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Clinical trial

A 12-week, Multicenter, Randomized, Double-blind, Parallel-arm, Placebo-controlled Study to Assess the Efficacy and Safety of CSJ117, When Added to Existing Asthma Therapy in Patients ≥ 18 Years of Age With Severe Uncontrolled Asthma.

ID
Name
CCSJ117A12201C
Description
The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect to change from baseline in FEV1 at the end of 12 weeks of treatment.
Trial arms
Trial start
2020-09-09
Estimated PCD
2022-07-12
Trial end
2022-09-06
Status
Terminated
Phase
Early phase I
Treatment
CSJ117
CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device. CSJ117 = inhaled monoclonal antibody fragment
Arms:
CSJ117 0.5mg, CSJ117 1mg, CSJ117 2mg, CSJ117 4mg, CSJ117 8mg
Placebo
Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period. Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.
Arms:
CSJ117 0.5mg, CSJ117 1mg, CSJ117 2mg, CSJ117 4mg, CSJ117 8mg, Placebo
Size
335
Primary endpoint
Average Change From Baseline in Pre-dose FEV1 at Week 8 and Week 12
Baseline, Weeks 8-12
Eligibility criteria
Inclusion Criteria: * Diagnosed asthma * Male and female patients aged ≥18 and ≤75 years * Patients who have been treated with medium or high dose ICS plus LABA with up to 2 additional controllers * Morning pre-BD FEV1 value of ≥ 40% and ≤ 85% of the predicted normal * A positive reversibility test * ACQ-5 score of ≥ 1.5 at screening and end of run-in visits. Exclusion Criteria: * Patients who have a cigarette smoking history of greater than 10 pack years or current smokers * Pregnant or nursing (lactating) women * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using specified methods of contraception during dosing of study drug and until 12 weeks after last study drug treatment * Patients with a history of immunodeficiency disease or hepatitis B, untreated and not cured hepatitis C or HIV.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 335, 'type': 'ACTUAL'}}
Updated at
2023-08-07

1 organization

2 products

1 indication

Organization
Novartis Pharmaceuticals
Product
CSJ117
Indication
Asthma
Product
Placebo