Study to Assess the Efficacy and Safety of CJM112 in Patients With Inadequately Controlled Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: CJM112; Placebo to CJM112
Intervention description: 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 to match CJM112 + standard of care treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma, allergic, eosinophilic, non-T2 high, allergy triggered asthma, reactive asthma, asthma attack, difficulty breathing

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.
    

Eligibility 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.