- Featured
A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302)
For more information, please contact Incyte Corporation at 1.855.463.3463 or visit **[www.incyteclinicaltrials.com](https://www.incyteclinicaltrials.com/)**
Phase
3Span
Sponsor
Shinjuku-Ku, Shinjuku
Recruiting
- Featured
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
* Interventional Study * Estimated Enrollment:170 participants * Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations. * This study consists of 3 cohorts that will have study drug administered in parallel, Cohort A, Cohort B, and Cohort C. * There is no difference in the treatment regimen between the cohorts.
Phase
2Span
Sponsor
Shinjuku-Ku, Shinjuku
Recruiting
- Featured
Shinjuku-Ku, Shinjuku
Recruiting
- Featured
Study to evaluate HZN-825 in patients with Diffuse Cutaneous Systemic Sclerosis (dcSSc)
This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial for HZN-825, a selective antagonist of lysophosphatidic acid receptor-1 (LPAR1). Participants will be screened within 4 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks. Participants will take their first dose of trial drug at the clinic and will return to the clinic for trial visits at Week 4 and every 6 weeks thereafter until Week 52. Participants who complete the Double-blind Treatment Period (Week 52) may be eligible to enter a 52-week extension trial (HZNP- HZN-825-302). Participants not entering the extension will return to the clinic for a Safety Follow-up Visit 4 weeks after the last dose of trial drug.
Phase
2Span
139 weeksSponsor
Horizon Therapeutics Ireland DACShinjuku-ku
Recruiting
AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis
This is a multicentre prospective international study. This study aims at developing a new simple endoscopic score using white light endoscopy - high definition (WLE-HD), Texture and colour enhancement imaging (TXI), red dichromatic imaging (RDI) and narrow-band imaging (NBI) modes, focusing on vascular features to distinguish between quiescent versus patchy mild Ulcerative Colitis. It will evaluate the new score's diagnostic performance in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes. Finally, it also aims to develop and adapt existing artificial intelligence (AI) algorithms according to WLE-HD, TXI, RDI and NBI to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcomes. The study will be divided in several phases: - In the first phase, the score will be developed on the first 30 consecutive virtual electronic chromoendoscopy (VCE) videos (using TXI-RDI and NBI) of UC patients, with different grade of disease activity. Experts in inflammatory bowel disease (IBD) endoscopy will review images and videos from recruited patients to define the endoscopic mucosal and vascular features of the new score. These will be used for a stepwise discussion. A round table discussion using modified Delphi method will be conducted by experts worldwide to ensure equal participation and identify the best component descriptors of endoscopic vascular healing. The components that will achieve 100% consensus will be selected, and the most important endoscopy predictive variables will be confirmed by using a machine learning technique. Finally, a new endoscopic score will be generated. This should be reproducible, valid and responsive. - In the second phase, the new endoscopic scoring system will be validated in a large cohort of UC patients, focusing on patients with quiescent disease versus patchy mild colitis. Diagnostic accuracy, interobserver agreement and ability to predict clinical outcome according to the new endoscopic score focused on vascular features assessed with VCE will be evaluated - In the third phase, the reproducibility of the new endoscopic scoring system will be evaluated among gastroenterologists with different levels of experience through a short survey and a computerised training module. - In the fourth phase, new and existing AI algorithms will be developed and adapted to these endoscopic videos and histological images to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcome in UC.
Phase
N/ASpan
152 weeksSponsor
University College CorkTokyo
Recruiting
A Clinical Study of ONO-1110 in Patients With Hunner Type Interstitial Cystitis
Phase
2Span
79 weeksSponsor
Ono Pharmaceutical Co. LtdTokyo
Recruiting
A Clinical Study of ONO-1110 in Patients With Fibromyalgia
Phase
2Span
83 weeksSponsor
Ono Pharmaceutical Co. LtdTokyo
Recruiting
A Study of Dengue Tetravalent Vaccine (TDV) in Healthy Participants in Japan
Phase
2/3Span
48 weeksSponsor
TakedaTokyo
Recruiting
Healthy Volunteers
ONO-4059 Study in Patients With Steroid-resistant Pemphigus
Phase
3Span
346 weeksSponsor
Ono Pharmaceutical Co. LtdTokyo
Recruiting
Tokyo
Recruiting