Back to resultsA Single Ascending Dose Study in Healthy Participants and Multiple Ascending Dose Study of CNTO 7160 in Participants With Asthma and Participants With Atopic Dermatitis
Primary Purpose
Asthma, Atopic Dermatitis, Healthy
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Part 1: CNTO 7160
Part 2 (Asthma): CNTO 7160
Part 2 (Atopic Dermatitis): CNTO 7160
Part 1 and Part 2: Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Safety, Efficacy, CNTO 7160, Healthy, Asthma, Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
- Part 1 (Healthy Participants): Participant must have a body weight in the range of 50 to 100 kilogram (kg) inclusive and have a body mass index (BMI) of 19 to 30 kilogram per meter square (kg/m^2) inclusive
- Part 1 (Healthy Participants): Participant must be healthy on the basis of physical examination, medical history, vital signs and 12-lead ECG performed at screening
- Part 2 (Asthma Participants): Participant must have a body weight in the range of 50 to 125 kg inclusive and have a BMI of 19 to 32 kg/m^2 inclusive
- Part 2 (Asthma Participants): Participant must have a physician documented diagnosis of asthma for at least 12 months before screening
- Part 2 (Atopic Dermatitis Participants): Participant must have a body weight in the range of 50 to 100 kg inclusive and have a BMI of 19 to 30 kg/m^2 inclusive
- Part 2 (Atopic Dermatitis Participants): Participant has physician documented diagnosis of atopic dermatitis for at least 12 months before screening based on UK refinements of the Rajka and Hanifin criteria
Exclusion Criteria:
- Part 1 (Healthy Participants): Participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit
- Part 1 (Healthy Participants): Participant currently has or has a history of any clinically significant cardiovascular disease, including but not limited to a history of angina or myocardial infarction, congestive heart failure, symptomatic atherosclerotic vascular disease, or arrhythmia.
- Part 2 (Asthma Participants): Participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit
- Part 2 (Asthma Participants): Participant has or have had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received IV antibiotics for a serious infection during the 4 months prior to the Screening Visit
- Part 2 (Atopic Dermatitis Participants): Participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit.
- Part 2 (Atopic Dermatitis Participants): Participant has or have had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received IV antibiotics for a serious infection during the 4 months prior to the Screening Visit
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Part 1: Dose 1
Part 1: Dose 2
Part 1: Dose 3
Part 1: Dose 4
Part 1: Dose 5
Part 1: Dose 6
Part 1: Dose 7
Part 1: Dose 8
Part 1: Dose 9
Part 2 (Asthma): Dose 1
Part 2 (Asthma): Dose 2
Part 2 (Atopic Dermatitis): Dose 1
Part 2 (Atopic Dermatitis): Dose 2
Arm Description
Drug CNTO7160 or Placebo administered IV infusion Dose 1.
Drug CNTO7160 or Placebo administered IV infusion Dose 2.
Drug CNTO7160 or Placebo administered IV infusion Dose 3.
Drug CNTO7160 or Placebo administered IV infusion Dose 4.
Drug CNTO7160 or Placebo administered IV infusion Dose 5.
Drug CNTO7160 or Placebo administered IV infusion Dose 6.
Drug CNTO7160 or Placebo administered IV infusion Dose 7.
Drug CNTO7160 or Placebo administered IV infusion Dose 8.
Drug CNTO7160 or Placebo administered IV infusion Dose 9.
Drug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks).
Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks).
Drug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks).
Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks).
Outcomes
Primary Outcome Measures
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO 7160 (Part 1)
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO 7160 (Part 2)
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Secondary Outcome Measures
Maximum Observed Serum Concentration (Cmax) (Part 1)
Cmax (microgram per millileter [mcg/mL]) will be summarized by treatment group.
Maximum Observed Serum Concentration (Cmax) (Part 2)
Cmax (mcg/mL) after the first and last dose will be summarized by treatment group.
Area Under the Serum Time Curve [AUC(0-t) and AUC(0-infinity)] (Part 1)
AUC (mcg*day/mL) will be summarized by treatment group.
Area Under the Serum Concentration Versus Time Curve [AUC(t1-t2)] (Part 2)
AUC (mcg*day/mL) will be summarized by treatment group.
Number of Participants With Antibodies to CNTO 7160 (Part 1)
The incidence of participants with anti-CNTO 7160 antibodies will be summarized by treatment group.
Number of Participants with Antibodies to CNTO 7160 (Part 2)
The incidence of participants with anti-CNTO 7160 antibodies will be summarized by treatment group.
Change From Baseline in Immunoglobulin E (IgE) (Part 2)
Change from Baseline in immunoglobulin E (IgE) Concentration (international unit per millileter [IU/mL]) through Week 21 will be summarized by treatment group.
Change from Baseline in Chemokine (C-C motif) Ligand 17 (CCL17) (Part 2)
Change from Baseline in Chemokine (C-C motif) Ligand 17 (CCL17) concentration (picogram per millileter [pg/mL]) through Week 21 will be summarized by treatment group.
Change From Baseline in Forced Expiratory Volume in 1 second (FEV1) in Participants With Asthma
Changes in FEV1 (liter [L]) from baseline through end of follow up will be summarized by treatment group.
Change From Baseline in Eczema Area Severity Index (EASI) in Participants With Atopic Dermatitis
Changes in EASI score from baseline through the end of follow up will be summarized by treatment group.
Full Information
NCT ID
NCT02345928
First Posted
August 27, 2014
Last Updated
November 12, 2020
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02345928
Brief Title
A Single Ascending Dose Study in Healthy Participants and Multiple Ascending Dose Study of CNTO 7160 in Participants With Asthma and Participants With Atopic Dermatitis
Official Title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Ascending Dose Study of CNTO 7160 in Subjects With Asthma and Subjects With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 5, 2014 (Actual)
Primary Completion Date
March 16, 2017 (Actual)
Study Completion Date
March 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of single ascending dose of CNTO 7160 administered intravenously (IV) in healthy participants and multiple dose administered IV in participants with asthma and atopic dermatitis.
Detailed Description
This is a Phase 1, randomized, placebo-controlled, multicenter study of CNTO 7160. The study consists of Screening Period, In-patient period (6 days for healthy participants, 11 days for asthmatic participants and atopic dermatitis participants) and outpatient period (105 days for healthy participants, 110 days for asthmatic and atopic dermatitis participants). The total duration of participation for each participant will be approximately 21 weeks for healthy participants, 25 weeks for asthmatic participants, and atopic dermatitis participants. All eligible participants will be randomly assigned to receive active agent or placebo. The study will be conducted in 2 parts. In Part 1, single ascending doses of CNTO 7160 or placebo will be administered to sequential cohorts of healthy participants as an IV infusion. In Part 2, ascending multiple doses of CNTO 7160 or placebo will be administered as IV infusions to sequential cohorts of participants with asthma or atopic dermatitis. Blood samples will be collected for assessment of pharmacokinetic and pharmacodynamics parameters in both part 1 and 2 parameters, along with assessment of safety and clinical effects in part 2. Participants' safety will be monitored throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Atopic Dermatitis, Healthy
Keywords
Safety, Efficacy, CNTO 7160, Healthy, Asthma, Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1: Dose 1
Arm Type
Experimental
Arm Description
Drug CNTO7160 or Placebo administered IV infusion Dose 1.
Arm Title
Part 1: Dose 2
Arm Type
Experimental
Arm Description
Drug CNTO7160 or Placebo administered IV infusion Dose 2.
Arm Title
Part 1: Dose 3
Arm Type
Experimental
Arm Description
Drug CNTO7160 or Placebo administered IV infusion Dose 3.
Arm Title
Part 1: Dose 4
Arm Type
Experimental
Arm Description
Drug CNTO7160 or Placebo administered IV infusion Dose 4.
Arm Title
Part 1: Dose 5
Arm Type
Experimental
Arm Description
Drug CNTO7160 or Placebo administered IV infusion Dose 5.
Arm Title
Part 1: Dose 6
Arm Type
Experimental
Arm Description
Drug CNTO7160 or Placebo administered IV infusion Dose 6.
Arm Title
Part 1: Dose 7
Arm Type
Experimental
Arm Description
Drug CNTO7160 or Placebo administered IV infusion Dose 7.
Arm Title
Part 1: Dose 8
Arm Type
Experimental
Arm Description
Drug CNTO7160 or Placebo administered IV infusion Dose 8.
Arm Title
Part 1: Dose 9
Arm Type
Experimental
Arm Description
Drug CNTO7160 or Placebo administered IV infusion Dose 9.
Arm Title
Part 2 (Asthma): Dose 1
Arm Type
Experimental
Arm Description
Drug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks).
Arm Title
Part 2 (Asthma): Dose 2
Arm Type
Experimental
Arm Description
Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks).
Arm Title
Part 2 (Atopic Dermatitis): Dose 1
Arm Type
Experimental
Arm Description
Drug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks).
Arm Title
Part 2 (Atopic Dermatitis): Dose 2
Arm Type
Experimental
Arm Description
Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks).
Intervention Type
Drug
Intervention Name(s)
Part 1: CNTO 7160
Intervention Description
Participants will receive Drug CNTO7160 administered IV infusion at escalating doses (with a starting dose of 0.001 mg/kg).
Intervention Type
Drug
Intervention Name(s)
Part 2 (Asthma): CNTO 7160
Intervention Description
Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
Intervention Type
Drug
Intervention Name(s)
Part 2 (Atopic Dermatitis): CNTO 7160
Intervention Description
Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
Intervention Type
Drug
Intervention Name(s)
Part 1 and Part 2: Placebo
Intervention Description
Participants will receive single IV infusion of placebo matched to CNTO 7160.
Primary Outcome Measure Information:
Title
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO 7160 (Part 1)
Description
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Time Frame
Through Week 17
Title
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO 7160 (Part 2)
Description
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Time Frame
Through Week 21
Secondary Outcome Measure Information:
Title
Maximum Observed Serum Concentration (Cmax) (Part 1)
Description
Cmax (microgram per millileter [mcg/mL]) will be summarized by treatment group.
Time Frame
Up to Week 17 after dose
Title
Maximum Observed Serum Concentration (Cmax) (Part 2)
Description
Cmax (mcg/mL) after the first and last dose will be summarized by treatment group.
Time Frame
Up to Week 21 after dose
Title
Area Under the Serum Time Curve [AUC(0-t) and AUC(0-infinity)] (Part 1)
Description
AUC (mcg*day/mL) will be summarized by treatment group.
Time Frame
Up to Week 17 after dose
Title
Area Under the Serum Concentration Versus Time Curve [AUC(t1-t2)] (Part 2)
Description
AUC (mcg*day/mL) will be summarized by treatment group.
Time Frame
Up to Week 21 after dose
Title
Number of Participants With Antibodies to CNTO 7160 (Part 1)
Description
The incidence of participants with anti-CNTO 7160 antibodies will be summarized by treatment group.
Time Frame
Up to Week 17
Title
Number of Participants with Antibodies to CNTO 7160 (Part 2)
Description
The incidence of participants with anti-CNTO 7160 antibodies will be summarized by treatment group.
Time Frame
Up to Week 21
Title
Change From Baseline in Immunoglobulin E (IgE) (Part 2)
Description
Change from Baseline in immunoglobulin E (IgE) Concentration (international unit per millileter [IU/mL]) through Week 21 will be summarized by treatment group.
Time Frame
Baseline, Week 21
Title
Change from Baseline in Chemokine (C-C motif) Ligand 17 (CCL17) (Part 2)
Description
Change from Baseline in Chemokine (C-C motif) Ligand 17 (CCL17) concentration (picogram per millileter [pg/mL]) through Week 21 will be summarized by treatment group.
Time Frame
Baseline, Week 21
Title
Change From Baseline in Forced Expiratory Volume in 1 second (FEV1) in Participants With Asthma
Description
Changes in FEV1 (liter [L]) from baseline through end of follow up will be summarized by treatment group.
Time Frame
Baseline Up to week 21
Title
Change From Baseline in Eczema Area Severity Index (EASI) in Participants With Atopic Dermatitis
Description
Changes in EASI score from baseline through the end of follow up will be summarized by treatment group.
Time Frame
Baseline up to week 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Part 1 (Healthy Participants): Participant must have a body weight in the range of 50 to 100 kilogram (kg) inclusive and have a body mass index (BMI) of 19 to 30 kilogram per meter square (kg/m^2) inclusive
Part 1 (Healthy Participants): Participant must be healthy on the basis of physical examination, medical history, vital signs and 12-lead ECG performed at screening
Part 2 (Asthma Participants): Participant must have a body weight in the range of 50 to 125 kg inclusive and have a BMI of 19 to 32 kg/m^2 inclusive
Part 2 (Asthma Participants): Participant must have a physician documented diagnosis of asthma for at least 12 months before screening
Part 2 (Atopic Dermatitis Participants): Participant must have a body weight in the range of 50 to 100 kg inclusive and have a BMI of 19 to 30 kg/m^2 inclusive
Part 2 (Atopic Dermatitis Participants): Participant has physician documented diagnosis of atopic dermatitis for at least 12 months before screening based on UK refinements of the Rajka and Hanifin criteria
Exclusion Criteria:
Part 1 (Healthy Participants): Participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit
Part 1 (Healthy Participants): Participant currently has or has a history of any clinically significant cardiovascular disease, including but not limited to a history of angina or myocardial infarction, congestive heart failure, symptomatic atherosclerotic vascular disease, or arrhythmia.
Part 2 (Asthma Participants): Participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit
Part 2 (Asthma Participants): Participant has or have had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received IV antibiotics for a serious infection during the 4 months prior to the Screening Visit
Part 2 (Atopic Dermatitis Participants): Participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit.
Part 2 (Atopic Dermatitis Participants): Participant has or have had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received IV antibiotics for a serious infection during the 4 months prior to the Screening Visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Antwerp
Country
Belgium
City
Merksem
Country
Belgium
City
Berlin
Country
Germany
City
Hamburg
Country
Germany
City
Hannover
Country
Germany
City
Kiel
Country
Germany
City
Mönchengladbach
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
32415720
Citation
Nnane I, Frederick B, Yao Z, Raible D, Shu C, Badorrek P, van den Boer M, Branigan P, Duffy K, Baribaud F, Fink D, Yang TY, Xu Z. The first-in-human study of CNTO 7160, an anti-interleukin-33 receptor monoclonal antibody, in healthy subjects and patients with asthma or atopic dermatitis. Br J Clin Pharmacol. 2020 Dec;86(12):2507-2518. doi: 10.1111/bcp.14361. Epub 2020 Jun 14.
Results Reference
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Learn more about this trial
A Single Ascending Dose Study in Healthy Participants and Multiple Ascending Dose Study of CNTO 7160 in Participants With Asthma and Participants With Atopic Dermatitis
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