CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 118 enrolled
Drug / intervention
CJM112 +1 moredrug
Likely dose
CJM112 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03299686
NCT03299686Phase 2Completed

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

Novartis Pharmaceuticals·interventional·Posted Oct 3, 2017·Updated Oct 8, 2021

In Brief

A Phase 2 clinical trial evaluating CJM112 and Placebo to CJM112 for Asthma. Completed, enrolled 118 participants across 29 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Belgium, Denmark, France, Germany, Israel, Slovakia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 3, 2017
Enrollment StartNov 6, 2017
Primary CompletionApr 8, 2019
Study CompletionJul 8, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.7 years ago

Interventions

CJM112drug

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 CJM112other

Placebo to match CJM112 + standard of care treatment