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Phase 1b Clinical Study in Patients With Active Ulcerative Colitis

ConditionUlcerative Colitis (UC)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThetis Pharmaceuticals LLC

About this trial

Purpose of study is to evaluate the safety, tolerability, pharmacokinetics of TP317 vs. placebo in adults with active ulcerative colitis. Participants will be randomly assigned to receive either daily oral tablets (8 tablets) of TP317 (80 mg) or an identical placebo pill. Study will include 2 colonoscopies, daily dosing (including at home and in clinic), safety assessments, diary and questionnaire completion and 5 in clinic visits.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of UC with disease duration of at least 12 weeks prior to randomization

MMS of 5 to 8, inclusive;

ES ≥ 2;

RBS of ≥ 1; and

Disqualifiers

Likeliness to require hospitalization for medical care or surgical intervention of any kind for UC (e.g., colectomy) within 12 weeks after randomization

Current evidence of fulminant colitis, toxic megacolon, or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation

Pulse >90 bpm

Oral temperature of >37.8 °C

Trial design

Design model

Parallel

Treatments tested in this trial

  • TP317

    Drug

    8 tablets (80 mg) of TP317 oral tablets, taken once daily under fasted conditions for a total duration of 12 weeks.

  • Matching placebo

    Drug

    Matching oral tablet containing no active ingredients, taken once daily for 12 weeks to maintain blinding.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Active TP317 80 mgActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety of TP317

Incidence, duration and severity of all adverse events (AEs).

Time frame
Collected from baseline through Week 12
2

Safety of TP317

Number of Participants with Clinically Significant Laboratory Abnormalities

Time frame
Baseline through Week 12
3

Safety of TP317

Number of Participants with Clinically Significant ECG Abnormalities

Time frame
Baseline through Week 12
4

Safety of TP317

Changes in 12-lead electrocardiogram parameters

Time frame
Baseline to Week 12

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thetis Pharmaceuticals LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: