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

NCT02345928 | Completed Phase 1

• 3 other identifiers: CR105130CNTO7160ASH10012014-000633-23
• Study Type: interventional
• Target: 108
• Locations: 2 countries
• Sites: 7

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.

Conditions

Asthma; Atopic Dermatitis; Healthy

Keywords

Safety; Efficacy; CNTO 7160; Healthy; Asthma; Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (10)

• Maximum Observed Serum Concentration (Cmax) (Part 1)

  Up to Week 17 after dose

• Maximum Observed Serum Concentration (Cmax) (Part 2)

  Up to Week 21 after dose

• Area Under the Serum Time Curve [AUC(0-t) and AUC(0-infinity)] (Part 1)

  Up to Week 17 after dose

• Area Under the Serum Concentration Versus Time Curve [AUC(t1-t2)] (Part 2)

  Up to Week 21 after dose

• Number of Participants With Antibodies to CNTO 7160 (Part 1)

  Up to Week 17

Study Arms (13)

Part 1: Dose 1

EXPERIMENTAL

Drug CNTO7160 or Placebo administered IV infusion Dose 1.

Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo

Part 1: Dose 2

EXPERIMENTAL

Drug CNTO7160 or Placebo administered IV infusion Dose 2.

Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo

Part 1: Dose 3

EXPERIMENTAL

Drug CNTO7160 or Placebo administered IV infusion Dose 3.

Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo

Part 1: Dose 4

EXPERIMENTAL

Drug CNTO7160 or Placebo administered IV infusion Dose 4.

Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo

Part 1: Dose 5

EXPERIMENTAL

Drug CNTO7160 or Placebo administered IV infusion Dose 5.

Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo

Part 1: Dose 6

EXPERIMENTAL

Drug CNTO7160 or Placebo administered IV infusion Dose 6.

Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo

Part 1: Dose 7

EXPERIMENTAL

Drug CNTO7160 or Placebo administered IV infusion Dose 7.

Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo

Part 1: Dose 8

EXPERIMENTAL

Drug CNTO7160 or Placebo administered IV infusion Dose 8.

Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo

Part 1: Dose 9

EXPERIMENTAL

Drug CNTO7160 or Placebo administered IV infusion Dose 9.

Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo

Part 2 (Asthma): Dose 1

EXPERIMENTAL

Drug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks).

Drug: Part 2 (Asthma): CNTO 7160; Drug: Part 1 and Part 2: Placebo

Part 2 (Asthma): Dose 2

EXPERIMENTAL

Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks).

Drug: Part 2 (Asthma): CNTO 7160; Drug: Part 1 and Part 2: Placebo

Part 2 (Atopic Dermatitis): Dose 1

EXPERIMENTAL

Drug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks).

Drug: Part 2 (Atopic Dermatitis): CNTO 7160; Drug: Part 1 and Part 2: Placebo

Part 2 (Atopic Dermatitis): Dose 2

EXPERIMENTAL

Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks).

Drug: Part 2 (Atopic Dermatitis): CNTO 7160; Drug: Part 1 and Part 2: Placebo

Interventions

Part 1: CNTO 7160 DRUG

Participants will receive Drug CNTO7160 administered IV infusion at escalating doses (with a starting dose of 0.001 mg/kg).

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): CNTO 7160 DRUG

Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).

Part 2 (Asthma): Dose 1; Part 2 (Asthma): Dose 2

Part 2 (Atopic Dermatitis): CNTO 7160 DRUG

Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).

Part 2 (Atopic Dermatitis): Dose 1; Part 2 (Atopic Dermatitis): Dose 2

Part 1 and Part 2: Placebo DRUG

Participants will receive single IV infusion of placebo matched to CNTO 7160.

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (7)

Unknown Facility

Antwerp, Belgium

Location

Unknown Facility

Merksem, Belgium

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Mönchengladbach, Germany

Location

Related 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 with asthma or atopic dermatitis. Br J Clin Pharmacol. 2020 Dec;86(12):2507-2518. doi: 10.1111/bcp.14361. Epub 2020 Jun 14.

  PMID: 32415720 RESULT

MeSH Terms

Conditions

Asthma; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: January 26, 2015
• Study Start: August 5, 2014
• Primary Completion: March 16, 2017
• Study Completion: March 16, 2017
• Last Updated: November 16, 2020

Record last verified: 2020-11

Locations

BE (2); DE (5)