Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Assess the Efficacy and Safety of CJM112 in Patients With Inadequately Controlled Severe Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03299686
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
An unmet medical need exists for patients with moderate and severe asthma who continue to demonstrate symptoms despite being on standard of care medications, and are not eligible for other biologic therapies developed or in development for T2-high(allergic/eosinophilic) asthma. The purpose of this study is to determine if CJM112, an anti-IL-17A antibody, displays the clinical efficacy and safety profile to support further development in patients with inadequately controlled moderate to severe asthma with low IgE and low circulating eosinophil levels.

Condition or disease Intervention/treatment Phase
Asthma Drug: CJM112 Other: Placebo to CJM112 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Subject- and Investigator-blinded, Placebo Controlled, Multi-center, Multiple Dose Study to Assess the Efficacy and Safety of CJM112 in Patients With Inadequately Controlled Moderate to Severe Asthma
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : July 5, 2019
Estimated Study Completion Date : July 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: CJM112
Study treatment
Drug: CJM112
Study treatment

Placebo Comparator: Placebo to CJM112
Placebo
Other: Placebo to CJM112
Placebo to match CJM112




Primary Outcome Measures :
  1. Change from baseline Forced Expiratory Volume 1 (FEV1) [ Time Frame: Baseline, Day 92 ]
    Change from baseline FEV1 in mL


Secondary Outcome Measures :
  1. Change from baseline Forced Expiratory Volume 1 (FEV1) % of predicted [ Time Frame: Baseline, Day 92 ]
    Change from baseline FEV1 % of predicted

  2. Change from baseline in Asthma Control Questionnaire (ACQ) score [ Time Frame: Baseline, Day 92 ]
    Change from baseline in ACQ score

  3. % of patients with ≥ 0.5 decrease in ACQ score [ Time Frame: Baseline, Day 92 ]
    % of patients with ≥ 0.5 decrease in Asthma Control Questionnaire (ACQ) score

  4. Adverse Events [ Time Frame: Day 176 (End of Study) ]
    Study treatment discontinuations and adverse events



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a physician-diagnosed history of moderate to severe asthma for a period of at least one year prior to screening.
  2. Patients on a stable therapy regimen of asthma for at least 3 months prior to screening with at least medium dose inhaled glucocorticoid and at least one additional asthma controller medication (such as inhaled long-acting bronchodilator, leukotriene antagonist, theophylline, stable low dose glucocorticoid, etc).
  3. Acceptable and reproducible spirometry with FEV1 ≥ 40 and ≤ 90% of predicted at screening and baseline (re-testing is allowed once).
  4. ACQ score ≥ 1.5 at screening and baseline (re-testing is allowed once).
  5. Total serum IgE < 150 IU/mL
  6. Peripheral blood eosinophils <300/μL

Exclusion Criteria:

  1. Previous use of biologics or other concomitant medications within the time periods specified in the SOM/protocol.
  2. History of ongoing, chronic, or recurrent moderate or severe infectious disease.
  3. Patients who have smoked or inhaled nicotine or tobacco products within the 6 month period prior to Visit 1 or who have a smoking history of greater than 10 pack years.
  4. Patients who have had an asthma attack/exacerbation requiring systemic corticosteroids for at least 3 continuous days within 4 weeks prior to screening.
  5. Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Visit 1 or during the screening period.
  6. Women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for 13 weeks after stopping of investigational drug.

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): NCT03299686


Contacts
Layout table for location contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

  Show 35 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03299686     History of Changes
Other Study ID Numbers: CCJM112X2204
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Asthma, allergic, eosinophilic, non-T2 high

Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases