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

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ClinicalTrials.gov Identifier: NCT03299686
Recruitment Status : Completed
First Posted : October 3, 2017
Results First Posted : August 6, 2020
Last Update Posted : August 12, 2020
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 was to determine if CJM112, an anti-IL-17A antibody, displayed 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

Detailed Description:

After an initial screening visit, run-in period and baseline assessments, the eligible subjects entered the treatment period and were randomized in a 3:2 ratio to one of the two treatment groups:

  • 300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12 (Day 85) + standard of care treatment.
  • Matching placebo + standard of care treatment. After completion of the last dose on Day 85 of treatment period, subjects returned for the final efficacy assessment on Day 92. Following the treatment period, all subjects entered a 13-week safety follow-up period, including the End of Study (EoS) visit on Day 176.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 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
Actual Primary Completion Date : April 8, 2019
Actual Study Completion Date : July 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: CJM112
Study treatment
Drug: CJM112
300 mg CJM112 (Study treatment) s.c. injection received per week for the first 4 weeks, followed by once every two weeks up to Week 12 (Day 85) + standard of care treatment.

Placebo Comparator: Placebo to CJM112
Placebo
Other: Placebo to CJM112
Placebo to match CJM112 + standard of care treatment




Primary Outcome Measures :
  1. Change From Baseline in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Baseline, Day 92 ]
    The primary efficacy analysis assessed the effect of CJM112 on the absolute change from baseline in trough FEV1 in Liters compared to placebo on Day 92. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment.


Secondary Outcome Measures :
  1. Change From Baseline in Forced Expiratory Volume 1 (FEV1) % of Predicted [ Time Frame: Baseline, Day 92 ]
    The secondary efficacy analyses assessed the effect of CJM112 on the absolute change from baseline in trough FEV1 in % of predicted compared to placebo on Day 92. Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1% of predicted is defined as FEV1% of the patient divided by the average FEV1% in the population for any person of similar age, sex and body composition. Pre-bronchodilator FEV1% of predicted was directly provided as part of the spirometry assessment.

  2. Change From Baseline in Asthma Control Questionnaire 6 (ACQ6) Score [ Time Frame: Baseline, Day 92 ]

    The ACQ-6 is a validated asthma assessment tool that consists of 6 self-assessment questions. Each item on the ACQ-6 has a possible score ranging from 0 to 6 and the total score is the mean of all responses. The seven-point response scale goes from 0 = 'totally controlled' to 6 = 'severely uncontrolled.

    Negative change from baseline values indicate improved asthma control.


  3. Change From Baseline in Asthma Control Questionnaire 7 (ACQ7) Score [ Time Frame: Baseline, Day 92 ]
    The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on airway calibre (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. A negative change from baseline indicates improvement in lung function.

  4. Percentage of Patients With at Least 0.5 Decrease in ACQ7 Score [ Time Frame: Baseline, Day 92 ]

    The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on airway calibre (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. A negative change from baseline indicates improvement in lung function.

    An ACQ7 responder is defined as a patient with a decrease in score of greater or equal to 0.5 when compared to baseline.


  5. Percentage of Patients With Adverse Events (AEs) Leading to Discontinuation of Study Treatment [ Time Frame: 85 days ]
    Number of patients with at least one adverse event leading to discontinuation of study treatment



Information from the National Library of Medicine

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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 use 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


Locations
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United States, California
Novartis Investigative Site
Fullerton, California, United States, 92835
Novartis Investigative Site
Riverside, California, United States, 92506
United States, Colorado
Novartis Investigative Site
Denver, Colorado, United States, 80206
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02115
United States, Missouri
Novartis Investigative Site
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Novartis Investigative Site
Raleigh, North Carolina, United States, 27607
United States, Oregon
Novartis Investigative Site
Medford, Oregon, United States, 97504
United States, South Carolina
Novartis Investigative Site
Spartanburg, South Carolina, United States, 29303
Argentina
Novartis Investigative Site
Mar del Plata, Buenos Aires, Argentina, 7600
Novartis Investigative Site
Santa Fe, Rosario, Argentina, S2000DBS
Belgium
Novartis Investigative Site
Jette, Brussel, Belgium, 1090
Novartis Investigative Site
Gent, Belgium, 9000
Novartis Investigative Site
Liege, Belgium, 4000
Denmark
Novartis Investigative Site
Aalborg, Denmark, DK 9000
Novartis Investigative Site
Copenhagen NV, Denmark, 2400
Novartis Investigative Site
Hvidovre, Denmark, 2650
Novartis Investigative Site
Odense C, Denmark, DK 5000
France
Novartis Investigative Site
Montpellier cedex 5, Herault, France, 34059
Novartis Investigative Site
Lyon Cedex 04, France, 69317
Germany
Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Berlin, Germany, 12159
Novartis Investigative Site
Grosshansdorf, Germany, 22927
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Wiesbaden, Germany, 65187
Israel
Novartis Investigative Site
Jerusalem, Israel, 91120
Novartis Investigative Site
Jerusalem, Israel
Novartis Investigative Site
Rehovot, Israel, 76100
Slovakia
Novartis Investigative Site
Levice, Slovakia, 034 01
Novartis Investigative Site
Spisska Nova Ves, Slovakia, 052 01
Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] August 14, 2019
Study Protocol  [PDF] May 15, 2018

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03299686    
Other Study ID Numbers: CCJM112X2204
First Posted: October 3, 2017    Key Record Dates
Results First Posted: August 6, 2020
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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


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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, allergy triggered asthma, reactive asthma, asthma attack, difficulty breathing
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases