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

NCT04946318 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: CCSJ117A12201E12020-002341-42
• Study Type: interventional
• Target: 136
• Locations: 14 countries
• Sites: 58

Brief 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).

Conditions

Asthma

Keywords

CSJ, GINA 2019, Safety

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (5)

• Trough plasma concentration (Ctrough) at Steady State

  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

  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

  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

  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

  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.

Study Arms (6)

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

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

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

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.

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.

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.

Drug: CSJ117

Interventions

CSJ117 DRUG

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.

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

Placebo DRUG

Placebo inhaled once daily for 12 or 24 weeks. Delivered via Concept1 device.

24-week Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (58)

Novartis Investigative Site

Bakersfield, California, 93301, United States

Location

Novartis Investigative Site

Huntington Beach, California, 92647, United States

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Novartis Investigative Site

Los Angeles, California, 90017, United States

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Novartis Investigative Site

Los Angeles, California, 90025, United States

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Novartis Investigative Site

Marietta, Georgia, 30060, United States

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Novartis Investigative Site

White Marsh, Maryland, 21162, United States

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Novartis Investigative Site

Oklahoma City, Oklahoma, 73120, United States

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Novartis Investigative Site

Greenville, South Carolina, 29607, United States

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Novartis Investigative Site

Boerne, Texas, 78006, United States

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Novartis Investigative Site

McKinney, Texas, 75069, United States

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Novartis Investigative Site

CABA, Buenos Aires, C1122AAK, Argentina

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Novartis Investigative Site

Ranelagh, Partido de Berazate, Buenos Aires, 1884, Argentina

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Novartis Investigative Site

Rosario, Santa Fe Province, S2000JKR, Argentina

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Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Novartis Investigative Site

Mendoza, 5500, Argentina

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Novartis Investigative Site

Paraná, 3100, Argentina

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Novartis Investigative Site

Erpent, 5100, Belgium

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Novartis Investigative Site

Rousse, 7002, Bulgaria

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Novartis Investigative Site

Stara Zagora, 6000, Bulgaria

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Novartis Investigative Site

Burlington, Ontario, L7N 3V2, Canada

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Novartis Investigative Site

Etobicoke, Ontario, M9V 4B4, Canada

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Novartis Investigative Site

Montreal, Quebec, H2V 2K1, Canada

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Novartis Investigative Site

Teplice, CZE, 415 01, Czechia

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Novartis Investigative Site

Lovosice, 41002, Czechia

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Novartis Investigative Site

Berlin, 10119, Germany

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Novartis Investigative Site

Berlin, 10717, Germany

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Novartis Investigative Site

Berlin, 10969, Germany

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Novartis Investigative Site

Berlin, 12159, Germany

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Novartis Investigative Site

Frankfurt, 60596, Germany

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Novartis Investigative Site

Leipzig, D-04299, Germany

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Novartis Investigative Site

Leipzig, D-04347, Germany

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Novartis Investigative Site

Witten, 58452, Germany

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Novartis Investigative Site

Balassagyarmat, 2660, Hungary

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Novartis Investigative Site

Gödöllő, 2100, Hungary

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Novartis Investigative Site

Komárom, 2900, Hungary

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Novartis Investigative Site

Yokohama, Kanagawa, 223-0059, Japan

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Novartis Investigative Site

Osaka, Osaka, 530 0001, Japan

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Novartis Investigative Site

Chuo Ku, Tokyo, 104-0031, Japan

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Novartis Investigative Site

Chuo-ku, Tokyo, 103-0003, Japan

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Novartis Investigative Site

Chuo-ku, Tokyo, 103-0028, Japan

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Novartis Investigative Site

Kodaira, Tokyo, 187-0024, Japan

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Novartis Investigative Site

Setagaya-Ku, Tokyo, 157-0072, Japan

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Novartis Investigative Site

Setagaya-ku, Tokyo, 158-0097, Japan

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Novartis Investigative Site

Toshima City, Tokyo, 170-0003, Japan

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Novartis Investigative Site

Toshima Ku, Tokyo, 170 0003, Japan

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Novartis Investigative Site

Osaka, 531-0073, Japan

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Novartis Investigative Site

Osaka, 551-0032, Japan

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Novartis Investigative Site

Riga, LV, 1038, Latvia

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Novartis Investigative Site

Daugavpils, LV-5417, Latvia

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Novartis Investigative Site

Riga, LV 1002, Latvia

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Novartis Investigative Site

Iloilo City, 5000, Philippines

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Novartis Investigative Site

Manila, 1003, Philippines

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Novartis Investigative Site

Krakow, 30033, Poland

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Novartis Investigative Site

Poznan, 60-693, Poland

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Novartis Investigative Site

Poznan, 60-823, Poland

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Novartis Investigative Site

Saint Petersburg, 194354, Russia

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Novartis Investigative Site

Saratov, 410012, Russia

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Novartis Investigative Site

Levice, 93401, Slovakia

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: June 30, 2021
• Study Start: September 8, 2021
• Primary Completion: September 8, 2022
• Study Completion: September 8, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

SL (1); BE (1); US (10); AR (6); CZ (2); BU (2); HU (3); LA (3); PH (2); CA (3); JP (12); DE (8); PL (3); RU (2)