AsthmaPhase 2NCT04946318
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
A Phase 2 study testing CSJ117 in people with Asthma, run by Novartis Pharmaceuticals at 58 sites in 14 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- CSJ117
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 58 sitesin 14 countries
- Study dates
- 8 Sep 2021to 8 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
58 sites in 14 countries.
58 sites in 14 countries
Japan12 sites
Novartis Investigative Site
Chuo Ku, Tokyo, 104-0031
Novartis Investigative Site
Chuo-ku, Tokyo, 103-0003
Novartis Investigative Site
Chuo-ku, Tokyo, 103-0028
Novartis Investigative Site
Kodaira, Tokyo, 187-0024
Novartis Investigative Site
Osaka, Osaka, 530 0001
Novartis Investigative Site
Osaka, 531-0073
Novartis Investigative Site
Osaka, 551-0032
Novartis Investigative Site
Setagaya-ku, Tokyo, 158-0097
Novartis Investigative Site
Setagaya-Ku, Tokyo, 157-0072
Novartis Investigative Site
Toshima City, Tokyo, 170-0003
Novartis Investigative Site
Toshima Ku, Tokyo, 170 0003
Novartis Investigative Site
Yokohama, Kanagawa, 223-0059
United States10 sites
Novartis Investigative Site
Bakersfield, California, 93301
Novartis Investigative Site
Boerne, Texas, 78006
Novartis Investigative Site
Greenville, South Carolina, 29607
Novartis Investigative Site
Huntington Beach, California, 92647
Novartis Investigative Site
Los Angeles, California, 90017
Novartis Investigative Site
Los Angeles, California, 90025
Novartis Investigative Site
Marietta, Georgia, 30060
Novartis Investigative Site
McKinney, Texas, 75069
Novartis Investigative Site
Oklahoma City, Oklahoma, 73120
Novartis Investigative Site
White Marsh, Maryland, 21162
Germany8 sites
Novartis Investigative Site
Berlin, 10119
Novartis Investigative Site
Berlin, 10717
Novartis Investigative Site
Berlin, 10969
Novartis Investigative Site
Berlin, 12159
Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Leipzig, D-04299
Novartis Investigative Site
Leipzig, D-04347
Novartis Investigative Site
Witten, 58452
Argentina6 sites
Novartis Investigative Site
CABA, Buenos Aires, C1122AAK
Novartis Investigative Site
Mendoza, 5500
Novartis Investigative Site
Paraná, 3100
Novartis Investigative Site
Ranelagh, Partido de Berazate, Buenos Aires, 1884
Novartis Investigative Site
Rosario, Santa Fe Province, S2000JKR
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, 4000
Canada3 sites
Novartis Investigative Site
Burlington, Ontario, L7N 3V2
Novartis Investigative Site
Etobicoke, Ontario, M9V 4B4
Novartis Investigative Site
Montreal, Quebec, H2V 2K1
Hungary3 sites
Novartis Investigative Site
Balassagyarmat, 2660
Novartis Investigative Site
Gödöllő, 2100
Novartis Investigative Site
Komárom, 2900
Latvia3 sites
Novartis Investigative Site
Daugavpils, LV-5417
Novartis Investigative Site
Riga, LV, 1038
Novartis Investigative Site
Riga, LV 1002
Poland3 sites
Novartis Investigative Site
Krakow, 30033
Novartis Investigative Site
Poznan, 60-693
Novartis Investigative Site
Poznan, 60-823
Bulgaria2 sites
Novartis Investigative Site
Rousse, 7002
Novartis Investigative Site
Stara Zagora, 6000
Czechia2 sites
Novartis Investigative Site
Lovosice, 41002
Novartis Investigative Site
Teplice, CZE, 415 01
Philippines2 sites
Novartis Investigative Site
Iloilo City, 5000
Novartis Investigative Site
Manila, 1003
Russia2 sites
Novartis Investigative Site
Saint Petersburg, 194354
Novartis Investigative Site
Saratov, 410012
About this study
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
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).
Read the detailed 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.
- Conditions
- Asthma
- Being tested
- CSJ117, Placebo
- Keywords
- CSJ, GINA 2019, Safety
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSJ117Drug
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.
PlaceboDrug
Placebo inhaled once daily for 12 or 24 weeks. Delivered via Concept1 device.
| Study group | Role | What they receive |
|---|---|---|
| 24-week Placebo | Placebo comparator | 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 Receives: Drug: CSJ117; Drug: Placebo |
| 12-week wash out + 12-week Placebo | Placebo comparator | 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 Receives: Drug: CSJ117 |
| 12-week Placebo | Placebo comparator | 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 Receives: Drug: CSJ117 |
| 24-week CSJ117 | Experimental | 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. Receives: Drug: CSJ117 |
| 12-week wash out + 12-week CSJ117 | Experimental | 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. Receives: Drug: CSJ117 |
| 12-week CSJ117 | Experimental | 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. Receives: Drug: CSJ117 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of treatment in the core study and until 30 days after end of treatment in the extension study. Up to 40 weeks.
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.
Measured: 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 outcomes (5)
Trough plasma concentration (Ctrough) at Steady State
Ctrough measured during the treatment period and the follow up period.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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).
Measured: 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.
CSJ117 serum concentration
Measurement of the total CSJ117 serum concentration during the treatment period and the follow up period.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start8 Sep 2021
- Primary completion8 Sep 2022
- Study completion8 Sep 2022
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946318
- Sponsor's protocol ID
- CCSJ117A12201E1
- Other IDs
- 2020-002341-42
- Status last verified
- Oct 2022
- First submitted
- 23 Jun 2021
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04946318
- Acronym / sponsor ID
- CCSJ117A12201E1
- Conditions
- Asthma
- Keywords
- CSJ, GINA 2019, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 24-week Placebo | Placebo comparator | Drug: CSJ117, Drug: PlaceboParticipants 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 |
| 12-week wash out + 12-week Placebo | Placebo comparator | Drug: CSJ117Participants 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 |
| 12-week Placebo | Placebo comparator | Drug: CSJ117Participants 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 |
| 24-week CSJ117 | Experimental | Drug: CSJ117Participants 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. |
| 12-week wash out + 12-week CSJ117 | Experimental | Drug: CSJ117Participants 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. |
| 12-week CSJ117 | Experimental | Drug: CSJ117Participants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSJ117CSJ117 (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. | Drug | 12-week CSJ117, 12-week Placebo, 12-week wash out + 12-week CSJ117, 12-week wash out + 12-week Placebo, 24-week CSJ117, 24-week Placebo |
| PlaceboPlacebo inhaled once daily for 12 or 24 weeks. Delivered via Concept1 device. | Drug | 24-week Placebo |
Primary outcome
Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs)
Time frame: From start of treatment in the core study and until 30 days after end of treatment in the extension study. Up to 40 weeks.
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.
Number of treatment emergent participant deaths and participant hospitalizations
Time frame: From start of treatment in the core study and until 30 days after end of treatment in the extension study. Up to 40 weeks.
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.
5 secondary outcomes
Trough plasma concentration (Ctrough) at Steady State
Time frame: 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.
Terminal Elimination half-life (T1/2) at Steady State
Time frame: 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.
Change from baseline in Anti-drug immune response
Time frame: 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.
Change from baseline in Fractional exhaled Nitric Oxide (FeNO) levels
Time frame: 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.
CSJ117 serum concentration
Time frame: 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.
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
58 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CSJ117 in people with Asthma, run by Novartis Pharmaceuticals at 58 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in Japan, United States, Germany, Argentina, Canada and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) (time frame: From start of treatment in the core study and until 30 days after end of treatment in the extension study. Up to 40 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.