UCNot yet recruiting
A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of PTT-621 in Patients With Moderately to Severely Active Ulcerative Colitis
Phase 2 · Testing PTT-621 Tablets · 1 site · Pyrotech Therapeutics, Inc.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing PTT-621 Tablets (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC).
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 6 more requirement(s). There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2026-08 (planned).
- Main results expected around 2027-12 (estimate from the record).
- 1 study site listed in China.
Main thing being measured
- Percentage of participants achieving endoscopic improvement at Week 12 (Week 12)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | Pyrotech Therapeutics, Inc. |
| Enrollment | 40 (estimated) |
| Start date | 2026-08 |
| Primary completion (est.) | 2027-12 |
| First posted | 2026-08-05 |
| Last updated | 2026-08-07 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT07747155 |
Interventions
- PTT-621 Tablets (Drug)
PTT-621 will be administered orally
Full eligibility criteria (from the record)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Renji Hospital-Shanghai Jiao Tong University School of Medicine | Shanghai, Shanghai Municipality | China |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.