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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04946318
Other study ID # CCSJ117A12201E1
Secondary ID 2020-002341-42
Status Terminated
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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