NCT02818686|CompletedPhase 1FDA Drug

TD-1473 for Active Ulcerative Colitis (UC)

A Phase 1b Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Plasma Exposure of TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis

Theravance Biopharma ClinicalTrials.gov

Compare

2 other identifiers

01442016-001633-27

Study Type

interventional

Target

Locations

4 countries

Sites

Timeline

RegisteredJun 2016

StartedOct 2016

CompletionMar 2018

Brief Summary

This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TD-1473 in subjects with moderately-to-severely active UC over 28 days. This exploratory study will also serve as a signal seeking endeavor to demonstrate biologic effect associated with TD-1473 through biomarker analysis and clinical, endoscopic, and histologic assessments.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Oct 2016

Geographic Reach

4 countries

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

June 23, 2016

Completed

7 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed

3 months until next milestone

Study Start

First participant enrolled

October 3, 2016

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2018

Completed

Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

1.5 years

First QC Date

June 23, 2016

Last Update Submit

September 28, 2021

Conditions

Ulcerative Colitis, Active Moderate Ulcerative Colitis, Active Severe

Keywords

Ulcerative Colitis, Active Moderate and Severe

Outcome Measures

Primary Outcomes (12)

Treatment-emergent Adverse Events (TEAE)
Number of participants who experience one or more treatment-emergent Adverse Events (TEAE)
Baseline to end of follow-up (a maximum of 42 days)
Moderate or Severe Treatment-emergent Adverse Events (TEAE)
Number of participants who experience one or more moderate or severe treatment-emergent Adverse Events (TEAE)
Baseline to end of follow-up (a maximum of 42 days)
Serious Treatment-emergent Adverse Events (TEAE)
Number of participants who experience one or more serious treatment-emergent Adverse Events (TEAE)
Baseline to end of follow-up (a maximum of 42 days)
Clinical Laboratory Measurements
Number of participants who experienced a Clinically Significant Clinical Laboratory Measurements
Baseline to end of follow-up (a maximum of 42 days)
Electrocardiogram
Number of participants who experienced a Clinically Significant Electrocardiogram (ECG) Result
Baseline to Day 14
Vital Signs
Number of participants who experienced a Clinically Significant Vital Sign Measurement
Baseline to end of follow-up (a maximum of 42 days)
Cmax in plasma
Maximum Observed Plasma Concentration of TD-1473
Day 1 and Day 14
Tmax in plasma
Time to Reach Maximum Observed Plasma Concentration (Cmax) of TD-1473
Day 1 and Day 14
Tlast in plasma
Time to Last Quantifiable Concentration of TD-1473
Day 1 and Day 14
Ctrough in plasma
Trough Concentration of TD-1473
Day 14 (Pre-dose)
AUC0-4 in plasma
Area Under the Concentration-time Curve from Time Zero to 4 hours Post-Dose of TD-1473
Day 1 and Day 14
Ctissue in plasma
Tissue Concentration of TD-1473
Day 28

Secondary Outcomes (3)

C-reactive protein (CRP)
Baseline, Day 14 and Day 28
Fecal Calprotectin
Baseline and Day 28
Partial Mayo score
Baseline, Day 14 and Day 28

Study Arms (4)

TD-1473 low dose

EXPERIMENTAL

10 subjects will be randomized to receive low-dose TD-1473 orally daily for 28 days

Drug: TD-1473

TD-1473 mid dose

EXPERIMENTAL

10 subjects will be randomized to receive mid-dose TD-1473 orally daily for 28 days

Drug: TD-1473

TD-1473 high dose

EXPERIMENTAL

10 subjects will be randomized to receive high-dose TD-1473 orally daily for 28 days

Drug: TD-1473

Placebo

PLACEBO COMPARATOR

10 subjects will be randomized to receive placebo orally daily for 28 days

Drug: Placebo

Interventions

TD-1473DRUG

TD-1473 high doseTD-1473 low doseTD-1473 mid dose

PlaceboDRUG

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Has a history of ulcerative colitis diagnosis at least 3 months prior to screening
Is intolerant, refractory, or only partially responsive to aminosalicylates, corticosteroids, immunomodulators, or biologics. If subject is currently receiving an oral aminosalicylate, he or she is eligible and can stay on that dose of aminosalicylate provided the dose has been stable for at least 2 weeks prior to screening. If the subject is currently receiving an oral corticosteroid, he or she is eligible if the dose is equivalent to or less than prednisone 20 mg/day or budesonide 9 mg/day and stable for at least 2 weeks prior to screening sigmoidoscopy if the subject has been on corticosteroids for more than 2 weeks.
Has a rectal bleeding score ≥ 1 and a bowel frequency score ≥ 1 on the patient-reported outcome 2 (PRO2) on screening sigmoidoscopy day and on Day 1 in addition to a modified Mayo endoscopic subscore of ≥ 2 during screening
Women of childbearing potential must have a negative pregnancy test and either abstain from sexual intercourse or use a highly effective method of birth control
Willing and able to give informed consent

You may not qualify if:

Has fulminant colitis, toxic megacolon, primary sclerosing cholangitis, Crohn's disease, history of colitis-associated colonic dysplasia, active peptic ulcer disease
Has a current bacterial, parasitic, fungal, or viral infection
Is positive for hepatitis A, B or C, HIV or tuberculosis
Has clinically significant abnormalities in laboratory evaluations
Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening (or within 60 days prior to screening if investigational drug was a biologic or another Janus kinase (JAK) inhibitor, or is currently participating in another trial of an investigational drug (or medical device)
Use of prescription medications started or with a dose adjustment within 4 weeks prior to study enrollment, or over-the-counter medications or supplements started or with a dose adjustment within 2 weeks prior study enrollment. Anti-diarrheal medications are allowed only if dose has been stable at least 2 weeks prior to study enrollment

Contact the study team to confirm eligibility.