NCT07747155Not yet recruitingPhase 2
A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of PTT-621 in Patients With Moderately to Severely Active Ulcerative Colitis
A Phase IIa, Multicenter, Single-Arm Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Characteristics of PTT-621 in Patients With Moderately to Severely Active Ulcerative
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
This Phase IIa, multicenter, single-arm trial evaluates the efficacy, safety, tolerability, and pharmacokinetics of PTT-621 tablets in adults (18-70 years) with moderate-to-severe active ulcerative colitis (UC) who have inadequate response/intolerance to standard therapies. Participants receive PTT-621 for 12 weeks. The primary endpoint is the proportion of participants achieving endoscopic improvement at Week 12. Secondary endpoints include safety, clinical remission, clinical response, symptom response, pharmacokinetics, and inflammatory biomarkers. The study is sponsored by Pyrotech Therapeutics, with ethical approval from Renji Hospital's IRB.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 27 Jul 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Pyrotech Therapeutics, Inc.
- Diseases
- Ulcerative colitis
- NCT number
- NCT07747155
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 1 Aug 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1\. A current diagnosis of Crohn's disease (CD), indeterminate colitis, infectious colitis, or any other colitis/enteritis that could interfere with efficacy evaluation； 2. Has UC complications (e.g., fulminant colitis, toxic megacolon, prior total or partial colectomy, or other conditions requiring surgery)； 3. Prior or current gastrointestinal dysplasia； 4. History of gastrointestinal malignancy, or any current evidence of gastrointestinal cancer.
Who the study is looking for
- 1\. Male or female participants aged 18-70 years inclusive at screening. 2. Diagnosed with ulcerative colitis (UC) at least 60 days prior to the first dose of IP.
- 3\. Participants have active UC at screening, defined as a modified Mayo score of 5-9.
- 4\. Endoscopic evidence of UC extending ≥15 cm from the anal verge during the screening period.
- 5\. Participants have had inadequate/loss of response or intolerance to at least one of the following: 5-aminosalicylic acid, glucocorticoids, immunosuppressants, biologics, and/or small-molecule targeted therapies.
- 6\. Participants currently receiving the following UC therapies are eligible if they meet stability requirements: Oral glucocorticoids: with stable dosing for ≥2 weeks prior to screening endoscopy；Oral 5-ASA: Stable dose for at least 2 weeks prior to the endoscopic assessment during the screening period.
- 7\. Female participants of childbearing potential must have a negative serum/urine pregnancy test at screening.
- 8\. Willing to use at least one highly effective contraceptive method during sexual intercourse throughout the study and until 1 month after the last dose of IP.
- 9\. Willing to refrain from sperm/ova donation throughout the study and until 1 month after the last dose of IP.
- 10\. Able and willing to provide written informed consent and comply with all protocol-specified procedures and visit schedules.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Renji Hospital Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.