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

November 12, 2020 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
      • Merksem, Belgium
  • Germany
      • Berlin, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Kiel, Germany
      • Mönchengladbach, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1: Dose 1
Drug CNTO7160 or Placebo administered IV infusion Dose 1.
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).
Drug: Part 1 and Part 2: Placebo
Participants will receive single IV infusion of placebo matched to CNTO 7160.
Experimental: Part 1: Dose 2
Drug CNTO7160 or Placebo administered IV infusion Dose 2.
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).
Drug: Part 1 and Part 2: Placebo
Participants will receive single IV infusion of placebo matched to CNTO 7160.
Experimental: Part 1: Dose 3
Drug CNTO7160 or Placebo administered IV infusion Dose 3.
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).
Drug: Part 1 and Part 2: Placebo
Participants will receive single IV infusion of placebo matched to CNTO 7160.
Experimental: Part 1: Dose 4
Drug CNTO7160 or Placebo administered IV infusion Dose 4.
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).
Drug: Part 1 and Part 2: Placebo
Participants will receive single IV infusion of placebo matched to CNTO 7160.
Experimental: Part 1: Dose 5
Drug CNTO7160 or Placebo administered IV infusion Dose 5.
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).
Drug: Part 1 and Part 2: Placebo
Participants will receive single IV infusion of placebo matched to CNTO 7160.
Experimental: Part 1: Dose 6
Drug CNTO7160 or Placebo administered IV infusion Dose 6.
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).
Drug: Part 1 and Part 2: Placebo
Participants will receive single IV infusion of placebo matched to CNTO 7160.
Experimental: Part 1: Dose 7
Drug CNTO7160 or Placebo administered IV infusion Dose 7.
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).
Drug: Part 1 and Part 2: Placebo
Participants will receive single IV infusion of placebo matched to CNTO 7160.
Experimental: Part 1: Dose 8
Drug CNTO7160 or Placebo administered IV infusion Dose 8.
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).
Drug: Part 1 and Part 2: Placebo
Participants will receive single IV infusion of placebo matched to CNTO 7160.
Experimental: Part 1: Dose 9
Drug CNTO7160 or Placebo administered IV infusion Dose 9.
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).
Drug: Part 1 and Part 2: Placebo
Participants will receive single IV infusion of placebo matched to CNTO 7160.
Experimental: Part 2 (Asthma): Dose 1
Drug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks).
Drug: Part 1 and Part 2: Placebo
Participants will receive single IV infusion of placebo matched to CNTO 7160.
Drug: Part 2 (Asthma): CNTO 7160
Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
Experimental: Part 2 (Asthma): Dose 2
Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks).
Drug: Part 1 and Part 2: Placebo
Participants will receive single IV infusion of placebo matched to CNTO 7160.
Drug: Part 2 (Asthma): CNTO 7160
Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
Experimental: Part 2 (Atopic Dermatitis): Dose 1
Drug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks).
Drug: Part 1 and Part 2: Placebo
Participants will receive single IV infusion of placebo matched to CNTO 7160.
Drug: Part 2 (Atopic Dermatitis): CNTO 7160
Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
Experimental: Part 2 (Atopic Dermatitis): Dose 2
Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks).
Drug: Part 1 and Part 2: Placebo
Participants will receive single IV infusion of placebo matched to CNTO 7160.
Drug: Part 2 (Atopic Dermatitis): CNTO 7160
Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO 7160 (Part 1)
Time Frame: Through Week 17
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)
Time Frame: Through Week 21
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Through Week 21

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Serum Concentration (Cmax) (Part 1)
Time Frame: Up to Week 17 after dose
Cmax (microgram per millileter [mcg/mL]) will be summarized by treatment group.
Up to Week 17 after dose
Maximum Observed Serum Concentration (Cmax) (Part 2)
Time Frame: Up to Week 21 after dose
Cmax (mcg/mL) after the first and last dose will be summarized by treatment group.
Up to Week 21 after dose
Area Under the Serum Time Curve [AUC(0-t) and AUC(0-infinity)] (Part 1)
Time Frame: Up to Week 17 after dose
AUC (mcg*day/mL) will be summarized by treatment group.
Up to Week 17 after dose
Area Under the Serum Concentration Versus Time Curve [AUC(t1-t2)] (Part 2)
Time Frame: Up to Week 21 after dose
AUC (mcg*day/mL) will be summarized by treatment group.
Up to Week 21 after dose
Number of Participants With Antibodies to CNTO 7160 (Part 1)
Time Frame: Up to Week 17
The incidence of participants with anti-CNTO 7160 antibodies will be summarized by treatment group.
Up to Week 17
Number of Participants with Antibodies to CNTO 7160 (Part 2)
Time Frame: Up to Week 21
The incidence of participants with anti-CNTO 7160 antibodies will be summarized by treatment group.
Up to Week 21
Change From Baseline in Immunoglobulin E (IgE) (Part 2)
Time Frame: Baseline, Week 21
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
Change from Baseline in Chemokine (C-C motif) Ligand 17 (CCL17) (Part 2)
Time Frame: Baseline, Week 21
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
Change From Baseline in Forced Expiratory Volume in 1 second (FEV1) in Participants With Asthma
Time Frame: Baseline Up to week 21
Changes in FEV1 (liter [L]) from baseline through end of follow up will be summarized by treatment group.
Baseline Up to week 21
Change From Baseline in Eczema Area Severity Index (EASI) in Participants With Atopic Dermatitis
Time Frame: Baseline up to week 21
Changes in EASI score from baseline through the end of follow up will be summarized by treatment group.
Baseline up to week 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR105130
  • CNTO7160ASH1001 (Other Identifier: Janssen Research & Development LLC.)
  • 2014-000633-23 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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