NCT03635112|TerminatedPhase 2ResultsDMCFDA Drug

Study Stopped

The study was terminated by the sponsor on 16 November 2021 after a planned review by the Independent Data Monitoring Committee.

Efficacy and Safety of TD-1473 in Crohn's Disease

DIONE

A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo˗Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy With 2 Doses of TD-1473 in Subjects With Moderately-to-Severely Active Crohn's Disease

Theravance Biopharma ClinicalTrials.gov

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2 other identifiers

01732018-001272-37

Study Type

interventional

Target

167

Locations

21 countries

Sites

175

Timeline

RegisteredAug 2018

StartedNov 2018

CompletionDec 2021

Brief Summary

A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 48 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

167

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2018

Typical duration for phase_2

Geographic Reach

21 countries

175 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

3.1 years study duration

First Submitted

Initial submission to the registry

July 31, 2018

Completed

17 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed

3 months until next milestone

Study Start

First participant enrolled

November 19, 2018

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

March 13, 2023

Completed

Last Updated

March 13, 2023

Status Verified

February 1, 2023

Enrollment Period

3.1 years

First QC Date

July 31, 2018

Results QC Date

December 30, 2022

Last Update Submit

February 14, 2023

Conditions

Crohn's Disease

Keywords

TD-1473Janus kinase inhibitorJAK inhibitorInflammatory Bowel DiseaseIBDCrohn's DiseaseIntestinal restriction

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Crohn's Disease Activity Index (CDAI) Score
The CDAI score was generated using regression coefficients for eight different predictors of disease activity: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Benchmarks for disease activity as measured by the CDAI were: \<150, clinical remission; 150 to 219, mildly active disease; 220-450, moderately active disease; and \>450, very severe disease.
Baseline to Week 12

Secondary Outcomes (5)

Number of Participants Who Demonstrated a Clinical Response as Measured by CDAI
Week 12
Number of Participants Who Demonstrated CDAI Clinical Remission
Week 12
Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
Baseline to Week 12
Number of Participants With Endoscopic Response at Week 12
Week 12
Number of Participants With Stool Frequency and Abdominal Pain (SFAP) Clinical Remission
Week 12

Study Arms (3)

Active Treatment TD-1473 with Dose A

ACTIVE COMPARATOR

1 oral Dose A daily of TD-1473 for 12 weeks in subjects with moderately to-severely active CD. Subjects who complete Induction will continue to receive TD-1473 at Dose A in the Active Treatment Arm for up to 48 additional weeks.

Drug: TD-1473

Active Treatment TD-1473 with Dose B

ACTIVE COMPARATOR

1 oral Dose B daily of TD-1473 for 12 weeks in subjects with moderately to-severely active CD. Subjects who complete Induction will continue to receive TD-1473 at Dose B in the Active Treatment Arm for up to 48 additional weeks.

Drug: TD-1473

Placebo

PLACEBO COMPARATOR

1 oral dose daily of placebo for 12 weeks in subjects with moderately to-severely active CD. Subjects who complete Induction will receive TD-1473 at Dose A in the Active Treatment Arm for up to 48 additional weeks.

Drug: PlaceboDrug: TD-1473

Interventions

PlaceboDRUG

Placebo will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating.

Placebo

TD-1473DRUG

TD-1473, at Dose A or Dose B depending upon arm, will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating. An additional 48 weeks either at Dose A or Dose B, depending on arm, may be administered if subjects finish the 12 week induction period.

Active Treatment TD-1473 with Dose AActive Treatment TD-1473 with Dose BPlacebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Is at least 18 years of age at screening
Males and females with clinical evidence of Crohn's disease for at least 3 months duration at screening
Moderately-to-severely active Crohn's Disease at baseline, as defined by a Crohn's Disease Activity Index (CDAI) score of 220-450 inclusive
SES-CD score of ≥ 3 with ulceration (corresponding to a score of 1) in at least 1 of the 5 ileocolonic segments on the Ulcerated Surface subscore of the SES-CD\]
Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to conventional therapy (aminosalicylates, corticosteroids and immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate) or biologics (e.g., anti-TNF therapy, anti-IL-12/23 (anti-interleukin), anti-integrin).

You may not qualify if:

Is currently receiving biologic (anti-TNF, anti-integrin, or anti-IL12/23) therapy
Has a current bacterial, parasitic, fungal, or viral infection
Has clinically significant abnormalities in laboratory evaluations
Prior exposure or potential exposure to a JAK inhibitor that was stopped due to intolerance or lack of efficacy
Subject has participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening or 5x the half-life of the investigational drug, whichever is longer, or is currently participating in another trial of an investigational drug (or medical device)
Subject has failed ≥ 3 biologic agents of 3 different mechanisms of action (i.e., anti-TNF, anti-integrin, and anti-IL12/23)

Contact the study team to confirm eligibility.