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NCT03627052
A Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis
Phase 2 trial testing Itacitinib in Moderate to Severe Ulcerative Colitis. Withdrawn.
13 November 2019
Quick facts
| Lead sponsor | Incyte Corporation |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Start date | 20 September 2018 |
| Primary completion | 13 November 2019 |
| Estimated completion | 13 November 2019 |
Drugs / interventions tested
- Itacitinib — full drug profile →
- Placebo
Conditions studied
- Moderate to Severe Ulcerative Colitis — all drugs for Moderate to Severe Ulcerative Colitis →
Sponsor
Incyte Corporation — full company profile →
Who can join
Adults 18 to 74, any sex, with Moderate to Severe Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the efficacy and safety of itacitinib in participants with moderate to severe ulcerative colitis (UC).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Efficacy, Safety and Future Perspectives of JAK Inhibitors in the IBD Treatment.
Dudek P, Fabisiak A, Zatorski H, Malecka-Wojciesko E, et al · · 2021 · cited 33× · PMID 34884361 · DOI 10.3390/jcm10235660 -
Efficacy of JAK inhibitors in Ulcerative Colitis.
Ferrante M, Sabino J. · · 2020 · cited 25× · PMID 31879750 · DOI 10.1093/ecco-jcc/jjz202 -
Novel Therapeutic Options for People with Ulcerative Colitis: An Update on Recent Developments with Janus Kinase (JAK) Inhibitors.
Troncone E, Marafini I, Del Vecchio Blanco G, Di Grazia A, et al · · 2020 · cited 21× · PMID 32440190 · DOI 10.2147/ceg.s208020 -
Anti-IL23/12 agents and JAK inhibitors for inflammatory bowel disease.
Tian Z, Zhao Q, Teng X. · · 2024 · cited 13× · PMID 39086483 · DOI 10.3389/fimmu.2024.1393463 -
Oral Janus kinase inhibitors for maintenance of remission in ulcerative colitis.
Davies SC, Hussein IM, Nguyen TM, Parker CE, et al · · 2020 · cited 9× · PMID 31984480 · DOI 10.1002/14651858.cd012381.pub2 -
Advancing therapeutic frontiers: a pipeline of novel drugs for UC management.
Bertin L, Massano A, Redavid C, Scarpa M, et al · · 2026 · PMID 41822012 · DOI 10.3389/fgstr.2026.1747118
Verify or expand the search:
- PubMed search for NCT03627052
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Itacitinib
Trials testing the same drug.
- NCT05660421 — Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors · Phase 2 · withdrawn
- NCT05364762 — Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergo · Phase 2 · active not recruiting
- NCT05063110 — Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB · Phase 2 · completed
- NCT04859946 — Itacitinib for the Prevention of Graft Versus Host Disease · Phase 2 · active not recruiting
- NCT04239989 — Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant · Phase 1 · terminated
Other recruiting trials for Moderate to Severe Ulcerative Colitis
Currently open trials in the same condition.
- NCT06693908 — A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Co · Phase 1, PHASE2 · recruiting
- NCT05486104 — Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis · Phase 2 · active not recruiting
Other Incyte Corporation trials
Trials by the same sponsor.
- NCT07124078 — A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Di · Phase 2 · recruiting
- NCT07441694 — Study of INCA036978 in Participants With Myeloproliferative Neoplasms · Phase 1 · recruiting
- NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
- NCT07448155 — A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous A · Phase 1 · active not recruiting
- NCT07284849 — A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 i · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03627052 (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 Incyte Corporation
- Last refreshed: 6 December 2019
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/NCT03627052.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing