG 157 Placebo
Keywords
cat-allergic, cat immunotherapy, anti-thymic stromal lymphopoietin (anti-TSLP)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMG 157Biological

    Also called MEDI9929/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 ImmunotherapyBiological

    Also called Cat Allergen Extract

    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 PlaceboBiological

    Also called Placebo for Cat Immunotherapy

    Placebo for allergen-specific immunotherapy administered subcutaneously

  • AMG 157 PlaceboBiological

    Also called Placebo for AMG157

    Placebo for AMG 157 administered intravenously

Study groups in NCT02237196
Study groupRoleWhat they receive
AMG 157+Cat ImmunotherapyExperimentalAMG 157 will be administered every four weeks. Cat immunotherapy will be administered weekly.
Receives: Biological: AMG 157; Biological: Cat Immunotherapy
AMG 157 Placebo+Cat ImmunotherapyActive comparatorPlacebo for AMG 157 of similar appearance will be administered every four weeks. Cat immunotherapy will be administered weekly.
Receives: Biological: Cat Immunotherapy; Biological: AMG 157 Placebo
AMG 157+Cat Immunotherapy PlaceboExperimentalAMG 157 will be administered every four weeks. Placebo for Cat immunotherapy will be administered weekly.
Receives: Biological: AMG 157; Biological: Cat Immunotherapy Placebo
Placebo-PlaceboPlacebo comparatorPlacebo for AMG 157 will be administered every four weeks. Placebo for cat immunotherapy will be administered weekly.
Receives: Biological: Cat Immunotherapy Placebo; Biological: AMG 157 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC)

    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.

    Measured: 0 to 1 hour of the NAC at Week 104

Secondary outcomes (8)

  1. Skin Prick Test Endpoint Titration

    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.

    Measured: 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

  2. Skin Early Phase Response (EPR) to Intradermal Testing

    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.

    Measured: 15 minutes after Time 0 of the intradermal test at: Baseline (Week 0) and Weeks 26, 52, and 104

  3. Skin Late Phase Response (LPR) to Intradermal Testing

    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.

    Measured: 6 hours status post cat allergen challenge at: Baseline (Time 0) and Weeks 26, 52 and 104

  4. Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR)

    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.

    Measured: 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104

  5. Total Nasal Symptom Score (TNSS) Early Phase Response (EPR)

    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.

    Measured: 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104

  6. Total Nasal Symptom Score (TNSS) Late Phase Response (LPR)

    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.

    Measured: Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, and 104

  7. Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC)

    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.

    Measured: 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52 and 104

  8. Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC

    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.

    Measured: Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78, and 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2014 (estimated)
  2. Study start3 Mar 2015
  3. Primary completion4 Mar 2019
  4. Study completion4 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02237196
Sponsor's protocol ID
DAIT ITN057AD
Other IDs
CATNIP
Status last verified
Apr 2020
First submitted
9 Sep 2014
Last updated
6 May 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The plan is to share data in upon completion of the study in: 1.)ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts; and 2.)TrialShare, a clinical trials research portal developed by the Immune Tolerance Network that makes data from the consortium's clinical trials publicly available.

Publications

  • 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.

    PubMed 36223848

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AMG 157 and Cat Immunotherapy in people with Cat Allergy and Cat Hypersensitivity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC) (time frame: 0 to 1 hour of the NAC at Week 104). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02237196, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020; AzTrials last refreshed its copy on 2 Nov 2026.

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