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

Asthma Clinical Trial

Official title:

A 24-week, Multicenter, Randomized, Double-blind, Parallel-arm, Placebo-controlled Extension Study to Assess the Safety of CSJ117, When Added to Existing Standard of Care Asthma Therapy in Patients ≥18 Years of Age

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04946318
• Other study ID #: CCSJ117A12201E1
• Secondary ID: 2020-002341-42
• Status: Terminated
• Phase: Phase 2
• Start date: September 8, 2021
• Est. completion date: September 8, 2022

Study information

• Verified date: October 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 136
• Est. completion date: September 8, 2022
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CSJ117
CSJ117 (0.5 mg, 1mg, 2mg, 4 mg and 8 mg) capsules for inhalation once daily delivered via Concept1 inhalation device for 12 or 24 weeks.
• Placebo
Placebo inhaled once daily for 12 or 24 weeks. Delivered via Concept1 device.

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	Parana
Argentina	Novartis Investigative Site	Ranelagh, Partido De Berazate	Buenos Aires
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Belgium	Novartis Investigative Site	Erpent
Bulgaria	Novartis Investigative Site	Ruse
Bulgaria	Novartis Investigative Site	Stara Zagora
Canada	Novartis Investigative Site	Burlington	Ontario
Canada	Novartis Investigative Site	Etobicoke	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Czechia	Novartis Investigative Site	Lovosice
Czechia	Novartis Investigative Site	Teplice	CZE
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Witten
Hungary	Novartis Investigative Site	Balassagyarmat
Hungary	Novartis Investigative Site	Godollo
Hungary	Novartis Investigative Site	Komarom
Japan	Novartis Investigative Site	Chuo ku	Tokyo
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Kodaira	Tokyo
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka city	Osaka
Japan	Novartis Investigative Site	Setagaya-Ku	Tokyo
Japan	Novartis Investigative Site	Setagaya-ku	Tokyo
Japan	Novartis Investigative Site	Toshima	Tokyo
Japan	Novartis Investigative Site	Toshima ku	Tokyo
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Latvia	Novartis Investigative Site	Daugavpils
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga	LV
Philippines	Novartis Investigative Site	Iloilo
Philippines	Novartis Investigative Site	Iloilo City
Philippines	Novartis Investigative Site	Manila
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Poznan
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	St Petersburg
Slovakia	Novartis Investigative Site	Levice
United States	Novartis Investigative Site	Bakersfield	California
United States	Novartis Investigative Site	Boerne	Texas
United States	Novartis Investigative Site	Greenville	South Carolina
United States	Novartis Investigative Site	Huntington Beach	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Marietta	Georgia
United States	Novartis Investigative Site	McKinney	Texas
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	White Marsh	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Bulgaria,  Canada,  Czechia,  Germany,  Hungary,  Japan,  Latvia,  Philippines,  Poland,  Russian Federation,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs)	Number of treatment emergent AEs, AEs leading to study treatment discontinuation, SAEs and SAEs leading to study treatment discontinuation.; Treatment emergent AEs and SAEs will be counted from first day of treatment of the core study (CCSJ117A12201C) and until 30 days after last day of treatment in the extension study. For participants who will enter the extension study after the last follow-up visit (week 24) of the core study, AEs (if any) occurring from week 4 to week 12 of the drug free follow-up period will not be counted as treatment emergent AEs.	From start of treatment in the core study and until 30 days after end of treatment in the extension study. Up to 40 weeks.
Primary	Number of treatment emergent participant deaths and participant hospitalizations	Number of treatment emergent participant deaths and participant hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours).; Treatment emergent participant deaths and participant hospitalizations will be counted from first day of treatment of the core study (CCSJ117A12201C) and until 30 days after last day of treatment in the extension study. For participants who will enter the extension study after the last follow-up visit (week 24) of the core study, participant deaths and hospitalizations (if any) occurring from week 4 to week 12 of the drug free follow-up period will not be counted as treatment emergent participant deaths and hospitalizations.	From start of treatment in the core study and until 30 days after end of treatment in the extension study. Up to 40 weeks.
Secondary	Trough plasma concentration (Ctrough) at Steady State	Ctrough measured during the treatment period and the follow up period.	Participants entering directly after completion of study treatment of core study: Weeks 2, 4, 8, 12, 14, 16, 20, 24, 26, 28 and 36; Participants entering directly after completion of the core study Follow-up period: Weeks 2, 4, 8, 12, 14, 16 and 24.
Secondary	Terminal Elimination half-life (T1/2) at Steady State	Terminal Elimination half-life (T1/2) measured during the treatment period and the follow up period.	Participants entering directly after completion of study treatment of core study: Weeks 2, 4, 8, 12, 14, 16, 20, 24, 26, 28 and 36; Participants entering directly after completion of the core study Follow-up period: Weeks 2, 4, 8, 12, 14, 16 and 24.
Secondary	Change from baseline in Anti-drug immune response	The change from baseline in Anti-Drug Antibodies (ADA) titers during the treatment period and the follow up period.	Participants entering directly after completion of study treatment of core study: Weeks 2, 4, 8, 12, 14, 16, 20, 24, 26, 28 and 36; Participants entering directly after completion of the core study Follow-up period: Weeks 2, 4, 8, 12, 14, 16 and 24.
Secondary	Change from baseline in Fractional exhaled Nitric Oxide (FeNO) levels	The change from baseline (same as in the core study CSJ117A12201C) in the observed values in FeNO (including all scheduled post-baseline visits with FeNO data).	Participants entering directly after completion of study treatment of core study: Weeks 2, 4, 8, 12, 14, 16, 20, 24, 26, 28 and 36; Participants entering directly after completion of the core study Follow-up period: Weeks 2, 4, 8, 12, 14, 16 and 24.
Secondary	CSJ117 serum concentration	Measurement of the total CSJ117 serum concentration during the treatment period and the follow up period.	Participants entering directly after completion of study treatment of core study: Weeks 2, 4, 8, 12, 14, 16, 20, 24, 26, 28 and 36; Participants entering directly after completion of the core study Follow-up period: Weeks 2, 4, 8, 12, 14, 16 and 24.