NCT03758443|TerminatedPhase 2ResultsDMCFDA Drug

Study Stopped

Stopped early due to company decision. Company decision based on interim analysis results in TD-1473-0157.

Efficacy & Safety of TD-1473 in Ulcerative Colitis

RHEA

A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis

Theravance Biopharma ClinicalTrials.gov

Compare

2 other identifiers

01572018-002136-24

Study Type

interventional

Target

239

Locations

22 countries

Sites

188

Timeline

RegisteredNov 2018

StartedMar 2019

CompletionOct 2021

Brief Summary

A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

Trial Health

Monitor

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

239

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Mar 2019

Geographic Reach

22 countries

188 active sites

Status

terminated

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

2.6 years study duration

First Submitted

Initial submission to the registry

November 19, 2018

Completed

10 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed

3 months until next milestone

Study Start

First participant enrolled

March 11, 2019

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2021

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

November 15, 2022

Completed

Last Updated

November 15, 2022

Status Verified

November 1, 2021

Enrollment Period

2.6 years

First QC Date

November 19, 2018

Results QC Date

October 21, 2022

Last Update Submit

October 21, 2022

Conditions

Ulcerative Colitis (UC)

Keywords

TD-1473Janus kinase inhibitorJAK inhibitorInflammatory Bowel DiseaseIBDUlcerative colitisUCGut selective

Outcome Measures

Primary Outcomes (2)

Change From Baseline in Total Mayo Score (tMS) at Week 8
Total Mayo Score (tMS) was calculated as the sum of four components: rectal bleeding (0-3), stool frequency (0-3), physician's global assessment (0-3) and Mayo endoscopic subscore (0-3). tMS was reported as a 0-12 point score with 12 reflecting the highest severity.
Baseline to Week 8
Phase 3 Maintenance: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Maintenance Week (mWeek) 44
Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1. The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity. Participants with missing Week 44 values were imputed as non-responders.
mWeek 44

Secondary Outcomes (4)

Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8
Week 8
Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 44
Baseline to mWeek 44
Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 44
mWeek 44
Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 44
mWeek 44

Study Arms (4)

Active Treatment TD-1473 Dose A

EXPERIMENTAL

Participants will be randomized to receive an oral daily dose of TD-1473. Responders will be re-randomized into the Phase 3 Maintenance portion of the study. Non-responders may participate in an extended induction.

Drug: TD-1473 Dose A

Active Treatment TD-1473 Dose B

EXPERIMENTAL

Drug: TD-1473 Dose B

Active Treatment TD-1473 Dose C

EXPERIMENTAL

Drug: TD-1473 Dose C

Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive an oral daily dose of placebo. Participants who received Placebo (and were non-responders) may move to an extended induction. Subjects who are on placebo will be assigned to active TD-1473 for the extended induction (they will be blinded to dose).

Drug: Placebo

Interventions

TD-1473 Dose ADRUG

See Arm description

Active Treatment TD-1473 Dose A

TD-1473 Dose BDRUG

See Arm description

Active Treatment TD-1473 Dose B

TD-1473 Dose CDRUG

See Arm description

Active Treatment TD-1473 Dose C

PlaceboDRUG

See Arm description

Placebo

Eligibility Criteria

Age18 Years+

Sexall(Gender-based eligibility)

Healthy VolunteersNo

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

You may qualify if:

Is at least 18 years of age at screening
Has a history of UC for at least 3 months prior to screening
Has moderately-to-severely active UC, as defined by a Mayo endoscopic subscore of ≥2 points and an adapted Mayo score between 4 - 9 points inclusive
Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to conventional therapy (aminosalicylates, corticosteroids, immunomodulators) or biologics
Willing to use highly-effective methods of contraception during the study and for 7 days after the last dose

You may not qualify if:

Has symptoms suggestive of fulminant colitis, megacolon or intestinal perforation
Likely to require surgery for UC or other major surgeries
Has previously received / is currently receiving prohibited medications within specified timeframe
Is refractory to 3 biologics with ≥2 mechanisms of action
Has a current bacterial, parasitic, fungal, or viral infection
Has clinically significant abnormalities in laboratory evaluations
Has had any prior exposure to an approved Janus kinase (JAK) inhibitor or potential exposure to an investigational JAK inhibitor that was stopped due to intolerance or lack of efficacy

Contact the study team to confirm eligibility.