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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345928
• Other study ID #: CR105130
• Secondary ID: CNTO7160ASH10012
• Status: Completed
• Phase: Phase 1
• Start date: August 5, 2014
• Est. completion date: March 16, 2017

Study information

• Verified date: November 2020
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 16, 2017
• Est. primary completion date: March 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Healthy

Intervention

Drug:
• Part 1: CNTO 7160
Participants will receive Drug CNTO7160 administered IV infusion at escalating doses (with a starting dose of 0.001 mg/kg).
• Part 2 (Asthma): CNTO 7160
Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
• Part 2 (Atopic Dermatitis): CNTO 7160
Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
• Part 1 and Part 2: Placebo
Participants will receive single IV infusion of placebo matched to CNTO 7160.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

Belgium,  Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through Week 17
Primary	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.	Through Week 21
Secondary	Maximum Observed Serum Concentration (Cmax) (Part 1)	Cmax (microgram per millileter [mcg/mL]) will be summarized by treatment group.	Up to Week 17 after dose
Secondary	Maximum Observed Serum Concentration (Cmax) (Part 2)	Cmax (mcg/mL) after the first and last dose will be summarized by treatment group.	Up to Week 21 after dose
Secondary	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.	Up to Week 17 after dose
Secondary	Area Under the Serum Concentration Versus Time Curve [AUC(t1-t2)] (Part 2)	AUC (mcg*day/mL) will be summarized by treatment group.	Up to Week 21 after dose
Secondary	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.	Up to Week 17
Secondary	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.	Up to Week 21
Secondary	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.	Baseline, Week 21
Secondary	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.	Baseline, Week 21
Secondary	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.	Baseline Up to week 21
Secondary	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.	Baseline up to week 21