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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT02237196
First received: September 9, 2014
Last updated: March 17, 2017
Last verified: March 2017
September 9, 2014
March 17, 2017
October 2014
February 26, 2019   (Final data collection date for primary outcome measure)
Total Nasal Symptom Score (TNSS) area under the curve (AUC) from 0 to 1 hour after cat allergen challenge [ Time Frame: 104 weeks ]
TNSS is calculated with a scale of 0 to 3 on the 4 parameters of sneezing, rhinorrhea, nasal congestion and blockade, and pruritus. Maximum score is 12
Same as current
Complete list of historical versions of study NCT02237196 on ClinicalTrials.gov Archive Site
  • Allergic response: Skin prick test endpoint titration [ Time Frame: At baseline, 1, 4, 12, 52, 78 and 104 weeks ]
  • Allergic response: Skin early phase response (EPR) to intradermal testing [ Time Frame: At baseline, 52, 78, 104 weeks. ]
    EPR is the skin response at 15 minutes
  • Allergic response: Skin late phase response (LPR) to intradermal testing [ Time Frame: At baseline, 52 and 104 weeks. ]
    LPR is the skin response at 6 hours
  • Allergic response: Peak TNSS EPR [ Time Frame: At baseline, 52, 78 and 104 weeks ]
    Peak is the highest value recorded between 0 and 1 hour inclusive
  • Allergic response: TNSS EPR [ Time Frame: At baseline, 52, 78 and 104 weeks ]
    EPR is the TNSS AUC from 0 to 1 hour
  • Allergic response: TNSS LPR [ Time Frame: At baseline, 52 and 104 weeks ]
    LPR is the TNSS AUC from 5 to 6 hours
  • Allergic response: Peak Nasal Inspiratory Flow (PNIF) LPR AUC [ Time Frame: At baseline, 52 and 104 weeks ]
    LPR is the PNIF AUC from 5 to 6 hours
  • Allergic response: PNIF EPR AUC [ Time Frame: At baseline, 52, 78 and 104 weeks ]
    EPR is the PNIF AUC from 0 to 1 hour
  • Allergic response: Skin prick test endpoint titration [ Time Frame: At baseline, 1, 4, 12, 52, 78 and 104 weeks ]
  • Allergic response: Skin early phase response (EPR) to intradermal testing. [ Time Frame: At baseline, 52, 78, 104 weeks. ]
    EPR is the skin response at 15 minutes.
  • Allergic response: Skin late phase response (LPR) to intradermal testing. [ Time Frame: At baseline, 52 and 104 weeks. ]
    LPR is the skin response at 6 hours.
  • Allergic response: Peak TNSS EPR [ Time Frame: At baseline, 52, 78 and 104 weeks. ]
    Peak is the highest value recorded between 0 and 1 hour inclusive.
  • Allergic response: TNSS EPR [ Time Frame: At baseline, 52, 78 and 104 weeks. ]
    EPR is the TNSS AUC from 0 to 1 hour.
  • Allergic response: TNSS LPR [ Time Frame: At baseline, 52 and 104 weeks. ]
    LPR is the TNSS AUC from 5 to 6 hours.
  • Allergic response: Peak Nasal Inspiratory Flow (PNIF) LPR AUC. [ Time Frame: At baseline, 52 and 104 weeks. ]
    LPR is the PNIF AUC from 5 to 6 hours.
  • Allergic response: PNIF EPR AUC [ Time Frame: At baseline, 52, 78 and 104 weeks ]
    EPR is the PNIF AUC from 0 to 1 hour.
Not Provided
Not Provided
 
Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
  • Cat Allergy
  • Cat Hypersensitivity
  • Biological: 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.
    Other Name: MEDI9929/AMG 157
  • Biological: 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
    Other Name: Cat Allergen Extract
  • Biological: Cat Immunotherapy Placebo
    Placebo for allergen-specific immunotherapy administered subcutaneously
    Other Name: Placebo for Cat Immunotherapy
  • Biological: AMG 157 Placebo
    Placebo for AMG 157 administered intravenously
    Other Name: Placebo for AMG157
  • Experimental: AMG 157+Cat Immunotherapy

    AMG 157 will be administered every four weeks.

    Cat immunotherapy will be administered weekly.

    Interventions:
    • Biological: AMG 157
    • Biological: Cat Immunotherapy
  • Active Comparator: AMG 157 Placebo+Cat Immunotherapy

    Placebo for AMG 157 of similar appearance will be administered every four weeks.

    Cat immunotherapy will be administered weekly.

    Interventions:
    • Biological: Cat Immunotherapy
    • Biological: AMG 157 Placebo
  • Experimental: AMG 157+Cat Immunotherapy Placebo

    AMG 157 will be administered every four weeks.

    Placebo for Cat immunotherapy will be administered weekly.

    Interventions:
    • Biological: AMG 157
    • Biological: Cat Immunotherapy Placebo
  • Placebo Comparator: Placebo-Placebo

    Placebo for AMG 157 will be administered every four weeks.

    Placebo for cat immunotherapy will be administered weekly.

    Interventions:
    • Biological: Cat Immunotherapy Placebo
    • Biological: AMG 157 Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
February 26, 2019
February 26, 2019   (Final data collection date for primary outcome measure)

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 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:

  • 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)
  • 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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02237196
DAIT ITN057AD
CATNIP ( Other Identifier: Immune Tolerance Network )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: 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.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Study Chair: Jonathan Corren, MD University of California, Los Angeles
National Institute of Allergy and Infectious Diseases (NIAID)
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP