NCT04946318 is a Phase 2 clinical trial of CSJ117 in Asthma, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT04946318?

NCT04946318 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT04946318?

Interventions in NCT04946318: CSJ117, Placebo.

Is NCT04946318 still recruiting?

NCT04946318 is currently terminated. Last updated 10 October 2022.

Last reviewed 2022-10-10 · How we verify

NCT04946318

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Last updated 10 October 2022

What this trial tests

Phase 2 trial testing CSJ117 in Asthma in 136 participants. Terminated before completion.

Timeline

8 September 2021

Primary endpoint
8 September 2022

8 September 2022

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	136
Start date	8 September 2021
Primary completion	8 September 2022
Estimated completion	8 September 2022
Sites	58 locations across Japan, Russia, Slovakia, Belgium, Germany, Hungary, Poland, Philippines

Drugs / interventions tested

CSJ117 — full drug profile →
Placebo

Conditions studied

Asthma — all drugs for Asthma →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 75, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Eosinophilic Asthma: Pathophysiology and Therapeutic Horizons.
Hussain M, Liu G. · · 2024 · cited 60× · PMID 38474348 · DOI 10.3390/cells13050384
Alternative Routes of Administration for Therapeutic Antibodies-State of the Art.
Pitiot A, Heuzé-Vourc'h N, Sécher T. · · 2022 · cited 45× · PMID 36134952 · DOI 10.3390/antib11030056
Human Lung Mast Cells: Therapeutic Implications in Asthma.
Poto R, Criscuolo G, Marone G, Brightling CE, et al · · 2022 · cited 26× · PMID 36430941 · DOI 10.3390/ijms232214466
Targeting alarmins in asthma: From bench to clinic.
Akenroye A, Boyce JA, Kita H. · · 2025 · cited 24× · PMID 39855362 · DOI 10.1016/j.jaci.2025.01.017
Targeting the Epithelium-Derived Innate Cytokines: From Bench to Bedside.
Ham J, Shin JW, Ko BC, Kim HY. · · 2022 · cited 21× · PMID 35291657 · DOI 10.4110/in.2022.22.e11
Advances in Biologic Therapies for Allergic Diseases: Current Trends, Emerging Agents, and Future Perspectives.
Alska E, Łaszczych D, Napiórkowska-Baran K, Szymczak B, et al · · 2025 · cited 13× · PMID 40004611 · DOI 10.3390/jcm14041079

Verify or expand the search:

Other trials of CSJ117

Trials testing the same drug.

NCT04882124 — Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD · Phase 2 · completed
NCT04410523 — Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma · Phase 2 · terminated
NCT03138811 — A Bronchoprovocation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CSJ117 in Adult · Phase 1 · completed

Other recruiting trials for Asthma

Currently open trials in the same condition.

NCT07525375 — A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared t · Phase 2 · recruiting
NCT07536256 — Community Connections Through Native Hawaiian Cultural Values to Strengthen Youth Resilience, Health, and Well-Being · NA · recruiting
NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice · recruiting
NCT07282886 — VENTURI (VENTilation Using Respiratory Imaging) · Phase 2 · recruiting
NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ · Phase 1 · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04946318 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 10 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04946318.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing