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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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ClinicalTrials.gov Identifier: NCT02345928
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Asthma Atopic Dermatitis Healthy Drug: Part 1: CNTO 7160 Drug: Part 2 (Asthma): CNTO 7160 Drug: Part 2 (Atopic Dermatitis): CNTO 7160 Drug: Part 1 and Part 2: Placebo Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 5, 2014
Actual Primary Completion Date : March 16, 2017
Actual Study Completion Date : March 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Eczema

Arm Intervention/treatment
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 2 (Asthma): CNTO 7160
Participants will receive Drug CNTO 7160 administered IV infusions (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.

Experimental: Part 2 (Asthma): Dose 2
Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks).
Drug: Part 2 (Asthma): CNTO 7160
Participants will receive Drug CNTO 7160 administered IV infusions (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.

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 2 (Atopic Dermatitis): CNTO 7160
Participants will receive Drug CNTO 7160 administered IV infusions (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.

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 2 (Atopic Dermatitis): CNTO 7160
Participants will receive Drug CNTO 7160 administered IV infusions (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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345928


Locations
Belgium
Antwerp, Belgium
Merksem, Belgium
Germany
Berlin, Germany
Hamburg, Germany
Hannover, Germany
Kiel, Germany
Mönchengladbach, Germany
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02345928     History of Changes
Other Study ID Numbers: CR105130
CNTO7160ASH1001 ( Other Identifier: Janssen Research & Development LLC. )
2014-000633-23 ( EudraCT Number )
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Safety
Efficacy
CNTO 7160
Healthy
Asthma
Atopic Dermatitis

Additional relevant MeSH terms:
Asthma
Dermatitis
Dermatitis, Atopic
Eczema
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous