Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma

Novartis

Status and phase: Terminated; Phase 2

Conditions: Asthma

Treatments: Drug: CSJ117; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04946318

2020-002341-42 (EudraCT Number)

CCSJ117A12201E1

Details and patient eligibility

About

The purpose of this study is to provide safety and tolerability, pharmacokinetics and immunogenicity data for multiple CSJ117 doses inhaled once daily compared with placebo, in adult asthma participants treated with medium or high dose ICS plus LABA alone or with additional asthma controllers (additional controllers allowed: LTRA, LAMA, Theophylline and its derivatives), who have completed the prior phase llb study CCSJ117A12201C (NCT04410523).

Full description

This is a 12/24-week Phase llb, multicenter, multi-national, double-blind, randomized, parallel-arm, placebo-controlled extension study to evaluate the safety and tolerability, pharmacokinetics and immunogenicity of 5 dose levels of CSJ117 in adult asthma participants treated with medium or high dose ICS plus LABA alone or with additional asthma controllers (allowed: LTRA, LAMA, theophylline or its derivatives), who have completed the prior core phase llb study CCSJ117A12201C (NCT04410523). The study will include the following three parts:

A Screening period of up to 3 days to assess eligibility.

A Treatment period of 12 or 24 weeks. There are two scenarios on when a participant can enroll into the extension study depending on when the study site is activated for the extension study CCSJ117A12201E1:

• A 24 week treatment period: Participants on each of the five treatment arms (CSJ117 0.5 to 8 mg) or placebo of the core study CCSJ117A12201C, who will enter the extension study after the last Treatment period visit (week 12) of the core study, will be randomized in a 1:1 ratio to continue on their previously assigned CSJ117 dose or placebo from CCSJ117A12201C for 24 weeks, or to first go through a 12-week "washout period" receiving placebo (for the blinding purpose) and then restart on their previously assigned CSJ117 dose or placebo from CCSJ117A12201C for 12 weeks.
• A 12 week treatment period: Participants on each of the five treatment arms (CSJ117 0.5 to 8 mg) or placebo of the core study CCSJ117A12201C, who will enter the extension study after the last Follow-up visit (week 24) of the core study, will restart on their previously assigned CSJ117 dose or placebo from CCSJ117A12201C for 12 weeks.

A Follow-up period of 12 weeks, study drug free, following the last dose of study drug.

Enrollment: 136 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All participants must have been treated with a fixed dose combination of fluticasone propionate/salmeterol in one of two doses in stable dose alone or with additional controllers at label approved dosage (allowed only: LTRA, LAMA, Theophylline or its derivatives).
• Participants completing the Treatment period and Follow-up period of study CSJ117A12201C and continuing with study CCSJ117A12201E1 must have completed the Treatment period of CSJ117A12201C (i.e. did not discontinue blinded study treatment prematurely) and Follow-up period of study CSJ117A12201C.

Exclusion criteria

• Participants who were enrolled into prior study CSJ117A12201C and developed a significant and/or permanent health condition during the prior study.
• Participants who experienced a serious and drug-related AE in the prior study CSJ117A12201C.
• Participants receiving any prohibited medications.
• Participants with a history or current diagnosis of ECG abnormalities.
• Pregnant or nursing (lactating) women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

136 participants in 6 patient groups, including a placebo group

24-week Placebo

Placebo Comparator group

Description:

Participants who will enter the extension study after the last treatment visit (week 12) of the core study and will be treated with Placebo inhaled once daily for 24 weeks

Treatment:

Drug: Placebo

Drug: CSJ117

12-week wash out + 12-week Placebo

Placebo Comparator group

Description:

Participants who will enter the extension study after the last treatment visit (week 12) of the core study and will be treated with Placebo inhaled once daily for 12 weeks "washout period" and Placebo inhaled once daily for 12 weeks

Treatment:

Drug: CSJ117

12-week Placebo

Placebo Comparator group

Description:

Participants who will enter the extension study after the last follow-up visit (week 24) of the core study will be treated with Placebo inhaled once daily for 12 weeks

Treatment:

Drug: CSJ117

24-week CSJ117

Experimental group

Description:

Participants who will enter the extension study after the last treatment visit (week 12) of the core study and will be treated once daily for 24 weeks with the same dose of CSJ117 they received in the core study. CSJ117 (0.5 mg, 1 mg, 2 mg, 4 mg and 8 mg) inhaled once daily for 24 weeks.

Treatment:

Drug: CSJ117

12-week wash out + 12-week CSJ117

Experimental group

Description:

Participants who will enter the extension study after the last treatment visit (week 12) of the core study and will be treated with Placebo inhaled once daily for 12 weeks "washout period" and then they will be treated once daily for 12 weeks with the same dose of CSJ117 they received in the core study. CSJ117 (0.5 mg, 1 mg, 2 mg, 4 mg and 8 mg) inhaled once daily for 12 weeks.

Treatment:

Drug: CSJ117

12-week CSJ117

Experimental group

Description:

Participants who will enter the extension study after the last follow-up visit (week 24) of the core study will be treated with once daily for 12 weeks with the same dose of CSJ117 they received in the core study. CSJ117 (0.5 mg, 1 mg, 2 mg, 4 mg and 8 mg) inhaled once daily for 24 weeks.

Treatment:

Drug: CSJ117