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Ulcerative Colitis (UC)Phase 2/3NCT03920254

TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study

A Phase 2/3 study testing TD-1473 Dose A, TD-1473 Dose B and TD-1473 Dose C in people with Ulcerative Colitis (UC), run by Theravance Biopharma at 184 sites in 22 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

A 3-Year Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis who have participated in the Maintenance Study of Protocol 0157 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis (UC)
What is being tested?
TD-1473 Dose A, TD-1473 Dose B and TD-1473 Dose C
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
184 sitesin 22 countries
Study dates
23 Jul 2020to 27 Oct 2021
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be eligible for the study, subjects are required to enter the LTS Study within 14 days of exiting the Maintenance Study of Protocol 0157 and must meet all the following criteria:
  • Capable of providing informed consent, which must be obtained prior to any study related procedures.
  • One of the following:
  • Those who demonstrated persistent loss of response (no improvement 8 weeks after meeting loss of response criteria) OR
  • Two Clinical Flares after an episode of loss of response during the Maintenance Study OR
  • Those who have completed the Maintenance Study and confirmation of clinical remission status results are available
Show all 9Show fewer
  • During the study and for 7 days after receiving the last dose of the study drug, females of childbearing potential or men capable of fathering children must agree to use highly effective birth control measures (failure rate <1% when used consistently and correctly)) or agree to abstain from sexual intercourse. Females of childbearing potential must test negative for pregnancy at Day 1
  • All male subjects must agree to refrain from semen donation during the study and for 7 days after the last dose of study drug.
  • Must be able and willing to adhere to the study visit schedule and comply with other study requirements.

Who cannot join

  • 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
  • Has been diagnosed during Protocol 0157 with Crohn's disease, other colitis conditions or the subject has a current or past diagnosis of a fistula or abdominal abscess
  • Has endoscopic findings during Protocol 0157 of colitis-associated colonic dysplasia (with the exception of subjects with non-colitis associated spontaneous adenomas that have been completely resected)
  • Has clinically significant abnormalities in laboratory evaluations
  • Additional exclusion criteria apply

Trial locations and contacts

184 sites in 22 countries.

184 sites in 22 countries

United States36 sites

  • Theravance Biopharma Investigational Site

    Atlanta, Georgia, 30342

  • Theravance Biopharma Investigational Site

    Aventura, Florida, 33180

  • Theravance Biopharma Investigational Site

    Baltimore, Maryland, 21201

  • Theravance Biopharma Investigational Site

    Charlotte, North Carolina, 28215

  • Theravance Biopharma Investigational Site

    Chula Vista, California, 91911

  • Theravance Biopharma Investigational Site

    Clearwater, Florida, 33756

  • Theravance Biopharma Investigational Site

    Colorado Springs, Colorado, 80920

  • Theravance Biopharma Investigational Site

    Garland, Texas, 75044

  • Theravance Biopharma Investigational Site

    Gastonia, North Carolina, 28054

  • Theravance Biopharma Investigational Site

    Greenville, North Carolina, 27834-3761

  • Theravance Biopharma Investigational Site

    Greenville, South Carolina, 29615

  • Theravance Biopharma Investigational Site

    Houston, Texas, 77002

  • Theravance Biopharma Investigational Site

    Idaho Falls, Idaho, 83404

  • Theravance Biopharma Investigational Site

    Kansas City, Kansas, 66160

  • Theravance Biopharma Investigational Site

    Kansas City, Missouri, 64131

  • Theravance Biopharma Investigational Site

    Lancaster, California, 93534

  • Theravance Biopharma Investigational Site

    Largo, Florida, 33777

  • Theravance Biopharma Investigational Site

    Las Vegas, Nevada, 89123

  • Theravance Biopharma Investigational Site

    Louisville, Kentucky, 40202

  • Theravance Biopharma Investigational Site

    Miami, Florida, 33135

  • Theravance Biopharma Investigational Site

    Miami, Florida, 33155

  • Theravance Biopharma Investigational Site

    Monroe, Louisiana, 71201

  • Theravance Biopharma Investigational Site

    Nashville, Tennessee, 27212

  • Theravance Biopharma Investigational Site

    New Port Richey, Florida, 34653

  • Theravance Biopharma Investigational Site

    New Smyrna Beach, Florida, 32168

  • Theravance Biopharma Investigational Site

    Orange, California, 92866

  • Theravance Biopharma Investigational Site

    Orlando, Florida, 32803

  • Theravance Biopharma Investigational Site

    Pembroke Pines, Florida, 33024

  • Theravance Biopharma Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • Theravance Biopharma Investigational Site

    Rochester, Minnesota, 55905

  • Theravance Biopharma Investigational Site

    Rock Hill, South Carolina, 29732

  • Theravance Biopharma Investigational Site

    San Antonio, Texas, 78215

  • Theravance Biopharma Investigational Site

    Smithfield, Pennsylvania, 15478

  • Theravance Biopharma Investigational Site

    Suwanee, Georgia, 30024

  • Theravance Biopharma Investigational Site

    Troy, Michigan, 48098

  • Theravance Biopharma Investigational Site

    Wyoming, Michigan, 48519

Other trials in United States

Japan23 sites

  • Theravance Biopharma Investigational Site

    Abiko, Chiba, 270-1168

  • Theravance Biopharma Investigational Site

    Ageo Shi, Saitama, 362-0075

  • Theravance Biopharma Investigational Site

    Chiba, 260-0852

  • Theravance Biopharma Investigational Site

    Fujiidera, Osaka, 583-0027

  • Theravance Biopharma Investigational Site

    Fukuoka, 814-0180

  • Theravance Biopharma Investigational Site

    Hatsukaichi, Hiroshima, 738-8503

  • Theravance Biopharma Investigational Site

    Hiroshima, Hiroshima, 720-8520

  • Theravance Biopharma Investigational Site

    Isesaki, Gunma, 372-0817

  • Theravance Biopharma Investigational Site

    Izumiōtsu, Osaka, 595-0027

  • Theravance Biopharma Investigational Site

    Kawasaki, Kanagawa, 211-8533

  • Theravance Biopharma Investigational Site

    Kumamoto, 860-0004

  • Theravance Biopharma Investigational Site

    Kurobe-shi, Toyama, 938-8502

  • Theravance Biopharma Investigational Site

    Kurume, Fukuoka, 839-0809

  • Theravance Biopharma Investigational Site

    Nagoya, Aichi-ken, 457-8511

  • Theravance Biopharma Investigational Site

    Ōgaki, Gifu, 503-8502

  • Theravance Biopharma Investigational Site

    Ōita, Oita Prefecture, 870-0033

  • Theravance Biopharma Investigational Site

    Sakura, Chiba, 285-8741

  • Theravance Biopharma Investigational Site

    Sendai, Miyagi, 981-3213

  • Theravance Biopharma Investigational Site

    Suwa, Nagano, 392-8510

  • Theravance Biopharma Investigational Site

    Tokorozawa, Saitama, 359-1114

  • Theravance Biopharma Investigational Site

    Tokyo, 135-8577

  • Theravance Biopharma Investigational Site

    Tokyo, 136-0075

  • Theravance Biopharma Investigational Site

    Tokyo, 152-8902

Other trials in Japan

Poland20 sites

  • Theravance Biopharma Investigational Site

    Krakow, Lesser Poland Voivodeship, 31-501

  • Theravance Biopharma Investigational Site

    Ksawerów, Łódź Voivodeship, 95-054

  • Theravance Biopharma Investigational Site

    Lodz, Łódź Voivodeship, 90-302

  • Theravance Biopharma Investigational Site

    Lodz, Łódź Voivodeship, 91-034

  • Theravance Biopharma Investigational Site

    Piaseczno, Masovian Voivodeship, 05-500

  • Theravance Biopharma Investigational Site

    Poznan, Greater Poland Voivodeship, 60-369

  • Theravance Biopharma Investigational Site

    Poznan, Greater Poland Voivodeship, 61-113

  • Theravance Biopharma Investigational Site

    Sopot, Pomeranian Voivodeship, 81-756

  • Theravance Biopharma Investigational Site

    Świętokrzyskie, 28-200

  • Theravance Biopharma Investigational Site

    Szczecin, West Pomeranian Voivodeship, 71-434

  • Theravance Biopharma Investigational Site

    Szczecin, West Pomeranian Voivodeship, 71-685

  • Theravance Biopharma Investigational Site

    Torun, Kuyavian-Pomeranian Voivodeship, 71-685

  • Theravance Biopharma Investigational Site

    Tychy, Silesian Voivodeship, 43-100

  • Theravance Biopharma Investigational Site

    Warsaw, Masovian Voivodeship, 00-635

  • Theravance Biopharma Investigational Site

    Warsaw, Masovian Voivodeship, 00-728

  • Theravance Biopharma Investigational Site

    Warsaw, Masovian Voivodeship, 02-653

  • Theravance Biopharma Investigational Site

    Warsaw, Masovian Voivodeship, 03-580

  • Theravance Biopharma Investigational Site

    Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800

  • Theravance Biopharma Investigational Site

    Wroclaw, Lower Silesian Voivodeship, 53-333

  • Theravance Biopharma Investigational Site

    Wroclaw, Lower Silesian Voivodeship, 54-416

Other trials in Poland

Ukraine17 sites

  • Theravance Biopharma Investigational Site

    Chernivtsi, 58001

  • Theravance Biopharma Investigational Site

    Kharkiv, 61037

  • Theravance Biopharma Investigational Site

    Kiev, KIEV CITY, 04107

  • Theravance Biopharma Investigational Site

    Kremenchuk, Poltava Oblast, 39617

  • Theravance Biopharma Investigational Site

    Kyiv, Kyiv City, 01030

  • Theravance Biopharma Investigational Site

    Kyiv, Kyiv City, 4107

  • Theravance Biopharma Investigational Site #2

    Lviv, 79010

  • Theravance Biopharma Investigational Site

    Lviv, 79010

  • Theravance Biopharma Investigational Site

    Ternopil, 46001

  • Theravance Biopharma Investigational Site

    Uzhhorod, Transcarpathian, 88000

  • Theravance Biopharma Investigational Site

    Uzhhorod, Zakarpattia Oblast, 88009

  • Theravance Biopharma Investigational Site #2

    Vinnytsia, Vinnytsya, 20129

  • Theravance Biopharma Investigational Site

    Vinnytsia, Vinnytsya, 21005

  • Theravance Biopharma Investigational Site

    Vinnytsia, Vinnytsya, 21029

  • Theravance Biopharma Investigational Site

    Vinnytsia, 21018

  • Theravance Biopharma Investigational Site

    Zaporizhzhya, 69096

  • Theravance Biopharma Investigational Site

    Zaporizhzhya, 69600

Other trials in Ukraine

Bulgaria13 sites

  • Theravance Biopharma Investigational Site #2

    Pleven, 5800

  • Theravance Biopharma Investigational Site

    Pleven, 5800

  • Theravance Biopharma Investigational Site

    Plovdiv, 4002

  • Theravance Biopharma Investigational Site

    Plovdiv, 4004

  • Theravance Biopharma Investigational Site

    Rousse, 7005

  • Theravance Biopharma Investigational Site

    Sliven, 8800

  • Theravance Biopharma Investigational Site

    Sofia, Sofia, 1303

  • Theravance Biopharma Investigational Site

    Sofia, Sofia, 1527

  • Theravance Biopharma Investigational Site

    Sofia, Sofia, 1784

  • Theravance Biopharma Investigational Site

    Sofia, 1712

  • Theravance Biopharma Investigational Site

    Stara Zagora, 6000

  • Theravance Biopharma Investigational Site

    Stara Zagora, 6001

  • Theravance Biopharma Investigational Site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

France9 sites

  • Theravance Biopharma Investigational Site

    Amiens, Picardie, 80054

  • Theravance Biopharma Investigational Site

    Lille, Hauts-de-France, 59037

  • Theravance Biopharma Investigational Site

    Montpellier, Languedoc-roussillon, 34295

  • Theravance Biopharma Investigational Site

    Nantes, Pays de la Loire Region, 44000

  • Theravance Biopharma Investigational Site

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • Theravance Biopharma Investigational Site

    Reims, Champagne-ardenne, 51092

  • Theravance Biopharma Investigational Site

    Saint-Etienne, Auvergne-Rhône-Alpes, 42055

  • Theravance Biopharma Investigational Site

    Toulouse, Midi-pyrenees, 31059

  • Theravance Biopharma Investigational Site

    Vandœuvre-lès-Nancy, Limousin, 54500

Other trials in France

Portugal8 sites

  • Theravance Biopharma Investigational Site

    Coimbra, 3000-075

  • Theravance Biopharma Investigational Site

    Guimarães, 4835-044

  • Theravance Biopharma Investigational Site

    Leiria, 2410-197

  • Theravance Biopharma Investigational Site

    Lisbon, 1349-019

  • Theravance Biopharma Investigational Site

    Santa Maria da Feira, 4520-211

  • Theravance Biopharma Investigational Site

    Senhora da Hora, 4454-513

  • Theravance Biopharma Investigational Site

    Viana do Castelo, 4901-858

  • Theravance Biopharma Investigational Site

    Vila Nova de Gaia, 4434502

Other trials in Portugal

Israel7 sites

  • Theravance Biopharma Investigational Site

    Haifa, 31048

  • Theravance Biopharma Investigational Site

    Holon, 5822012

  • Theravance Biopharma Investigational Site

    Jerusalem, 9362410

  • Theravance Biopharma Investigational Site

    Nahariya, 2210001

  • Theravance Biopharma Investigational Site

    Petah Tikva, 4941492

  • Theravance Biopharma Investigational Site

    Rehovot, 7661041

  • Theravance Biopharma Investigational Site

    Tsrifin, Rehoboth, 7030000

Other trials in Israel

South Korea7 sites

  • Theravance Biopharma Investigational Site

    Daegu, 42415

  • Theravance Biopharma Investigational Site

    Seoul, 03722

  • Theravance Biopharma Investigational Site

    Seoul, 06351

  • Theravance Biopharma Investigational Site

    Seoul, 130702

  • Theravance Biopharma Investigational Site

    Seoul, 5505

  • Theravance Biopharma Investigational Site

    Suwon, Gyeonggi-do, 16247

  • Theravance Biopharma Investigational Site

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

Serbia6 sites

  • Theravance Biopharma Investigational Site

    Belgrade, 11000

  • Theravance Biopharma Investigational Site

    Belgrade, 11080

  • Theravance Biopharma Investigational Site

    Kragujevac, 34000

  • Theravance Biopharma Investigational Site

    Niš, 18000

  • Theravance Biopharma Investigational Site

    Subotica, 24000

  • Theravance Biopharma Investigational Site

    Zrenjanin, 23000

Other trials in Serbia

Hungary5 sites

  • Theravance Biopharma Investigational Site

    Budapest, 1088

  • Theravance Biopharma Investigational Site

    Budapest, 1136

  • Theravance Biopharma Investigational Site

    Debrecen, Hajdú-Bihar, 4032

  • Theravance Biopharma Investigational Site

    Székesfehérvár, Fejér, 8000

  • Theravance Biopharma Investigational Site

    Szekszárd, Tolna County, 7100

Other trials in Hungary

Australia4 sites

  • Theravance Biopharma Investigational Site

    Malvern, Victoria, 3144

  • Theravance Biopharma Investigational Site

    Murdoch, Western Australia, 6150

  • Theravance Biopharma Investigational Site

    South Brisbane, Queensland, 4101

  • Theravance Biopharma Investigational Site

    Woolloongabba, Queensland, 4102

Other trials in Australia

Germany4 sites

  • Theravance Biopharma Investigational Site

    Berlin, 10117

  • Theravance Biopharma Investigational Site

    Berlin, 13353

  • Theravance Biopharma Investigational Site

    Heidelberg, Baden-Wurttemberg

  • Theravance Biopharma Investigational Site

    Kiel, Schleswig-Holstein, 24105

Other trials in Germany

Greece4 sites

  • Theravance Biopharma Investigational Site

    Athens, Attica, 115 27

  • Theravance Biopharma Investigational Site #2

    Athens, Attica, 11527

  • Theravance Biopharma Investigational Site

    Heraklion, Crete, 71110

  • Theravance Biopharma Investigational Site

    Patra, Peloponnese, 265 04

Other trials in Greece

Spain4 sites

  • Theravance Biopharma Investigational Site

    Barcelona, 08022

  • Theravance Biopharma Investigational Site

    Madrid, 28006

  • Theravance Biopharma Investigational Site

    Seville, 41013

  • Theravance Biopharma Investigational Site

    Valencia, 46010

Other trials in Spain

Taiwan4 sites

  • Theravance Biopharma Investigational Site

    Kaohsiung City, Kaohsiung City, 83301

  • Theravance Biopharma Investigational Site

    Taichung, 40210

  • Theravance Biopharma Investigational Site

    Tainan, 71004

  • Theravance Biopharma Investigational Site

    Taipei, 116

Other trials in Taiwan

Georgia3 sites

  • Theravance Biopharma Investigational Site

    Batumi, 6010

  • Theravance Biopharma Investigational Site

    Tbilisi, 0114

  • Theravance Biopharma Investigational Site

    Tbilisi, 0159

Other trials in Georgia

Italy3 sites

  • Theravance Biopharma Investigational Site

    Catanzaro, 88100

  • Theravance Biopharma Investigational Site

    Pavia, 27100

  • Theravance Biopharma Investigational Site

    Rozzano, Milano, 20089

Other trials in Italy

Slovakia3 sites

  • Theravance Biopharma Investigational Site

    Nitra, 949 01

  • Theravance Biopharma Investigational Site

    Prešov, Prešovsky, 080 01

  • Theravance Biopharma Investigational Site

    Šahy, 936 01

Other trials in Slovakia

Romania2 sites

  • Theravance Biopharma Investigational Site

    Bucharest, 02025

  • Theravance Biopharma Investigational Site

    Timișoara, Timiș County, 300002

Other trials in Romania

Canada1 site

  • Theravance Biopharma Investigational Site

    Kingston, Ontario, K7L 5G2

Other trials in Canada

South Africa1 site

  • Theravance Biopharma Investigational Site

    Johannesburg, Gauteng, 2196

Other trials in South Africa

About this study

Official title: A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects With Ulcerative Colitis (UC)

A 3-Year Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis who have participated in the Maintenance Study of Protocol 0157

Read the detailed description

This is a multi-center, long-term safety study to evaluate the safety and tolerability of TD-1473 for up to 156 weeks (3 years) + 4 week follow-up in subjects with moderate to severe UC exiting the preceding Maintenance Study of Protocol 0157 (NCT03758443).

Being tested
TD-1473 Dose A, TD-1473 Dose B, TD-1473 Dose C
Keywords
TD-1473, Janus kinase inhibitor, JAK inhibitor, Inflammatory Bowel Disease, IBD, Ulcerative colitis, UC, Intestinal restriction, Gut-selective
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TD-1473 Dose ADrug

    See Arm description

  • TD-1473 Dose BDrug

    See Arm description

  • TD-1473 Dose CDrug

    See Arm description

Study groups in NCT03920254
Study groupRoleWhat they receive
Active Treatment TD-1473 with Dose AExperimentalOral daily dose of TD-1473 for up to 156 weeks
Receives: Drug: TD-1473 Dose A
Active Treatment TD-1473 with Dose BExperimentalOral daily dose of TD-1473 for up to 156 weeks
Receives: Drug: TD-1473 Dose B
Active Treatment TD-1473 with Dose CExperimentalOral daily dose of TD-1473 for up to 156 weeks
Receives: Drug: TD-1473 Dose C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

    A TEAE was defined as any AE with a recorded start date on or after the date of the first dose of study drug up through 4 weeks after the last dose of study drug. Any clinically significant changes in laboratory safety tests, electrocardiograms (ECGs) and vital signs, were also recorded as TEAEs.

    Measured: Day 1 up to 4 weeks after last dose of study drug (median treatment duration was: TD-1473 20 mg - 142 days; TD-1473 80 mg - 180.0 days; TD-1473 200 mg - 158 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2019
  2. Study start23 Jul 2020
  3. Primary completion27 Oct 2021
  4. Study completion27 Oct 2021

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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Long Term Safety (LTS)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03920254
Sponsor's protocol ID
0164
Other IDs
2018-002135-19, 2018
Status last verified
Oct 2022
First submitted
28 Mar 2019
Last updated
2 Nov 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing TD-1473 Dose A, TD-1473 Dose B and TD-1473 Dose C in people with Ulcerative Colitis (UC), run by Theravance Biopharma at 184 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 184 sites in United States, Japan, Poland, Ukraine, Bulgaria and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) (time frame: Day 1 up to 4 weeks after last dose of study drug (median treatment duration was: TD-1473 20 mg - 142 days; TD-1473 80 mg - 180.0 days; TD-1473 200 mg - 158 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03920254.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.

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