A Study of the Safety and Effectiveness of JNJ-39758979 in the Treatment of Adults With Persistent Asthma

NCT ID: NCT00946569

Last Updated: 2014-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-09-30

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of once daily oral administration of JNJ-39758979 in the treatment of adults (18 to 65 years of age) with persistent asthma.

Detailed Description

This is a multicenter, double-blind (neither physician nor participants knows the treatment that the participant receives), randomized (study medication is assigned by chance), placebo-controlled (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study), parallel group (each group of participants will be treated at the same time), exploratory study (JNJ-39758979 is introduced in participants with asthma for the first time). This study consists of 4 phases: screening phase (4 weeks prior to the start of the run-in period), placebo run-in phase (2 weeks prior to the start of treatment phase), double-blind treatment phase (12 weeks), and posttreatment phase (5 weeks). Approximately 100 participants will be randomly allocated to 1 of 2 treatment groups: Treatment A (participants will receive JNJ-39758979 once daily) and treatment B (participants will receive placebo once daily). Safety will be evaluated by assessment of adverse events, clinical laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram. Total study duration for each participant will be approximately 23 weeks.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment A (JNJ39758979)

Participants will receive JNJ39758979 300mg once daily for 12 weeks.

Group Type: EXPERIMENTAL

JNJ39758979

Intervention Type: DRUG

Participants will receive capsule-shaped tablet of JNJ39758979 300mg once daily orally for 12 weeks.

Treatment B (Placebo)

Participants will receive matching placebo once daily for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive matching placebo once daily orally for 12 weeks.

Interventions

JNJ39758979

Participants will receive capsule-shaped tablet of JNJ39758979 300mg once daily orally for 12 weeks.

Intervention Type: DRUG

Placebo

Participants will receive matching placebo once daily orally for 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of asthma for at least 6 months
• Short-acting beta-agonist use greater than or equal to 5 times in the 2 weeks prior to screening
• Healthy on the basis of physical examination, medical history, vital signs, and 12 lead ECG performed at screening
• Having adequate laboratory values
• No history of/active or latent tuberculosis
• Agree to use protocol defined contraceptive methods

Exclusion Criteria

• History of life-threatening asthma attack requiring hospitalization for asthma within 5 years of screening, or emergency department treatment of asthma within the last month
• Moderate or severe renal insufficiency
• Cigarette smoking within the last year - Viral or bacterial vaccination within the last month (eg, FluMist)
• Human Immunodeficiency Virus (HIV) or Hepatitis B or C positive

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Scottsdale, Arizona, United States

Cypress, California, United States

Los Angeles, California, United States

San Diego, California, United States

Normal, Illinois, United States

North Dartmouth, Massachusetts, United States

Papillion, Nebraska, United States

Cincinnati, Ohio, United States

Oklahoma City, Oklahoma, United States

Medford, Oregon, United States

Portland, Oregon, United States

Dallas, Texas, United States

Waco, Texas, United States

Madison, Wisconsin, United States

Kelowna, British Columbia, Canada

Niagara Falls, Ontario, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Québec, Quebec, Canada

Chennai, , India

Mumbai, , India

Mysore, , India

Pune, , India

Bucharest, , Romania

Countries

United States; Canada; India; Romania

References

Kollmeier AP, Greenspan A, Xu XL, Silkoff PE, Barnathan ES, Loza MJ, Jiang J, Zhou B, Chen B, Thurmond RL. Phase 2a, randomized, double-blind, placebo-controlled, multicentre, parallel-group study of an H4 R-antagonist (JNJ-39758979) in adults with uncontrolled asthma. Clin Exp Allergy. 2018 Aug;48(8):957-969. doi: 10.1111/cea.13154. Epub 2018 Jun 6.

Reference Type: DERIVED

PMID: 29682796 (View on PubMed)

Other Identifiers

39758979ASH2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR016423

Identifier Type: -

Identifier Source: org_study_id