Study of safety of CSJ117 in participants with moderate to severe uncontrolled asthma

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 who completed study CCSJ117A12201C

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002341-42-HU

Enrollment

375

Registered

2021-09-01

Start date

2021-10-12

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Code: CSJ117 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: not yet defined Current Sponsor code: CSJ117 Other descriptive name: CSJ117 Concentration unit: mg millig

Eligibility

Sex/Gender

All

Inclusion criteria

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 - Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 335 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

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. - Other protocol-defined exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate safety and tolerability of five doses of CSJ117 inhaled once daily compared to placebo in participants with moderate to severe asthma receiving SoC asthma therapy;Secondary Objective: - To characterize the systemic pharmacokinetic (PK) profile of five doses of CSJ117 inhaled once daily. - To characterize the immunogenicity of five doses of CSJ117 inhaled once daily. - To evaluate the Fractional exhaled Nitric Oxide (FeNO) levels of five doses of CSJ117 inhaled once daily compared to placebo.;Primary end point(s): - Overall and exposure-adjusted rates of treatment emergent AEs, AEs leading to study treatment discontinuation, SAEs, and SAEs leading to study treatment discontinuation; - Rate 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).;Timepoint(s) of evaluation of this end point: From start of treatment in the core study and until 30 days after end of treatment in the extension study. Up to 40 weeks.	—

Measure

Time frame

Main Objective: To evaluate safety and tolerability of five doses of CSJ117 inhaled once daily compared to placebo in participants with moderate to severe asthma receiving SoC asthma therapy;Secondary Objective: - To characterize the systemic pharmacokinetic (PK) profile of five doses of CSJ117 inhaled once daily. - To characterize the immunogenicity of five doses of CSJ117 inhaled once daily. - To evaluate the Fractional exhaled Nitric Oxide (FeNO) levels of five doses of CSJ117 inhaled once daily compared to placebo.;Primary end point(s): - Overall and exposure-adjusted rates of treatment emergent AEs, AEs leading to study treatment discontinuation, SAEs, and SAEs leading to study treatment discontinuation; - Rate 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).;Timepoint(s) of evaluation of this end point: From start of treatment in the core study and until 30 days after end of treatment in the extension study. Up to 40 weeks.

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Secondary

Measure	Time frame
Secondary end point(s): - Measurement of the total CSJ117 serum concentration during the Treatment period and Follow up period and calculation of PK parameters (e.g., Ctrough, T½). - Measurement of the incidence of Anti-Drug Antibodies (ADA) and measurement of ADA titers at baseline* and during the Treatment period and Follow up period. - Change from baseline* in FeNO levels.;Timepoint(s) of evaluation of this end point: 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.	—

Measure

Time frame

Secondary end point(s): - Measurement of the total CSJ117 serum concentration during the Treatment period and Follow up period and calculation of PK parameters (e.g., Ctrough, T½). - Measurement of the incidence of Anti-Drug Antibodies (ADA) and measurement of ADA titers at baseline* and during the Treatment period and Follow up period. - Change from baseline* in FeNO levels.;Timepoint(s) of evaluation of this end point: 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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Countries

Argentina, Belgium, Bulgaria, Canada, Czechia, Czech Republic, France, Germany, Guatemala, Hungary, Italy, Japan, Korea, Republic of, Latvia, Philippines, Poland, Russian Federation, Slovakia, United States

Contacts

Public ContactPublic Information Desk

Novartis Hungary Kft.

infoph.hungary@novartis.com00 36 1 457-6500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026