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TerminatedNCT03758443RHEAUpdated Nov 15, 2022Results posted

Efficacy & Safety of TD-1473 in Ulcerative Colitis

A Phase 2/3 interventional study of TD-1473 Dose A and TD-1473 Dose B in Ulcerative Colitis (UC), sponsored by Theravance Biopharma. Terminated at 188 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-15.

Sponsored by Theravance Biopharma · Phase 2/3, Interventional, and Treatment

Why this study was terminated
Stopped early due to company decision. Company decision based on interim analysis results in TD-1473-0157.
Phase
Phase 2/3
Study type
Interventional
Enrollment
239
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This protocol consists of 3 separate studies: an 8-week Phase 2b dose-finding induction study, an 8-week dose-confirming Phase 3 induction study, and a 44-week Phase 3 maintenance study. Subjects who respond to induction will enter the maintenance study; those who do not will receive TD-1473 during extended induction. The safety and efficacy data of the Phase 2b study will be analyzed to select the induction and maintenance dose regimens for the confirmatory Phase 3 studies. Participants who have disease relapse or complete the maintenance study may be eligible to enter a separate long-term safety study. Efficacy, pharmacokinetic, biomarkers, and safety will be evaluated in all 3 studies.

240 subjects are planned for the Phase 2b and the planned Primary Completion Date for this portion of the study is JULY 2021. 640 subjects are planned for the Phase 3 portion of the study.

02

Conditions studied

  • Ulcerative Colitis (UC)

Keywords

  • TD-1473
  • Janus kinase inhibitor
  • JAK inhibitor
  • Inflammatory Bowel Disease
  • IBD
  • Ulcerative colitis
  • UC
  • Gut selective
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 239 is above the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Theravance Biopharma is the lead sponsor of 47 studies on the registry; none are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 11 (46%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • Additional inclusion criteria apply

Exclusion criteria

Exclusion Criteria:

  • 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
  • Additional exclusion criteria apply
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
239 participants (actual)

Study arms

  • Experimental
    Active Treatment TD-1473 Dose A

    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

  • Experimental
    Active Treatment TD-1473 Dose B

    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 B

  • Experimental
    Active Treatment TD-1473 Dose C

    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 C

  • Placebo comparator
    Placebo

    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

  • DrugTD-1473 Dose A

    See Arm description

  • DrugTD-1473 Dose B

    See Arm description

  • DrugTD-1473 Dose C

    See Arm description

  • DrugPlacebo

    See Arm description

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to Week 8

  2. 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.

    Time frame: mWeek 44

Secondary outcomes

  1. Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8

    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.

    Time frame: Week 8

  2. Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 44

    Clinical response was defined as a reduction from baseline in adapted Mayo score of ≥ 2 points and ≥ 30% relative to baseline. It also required ≥ 1 reduction in the rectal bleeding subscore or an absolute subscore ≤ 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.

    Time frame: Baseline to mWeek 44

  3. Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 44

    Endoscopic remission was defined as an endoscopic subscore ≤ 1. Endoscopic subscore was measured using scale of 0-3, where higher numbers reflected greater severity.

    Time frame: mWeek 44

  4. Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 44

    Symptomatic remission was defined as a stool frequency score ≤ 1 and a rectal bleeding subscore of 0. Stool frequency score and rectal bleeding score were each measured using scale of 0-3, where higher numbers reflected greater severity. Participants with missing Week 44 values were imputed as non-responders.

    Time frame: mWeek 44

07

Results

Posted Nov 15, 2022
Limitations and caveats
The study was terminated early due to a company decision based on interim analysis results in TD-1473-0157. Therefore, the Phase 3 dose-confirming Induction Study was not conducted and the Maintenance Study was prematurely terminated.

Participant flow

A total of 239 participants were enrolled at sites in Europe, Asia/Pacific, the United States, Israel, Australia, and South Africa between 11 March 2019 and 20 October 2021.

Induction Period
Participant flow — Induction Period
MilestonePlaceboTD-1473 20 mgTD-1473 80 mgTD-1473 200 mg
Started61615958
Completed55545250
Not completed6778
Withdrew: Adverse event2423
Withdrew: Physician decision1130
Withdrew: Protocol violation0001
Withdrew: Withdrawal by subject3224
Extended Induction Period
Participant flow — Extended Induction Period
MilestonePlaceboTD-1473 20 mgTD-1473 80 mgTD-1473 200 mg
Started42323229
Completed29292322
Not completed13397
Withdrew: Adverse event1101
Withdrew: Lost to follow-up1000
Withdrew: Physician decision2122
Withdrew: Protocol violation0001
Withdrew: Withdrawal by subject8173
Withdrew: Miscellaneous1000
Maintenance Period
Participant flow — Maintenance Period
MilestonePlaceboTD-1473 20 mgTD-1473 80 mgTD-1473 200 mg
Started29312522
Completed1311129
Not completed16201313
Withdrew: Adverse event1200
Withdrew: Lost to follow-up0001
Withdrew: Persistent loss of response during maintenance3120
Withdrew: Protocol violation0100
Withdrew: Study terminated by sponsor1116911
Withdrew: Withdrawal by subject1011
Withdrew: Miscellaneous0010

Outcome measures

PrimaryChange 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.

Time frame:
Baseline to Week 8
Reported as:
Least squares mean · score on a scale
Change From Baseline in Total Mayo Score (tMS) at Week 8
score on a scaleInduction Period: PlaceboInduction Period: TD-1473 20 mgInduction Period: TD-1473 80 mgInduction Period: TD-1473 200 mg
Change From Baseline in Total Mayo Score (tMS) at Week 8-1.75 ± 0.341-2.02 ± 0.350-2.12 ± 0.351-2.40 ± 0.346
Statistical analysis
  • Induction Period: Placebo vs Induction Period: TD-1473 20 mg · ANCOVA · p = 0.5809 · Least square mean difference: -0.27 · 95% CI -1.22 to 0.69
  • Induction Period: Placebo vs Induction Period: TD-1473 80 mg · ANCOVA · p = 0.4501 · Least square mean difference: -0.37 · 95% CI -1.33 to 0.59
  • Induction Period: Placebo vs Induction Period: TD-1473 200 mg · ANCOVA · p = 0.1809 · Least square mean difference: -0.65 · 95% CI -1.60 to 0.30
PrimaryPhase 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.

Time frame:
mWeek 44
Reported as:
Count of participants · Participants
Phase 3 Maintenance: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Maintenance Week (mWeek) 44
ParticipantsMaintenance Period: PlaceboMaintenance Period: TD-1473 20 mgMaintenance Period: TD-1473 80 mgMaintenance Period: TD-1473 200 mg
Phase 3 Maintenance: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Maintenance Week (mWeek) 444353
Statistical analysis
  • Maintenance Period: Placebo vs Maintenance Period: TD-1473 20 mg · Fisher Exact · p = 0.3762
  • Maintenance Period: Placebo vs Maintenance Period: TD-1473 80 mg · Fisher Exact · p = 1.0000
  • Maintenance Period: Placebo vs Maintenance Period: TD-1473 200 mg · Fisher Exact · p = 1.0000
SecondaryNumber of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8

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.

Time frame:
Week 8
Reported as:
Count of participants · Participants
Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8
ParticipantsInduction Period: PlaceboInduction Period: TD-1473 20 mgInduction Period: TD-1473 80 mgInduction Period: TD-1473 200 mg
Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 86644
Statistical analysis
  • Induction Period: Placebo vs Induction Period: TD-1473 20 mg · Cochran-Mantel-Haenszel · p = 0.9542 (P-value is shown for Cochran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.) · Difference in proportion: 0.00 · 95% CI -0.104 to 0.110Difference in proportion estimates used Mantel-Haenszel stratum weights.
  • Induction Period: Placebo vs Induction Period: TD-1473 80 mg · Cochran-Mantel-Haenszel · p = 0.5863 (P-value is shown for Cochran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.) · Difference in proportion: -0.03 · 95% CI -0.126 to 0.071Difference in proportion estimates used Mantel-Haenszel stratum weights.
  • Induction Period: Placebo vs Induction Period: TD-1473 200 mg · Cochran-Mantel-Haenszel · p = 0.5408 (P-value is shown for Conhran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.) · Difference in proportion: -0.03 · 95% CI -0.131 to 0.069Difference in proportion estimates used Mantel-Haenszel stratum weights.
SecondaryPhase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 44

Clinical response was defined as a reduction from baseline in adapted Mayo score of ≥ 2 points and ≥ 30% relative to baseline. It also required ≥ 1 reduction in the rectal bleeding subscore or an absolute subscore ≤ 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.

Time frame:
Baseline to mWeek 44
Reported as:
Count of participants · Participants
Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 44
ParticipantsMaintenance Period: PlaceboMaintenance Period: TD-1473 20 mgMaintenance Period: TD-1473 80 mgMaintenance Period: TD-1473 200 mg
Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 445586
Statistical analysis
  • Maintenance Period: Placebo vs Maintenance Period: TD-1473 20 mg · Fisher Exact · p = 0.6656
  • Maintenance Period: Placebo vs Maintenance Period: TD-1473 80 mg · Fisher Exact · p = 0.6424
  • Maintenance Period: Placebo vs Maintenance Period: TD-1473 200 mg · Fisher Exact · p = 0.6199
SecondaryPhase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 44

Endoscopic remission was defined as an endoscopic subscore ≤ 1. Endoscopic subscore was measured using scale of 0-3, where higher numbers reflected greater severity.

Time frame:
mWeek 44
Reported as:
Count of participants · Participants
Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 44
ParticipantsMaintenance Period: PlaceboMaintenance Period: TD-1473 20 mgMaintenance Period: TD-1473 80 mgMaintenance Period: TD-1473 200 mg
Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 443132
Statistical analysis
  • Maintenance Period: Placebo vs Maintenance Period: TD-1473 20 mg · Fisher Exact · p = 0.2643
  • Maintenance Period: Placebo vs Maintenance Period: TD-1473 80 mg · Fisher Exact · p = 1.0000
  • Maintenance Period: Placebo vs Maintenance Period: TD-1473 200 mg · Fisher Exact · p = 1.0000
SecondaryPhase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 44

Symptomatic remission was defined as a stool frequency score ≤ 1 and a rectal bleeding subscore of 0. Stool frequency score and rectal bleeding score were each measured using scale of 0-3, where higher numbers reflected greater severity. Participants with missing Week 44 values were imputed as non-responders.

Time frame:
mWeek 44
Reported as:
Count of participants · Participants
Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 44
ParticipantsMaintenance Period: PlaceboMaintenance Period: TD-1473 20 mgMaintenance Period: TD-1473 80 mgMaintenance Period: TD-1473 200 mg
Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 445775
Statistical analysis
  • Maintenance Period: Placebo vs Maintenance Period: TD-1473 20 mg · Fisher Exact · p = 1.0000
  • Maintenance Period: Placebo vs Maintenance Period: TD-1473 80 mg · Fisher Exact · p = 1.0000
  • Maintenance Period: Placebo vs Maintenance Period: TD-1473 200 mg · Fisher Exact · p = 1.0000

Adverse events

Collected over Induction Period: Up to Week 20 Maintenance Period: Up to Week 48. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Induction Period: Placebo0/61 (0%)4/61 (6.6%)7/61 (11.5%)
Induction Period: TD-1473 20 mg0/61 (0%)4/61 (6.6%)11/61 (18%)
Induction Period: TD-1473 80 mg0/59 (0%)2/59 (3.4%)9/59 (15.3%)
Induction Period: Placebo to TD-1473 80 mg0/42 (0%)3/42 (7.1%)4/42 (9.5%)
Induction Period: TD-1473 200 mg0/58 (0%)4/58 (6.9%)14/58 (24.1%)
Maintenance Period: Placebo0/29 (0%)1/29 (3.4%)6/29 (20.7%)
Maintenance Period: TD-1473 20 mg0/31 (0%)2/31 (6.5%)14/31 (45.2%)
Maintenance Period: TD-1473 80 mg0/25 (0%)2/25 (8%)5/25 (20%)
Maintenance Period: TD-1473 200 mg0/22 (0%)1/22 (4.5%)1/22 (4.5%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
EventInduction Period: PlaceboInduction Period: TD-1473 20 mgInduction Period: TD-1473 80 mgInduction Period: Placebo to TD-1473 80 mgInduction Period: TD-1473 200 mgMaintenance Period: PlaceboMaintenance Period: TD-1473 20 mgMaintenance Period: TD-1473 80 mgMaintenance Period: TD-1473 200 mg
Colitis ulcerativeGastrointestinal disorders2/613/611/591/422/580/290/311/251/22
Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/610/610/590/420/580/290/311/250/22
Urethral stenosisRenal and urinary disorders0/610/610/590/420/581/290/310/250/22
Tubulointerstitial nephritisRenal and urinary disorders0/610/610/590/420/580/291/310/250/22
Joint injuryInjury, poisoning and procedural complications0/610/610/590/420/580/291/310/250/22
Atrial fibrillationCardiac disorders0/610/610/591/420/580/290/310/250/22
Back painMusculoskeletal and connective tissue disorders0/610/610/591/420/580/290/310/250/22
Angina pectorisCardiac disorders0/610/610/590/421/580/290/310/250/22
AnaemiaBlood and lymphatic system disorders0/610/610/590/421/580/290/310/250/22
Large intestine operationSurgical and medical procedures0/610/611/590/420/580/290/310/250/22
Most frequent other events
Most frequent other events
EventInduction Period: PlaceboInduction Period: TD-1473 20 mgInduction Period: TD-1473 80 mgInduction Period: Placebo to TD-1473 80 mgInduction Period: TD-1473 200 mgMaintenance Period: PlaceboMaintenance Period: TD-1473 20 mgMaintenance Period: TD-1473 80 mgMaintenance Period: TD-1473 200 mg
Colitis ulcerativeGastrointestinal disorders1/613/615/591/427/584/296/313/250/22
NasopharyngitisInfections and infestations1/616/610/590/424/580/290/311/250/22
AnaemiaBlood and lymphatic system disorders1/612/612/591/422/581/293/310/251/22
Upper respiratory tract infectionInfections and infestations1/611/611/592/420/582/290/310/250/22
HeadacheNervous system disorders2/610/612/591/422/581/292/311/250/22
HaemorrhoidsGastrointestinal disorders0/610/611/590/420/580/292/310/250/22
PyrexiaGeneral disorders2/610/610/590/420/580/292/310/250/22

Baseline characteristics

The Intent-to-treat population included all randomized participants.

Age, Continuous
Age, Continuous(years)PlaceboTD-1473 20 mgTD-1473 80 mgTD-1473 200 mgTotal
Mean40.92 ± 15.39038.87 ± 14.57642.02 ± 15.31744.38 ± 14.12241.51 ± 14.905
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboTD-1473 20 mgTD-1473 80 mgTD-1473 200 mgTotal
Female2717202993
Male34443929146
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboTD-1473 20 mgTD-1473 80 mgTD-1473 200 mgTotal
Hispanic or Latino32117
Not Hispanic or Latino54595655224
Unknown or Not Reported40228
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboTD-1473 20 mgTD-1473 80 mgTD-1473 200 mgTotal
White48505151200
Black or African American10001
Asian9116632
Other30216
08

Study locations

188 sites
  • Theravance Biopharma Investigational Site
    Chula Vista, California 91911, United States
  • Theravance Biopharma Investigational Site
    La Jolla, California 92037, United States
  • Theravance Biopharma Investigational Site
    Lancaster, California 93534, United States
  • Theravance Biopharma Investigational Site
    Orange, California 92866, United States
  • Theravance Biopharma Investigational Site
    Colorado Springs, Colorado 80920, United States
  • Theravance Biopharma Investigational Site
    Aventura, Florida 33180, United States
  • Theravance Biopharma Investigational Site
    Clearwater, Florida 33756, United States
  • Theravance Biopharma Investigational Site
    Largo, Florida 33777, United States
  • Theravance Biopharma Investigational Site
    Miami, Florida 33135, United States
  • Theravance Biopharma Investigational Site
    Miami, Florida 33155, United States
  • Theravance Biopharma Investigational Site
    New Port Richey, Florida 34653, United States
  • Theravance Biopharma Investigational Site
    New Smyrna Beach, Florida 32168, United States
  • Theravance Biopharma Investigational Site
    Orlando, Florida 32803, United States
  • Theravance Biopharma Investigational Site
    Pembroke Pines, Florida 33024, United States
  • Theravance Biopharma Investigational Site
    Atlanta, Georgia 30342, United States
  • Theravance Biopharma Investigational Site
    Suwanee, Georgia 30024, United States
  • Theravance Biopharma Investigational Site
    Idaho Falls, Idaho 83404, United States
  • Theravance Biopharma Investigational Site
    Kansas City, Kansas 66160, United States
  • Theravance Biopharma Investigational Site
    Louisville, Kentucky 40202, United States
  • Theravance Biopharma Investigational Site
    Monroe, Louisiana 71201, United States
  • Theravance Biopharma Investigational Site
    Baltimore, Maryland 21201, United States
  • Theravance Biopharma Investigational Site
    Troy, Michigan 48098, United States
  • Theravance Biopharma Investigational Site
    Wyoming, Michigan 48519, United States
  • Theravance Biopharma Investigational Site
    Rochester, Minnesota 55905, United States
  • Theravance Biopharma Investigational Site
    Kansas City, Missouri 64131, United States
  • Theravance Biopharma Investigational Site
    Las Vegas, Nevada 89123, United States
  • Theravance Biopharma Investigational Site
    New York, New York 10029, United States
  • Theravance Biopharma Investigational Site
    Charlotte, North Carolina 28215, United States
  • Theravance Biopharma Investigational Site
    Gastonia, North Carolina 28054, United States
  • Theravance Biopharma Investigational Site
    Greenville, North Carolina 27834-3761, United States
  • Theravance Biopharma Investigational Site
    Pittsburgh, Pennsylvania 15212, United States
  • Theravance Biopharma Investigational Site
    Smithfield, Pennsylvania 15478, United States
  • Theravance Biopharma Investigational Site
    Greenville, South Carolina 29615, United States
  • Theravance Biopharma Investigational Site
    Rock Hill, South Carolina 29732, United States
  • Theravance Biopharma Investigational Site
    Nashville, Tennessee 37212, United States
  • Theravance Biopharma Investigational Site
    Garland, Texas 75044, United States
  • Theravance Biopharma Investigational Site
    Houston, Texas 77002, United States
  • Theravance Biopharma Investigational Site
    San Antonio, Texas 78215, United States
  • Theravance Biopharma Investigational Site
    South Brisbane, Queensland 4101, Australia
  • Theravance Biopharma Investigational Site
    Woolloongabba, Queensland 4102, Australia
  • Theravance Biopharma Investigational Site
    Malvern, Victoria 3144, Australia
  • Theravance Biopharma Investigational Site
    Murdoch, Western Australia 6150, Australia
  • Theravance Biopharma Investigational Site
    Sofia, Sofiya 1303, Bulgaria
  • Theravance Biopharma Investigational Site
    Sofia, Sofiya 1527, Bulgaria
  • Theravance Biopharma Investigational Site
    Sofia, Sofiya 1784, Bulgaria
  • Theravance Biopharma Investigational Site (2)
    Pleven, 5800, Bulgaria
  • Theravance Biopharma Investigational Site
    Pleven, 5800, Bulgaria
  • Theravance Biopharma Investigational Site
    Plovdiv, 4002, Bulgaria
  • Theravance Biopharma Investigational Site
    Plovdiv, 4004, Bulgaria
  • Theravance Biopharma Investigational Site
    Ruse, 7005, Bulgaria
  • Theravance Biopharma Investigational Site
    Sliven, 8800, Bulgaria
  • Theravance Biopharma Investigational Site
    Sofia, 1712, Bulgaria
  • Theravance Biopharma Investigational Site
    Stara Zagora, 6000, Bulgaria
  • Theravance Biopharma Investigational Site
    Stara Zagora, 6001, Bulgaria
  • Theravance Biopharma Investigational Site
    Veliko Tarnovo, 5000, Bulgaria
  • Theravance Biopharma Investigational Site
    Kingston, Ontario K7L 5G2, Canada
  • Theravance Biopharma Investigational Site
    Reims, Champagne-ardenne 51092, France
  • Theravance Biopharma Investigational Site
    Montpellier Cedex 5, Languedoc-roussillon 34295, France
  • Theravance Biopharma Investigational Site
    Vandœuvre-lès-Nancy Cedex, Limousin 54500, France
  • Theravance Biopharma Investigational Site
    Toulouse Cedex 9, Midi-pyrenees 31059, France
  • Theravance Biopharma Investigational Site
    Lille Cedex, NORD Pas-de-calais 59037, France
  • Theravance Biopharma Investigational Site
    Nantes, PAYS DE LA Loire 44000, France
  • Theravance Biopharma Investigational Site
    Amiens Cedex 1, Picardie 80054, France
  • Theravance Biopharma Investigational Site
    Pierre Bénite, Rhone-alpes 69495, France
  • Theravance Biopharma Investigational Site
    Saint-Etienne, Rhone-alpes 42055, France
  • Theravance Biopharma Investigational Site
    Batumi, 6010, Georgia
  • Theravance Biopharma Investigational Site
    Tbilisi, 0114, Georgia
  • Theravance Biopharma Investigational Site
    Tbilisi, 0159, Georgia
  • Theravance Biopharma Investigational Site
    Heidelberg, Baden-wuerttemberg 69121, Germany
  • Theravance Biopharma Investigational Site
    Ulm, Baden-wuerttemberg 89081, Germany
  • Theravance Biopharma Investigational Site
    Kiel, Schleswig-holstein 24105, Germany
  • Theravance Biopharma Investigational Site
    Jena, Thuringen 07747, Germany
  • Theravance Biopharma Investigational Site
    Berlin, 10117, Germany
  • Theravance Biopharma Investigational Site
    Berlin, 13353, Germany
  • Theravance Biopharma Investigational Site
    Athens, Attica 115 27, Greece
  • Theravance Biopharma Investigational Site #2
    Athens, Attica 11527, Greece
  • Theravance Biopharma Investigational Site
    Heraklion, Crete 71110, Greece
  • Theravance Biopharma Investigational Site
    Patra, Peloponnese 265 04, Greece
  • Theravance Biopharma Investigational Site
    Székesfehérvár, Fejer 8000, Hungary
  • Theravance Biopharma Investigational Site
    Debrecen, Hajdu-bihar 4032, Hungary
  • Theravance Biopharma Investigational Site
    Szekszard, Tolna 7100, Hungary
  • Theravance Biopharma Investigational Site
    Budapest, 1088, Hungary
  • Theravance Biopharma Investigational Site
    Budapest, 1136, Hungary
  • Theravance Biopharma Investigational Site
    Zerifin, Rehoboth 7030000, Israel
  • Theravance Biopharma Investigational Site
    Haifa, 31048, Israel
  • Theravance Biopharma Investigational Site
    Holon, 5822012, Israel
  • Theravance Biopharma Investigational Site
    Jerusalem, 9362410, Israel
  • Theravance Biopharma Investigational Site
    Nahariya, 2210001, Israel
  • Theravance Biopharma Investigational Site
    Petah Tikva, 4941492, Israel
  • Theravance Biopharma Investigational Site
    Rehovot, 7661041, Israel
  • Theravance Biopharma Investigational Site
    Rozzano, Milano 20089, Italy
  • Theravance Biopharma Investigational Site
    Catanzaro, 88100, Italy
  • Theravance Biopharma Investigational Site
    Pavia, 27100, Italy
  • Theravance Biopharma Investigational Site
    Nagoya, Aichi 457-8511, Japan
  • Theravance Biopharma Investigational Site
    Abiko, Chiba 270-1168, Japan
  • Theravance Biopharma Investigational Site
    Sakura, Chiba 285-8741, Japan
  • Theravance Biopharma Investigational Site
    Kurume, Fukuoka 839-0809, Japan
  • Theravance Biopharma Investigational Site
    Ōgaki, Gifu 503-8502, Japan
  • Theravance Biopharma Investigational Site
    Isesaki, Gunma 372-0817, Japan
  • Theravance Biopharma Investigational Site
    Fukuyama-Shi, Hiroshima-ken 720-8520, Japan

Showing the first 100 of 188 sites across 22 countries.

09

References and documents

Study documents

  • Study protocol · May 14, 2020
  • Statistical analysis plan · Oct 20, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03758443
Lead sponsor
Theravance Biopharma
Responsible party
Sponsor
First posted
Nov 29, 2018
Start date
Mar 11, 2019
Primary completion
Oct 20, 2021
Completion
Oct 20, 2021
Results posted
Nov 15, 2022
Last update
Nov 15, 2022

Study contacts

Medical Monitor
study director · Theravance Biopharma

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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