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Ulcerative ColitisPhase 2NCT04857112

Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis

A Phase 2 study testing Low Dose MT-1303, High Dose MT-1303 and MT-1303 in people with Ulcerative Colitis, run by Bausch Health Americas, Inc. at 185 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study will assess the efficacy and safety of oral MT-1303 compared to placebo at 12 weeks as the induction treatment in subjects with active mild to moderate ulcerative colitis (UC), as well as maintenance treatment with open-label MT-1303 for up to 36 weeks. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Low Dose MT-1303, High Dose MT-1303 and MT-1303
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
322 participants
Where
185 sitesin 19 countries
Study dates
29 Sep 2021to 8 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects will be eligible if they are male or female aged between 18 to 75 years at time of consent (inclusive) with normal vital signs and a diagnosis of active mild ulcerative colitis (UC) (modified Mayo Score of 3 or 4) or moderate UC (modified Mayo Score of 5 to 8) confirmed at least 12 weeks prior to randomization by clinical and endoscopic evidence and corroborated by a histopathology report.
  • Subjects must have an endoscopic subscore of ≥2 from and evidence of active UC extending ≥15 cm from the anal verge confirmed by a screening colonoscopy.
  • If subjects are receiving oral or rectal 5-aminosalicylates (5-ASAs) or oral corticosteroids (≤20 mg prednisolone equivalent) for treatment of their UC, they must be on a stable dose for at least 28 days prior to randomization.
  • Subjects who complete the Double-Blind Period of the study who, in the opinion of the Investigator, would benefit from continued treatment, may participate in the Open Label Extension (OLE) Period.

Who cannot join

  • Any of the following: a diagnosis of Crohn's disease, indeterminate colitis, colitis (pseudomembranous, microscopic, or ischemic) or coeliac disease, current or recent (within 12 weeks prior to randomization) evidence of fulminant colitis, proctitis (defined as a rectal inflammation within 15 cm from the anal verge), abdominal abscess, toxic megacolon, bowel obstruction, or bowel perforation; a history or evidence of any colonic resection or subtotal or total colectomy, ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, unresected adenomatous colonic polyps, or colonic mucosal dysplasia.
  • Clinically significant infections (e.g., pneumonia, pyelonephritis, or septicemia) within 4 weeks prior to randomization or previous clinically significant infections requiring hospitalization within 6 months prior to randomization, active or latent tuberculosis, infections of hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or previous shingles outbreak.
  • Active SARS-CoV-2 infection or complications related to COVID-19.
  • A history of, or currently active, primary or secondary immunodeficiency, presence of progressive multifocal leukoencephalopathy (PML), or presence of demyelinating diseases.
  • A history or evidence of two or more failures with biologic treatment for UC.
  • Currently taking any medication for treatment of UC other than oral or rectal 5-ASAs (5-aminosalicylic acids) or oral corticosteroids (≤20 mg prednisolone equivalent)
Show all 22Show fewer
  • Been taking enemas or suppositories (other than stable dose of 5-ASA) for treatment of UC within 2 weeks prior to the Screening Visit.
  • Been taking an unstable dose of probiotics or antidiarrheals 2 weeks prior to the Screening Visit.
  • Had recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure with hospitalization, Class III/IV heart failure, Mobitz Type II 2nd degree or 3rd degree atrioventricular (AV) block, sick sinus syndrome, prolonged QT interval, Wolff Parkinson White or other conduction abnormalities, low heart rate, ongoing treatment with Class I or Class III anti-arrhythmic drugs, heart-rate-lowering calcium-channel blockers, β blockers or with any other drugs which can reduce the heart rate, have known high risk for QT/QTc prolongation, or have clinically significant abnormal findings in 12-lead ECG that the Investigator considers may jeopardize the subject's health.
  • Forced expiratory volume in one second (FEV1) or forced expiratory vital capacity (FVC) <70% of predicted values at screening. For sites where DLCO (diffusing capacity of the lungs for carbon monoxide) will be assessed, the value (mL/min/mmHg) is < 80% of the predicted normal value for age, height, and gender.
  • Macular oedema as assessed by OCT (Optical Coherence Tomography).
  • History of non-response or treatment failure with MT-1303 or other sphingosine 1 phosphate (S1P) receptor modulators.
  • Fecal microbiota transplantation (FMT) within 12 months prior to the Screening Visit.
  • Any of the following laboratory abnormalities:
  • Hemoglobin (Hb) <9.0 g/dL.
  • White blood cell (WBC) count <3.50 × 109/L (<3,500/µL).
  • Neutrophil count <1.50 × 109/L (<1,500/µL).
  • Lymphocyte count <0.80 × 109/L (<800/µL).
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 × the upper limit of normal (ULN).
  • Bilirubin >1.5 x the ULN; subjects with Gilbert's syndrome may be enrolled with total bilirubin up to 5.0 mg/dl.
  • Positive stool tests for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile (C. difficile) during the Screening Period. If subject has a history of recent C. difficile infection (within 60 days prior to Screening Visit), they should not be considered for study enrollment until subject has been treated for C. difficile and is symptom free for at least 14 days prior to the Screening Visit.
  • Any physical or mental conditions which would interfere with the study participation, collection of data, or study completion as determined by the Investigator.

Trial locations and contacts

185 sites in 19 countries.

185 sites in 19 countries

United States22 sites

  • Bausch Site 025

    Chandler, Arizona, 85225

  • Bausch Site 011

    Chicago, Illinois, 60637

  • Bausch Site 014

    El Paso, Texas, 79905

  • Salix Site 002

    Freehold, New Jersey, 07728

  • Bausch Site 020

    Glenview, Illinois, 60026

  • Bausch Site 018

    Houston, Texas, 77030

  • Bausch Site 019

    Houston, Texas, 77030

  • Bausch Site 008

    Lafayette, Louisiana, 70503

  • Salix Site 004

    Los Angeles, California, 90048

  • Bausch Site 013

    Maitland, Florida, 32751

  • Bausch Site 017

    Mentor, Ohio, 44060

  • Bausch Site 022

    Metairie, Louisiana, 70006

  • Bausch Site 024

    Miami, Florida, 33174

  • Salix Site 005

    Miramar, Florida, 33027

  • Bausch Site 021

    Oklahoma City, Oklahoma, 73101

  • Bausch site 026

    Orlando, Florida, 32807

  • Salix Site 003

    Rancho Cucamonga, California, 91730

  • Salix Site 007

    Rialto, California, 92377

  • Salix Site 001

    Shreveport, Louisiana, 71103

  • Salix Site 010

    Snellville, Georgia, 30078

  • Bausch Site 012

    Suffolk, Virginia, 23435

  • Salix Site 006

    Ventura, California, 93003

Other trials in United States

Poland22 sites

  • Bausch Health Site 2320

    Bialystok, 15-322

  • Bausch Health Site 2309

    Bydgoszcz, 85-794

  • Bausch Health Site 2323

    Elblag, 82-300

  • Bausch Health Site 2301

    Krakow, 30-363

  • Bausch Health Site 2306

    Krakow, 31-156

  • Bausch Health Site 2314

    Lodz, 93-357

  • Bausch Health Site 2318

    Nowy Targ, 34-400

  • Bausch Health Site 2305

    Oświęcim, 32-600

  • Bausch Health Site 2316

    Rzeszów, 35-302

  • Bausch Health Site 2304

    Sopot, 81-756

  • Bausch Health Site 2321

    Staszów, 28-200

  • Bausch Health Site 2302

    Szczecin, 71-434

  • Bausch Health Site 2315

    Tychy, 43-100

  • Bausch Health Site 2311

    Warsaw, 00-635

  • Bausch Health Site 2303

    Warsaw, 00-728

  • Bausch Health Site 2322

    Warsaw, 02-665

  • Bausch Health Site 2308

    Warsaw, 03-580

  • Bausch Health Site 2310

    Wierzchosławice, 33-122

  • Bausch Health Site 2313

    Wroclaw, 50-414

  • Bausch Health Site 2317

    Wroclaw, 50-449

  • Bausch Health Site 2307

    Wroclaw, 51-162

  • Bausch Health Site 2319

    Wroclaw, 60-309

Other trials in Poland

Japan21 sites

  • Bausch Health Site 2004

    Chiba, 260-8677

  • Bausch Health Site 2014

    Chiba, 285-8741

  • Bausch Health Site 2011

    Fukuoka, 814-0180

  • Bausch Health Site 2005

    Hiroshima, 734-8551

  • Bausch Health Site 2009

    Hokkaido, 004-0041

  • Bausch Health Site 2019

    Hokkaido, 060-8543

  • Bausch Health Site 2016

    Hyōgo, 663-8501

  • Bausch Health Site 2013

    Iwata, 020-8505

  • Bausch Health Site 2020

    Kagawa, 252-0375

  • Bausch Health Site 2022

    Kamakura, 247-0056

  • Bausch Health Site 2017

    Mie, 510-0016

  • Bausch Health Site 2002

    Miyagi, 983-8520

  • Bausch Health Site 2008

    Nagasaki, 852-8102

  • Bausch Health Site 2006

    Ōita, 870-0823

  • Bausch Health Site 2007

    Saga, 849-8501

  • Bausch Health Site 2023

    Takayama, 506-8550

  • Bausch Health Site 2012

    Tokyo, 108-8642

  • Bausch Health Site 2018

    Tokyo, 113-0034

  • Bausch Health Site 2010

    Tokyo, 169-0073

  • Bausch Health Site 2021

    Tokyo, 181-8611

  • Bausch Health Site 2003

    Tokyo, 192-0032

Other trials in Japan

Russia17 sites

  • Bausch Health Site 2403

    Barnaul, 656015

  • Bausch Health Site 2416

    Chelyabinsk, 454076

  • Bausch Health Site 2417

    Chita, 672090

  • Bausch Health Site 2419

    Moscow, 115419

  • Bausch Health Site 2406

    Moscow, 115516

  • Bausch Health Site 2405

    Nizhny Novgorod, 603140

  • Bausch Health Site 2411

    Novosibirsk, 630005

  • Bausch Health Site 2421

    Orenburg, 460050

  • Bausch Health Site 2413

    Pyatigorsk, 357502

  • Bausch Health Site 2408

    Saint Petersburg, 191015

  • Bausch Health Site 2409

    Saint Petersburg, 191015

  • Bausch Health Site 2415

    Saint Petersburg, 195257

  • Bausch Health Site 2402

    Saint Petersburg, 197110

  • Bausch Health Site 2422

    Samara, 443041

  • Bausch Health Site 2410

    Tomsk, 634050

  • Bausch Health Site 2401

    Velikiy Novgorod, 173008

  • Bausch Health Site 2423

    Yekaterinburg, 620109

Other trials in Russia

Germany15 sites

  • Bausch Health Site 1718

    Augsburg, 86156

  • Bausch Health Site 1705

    Berlin, 10117

  • Bausch Health Site 1716

    Berlin, 14050

  • Bausch Health Site 1717

    Brandenburg, 14770

  • Bausch Health Site 1708

    Cologne, 51103

  • Bausch Health Site 1710

    Dresden, 01307

  • Bausch Health Site 1707

    Frankfurt am Main, 60594

  • Bausch Health Site 1706

    Kiel, 24105

  • Bausch Health Site 1712

    Mainz, 55122

  • Bausch Health Site 1713

    Mannheim, 68167

  • Bausch Health Site 1702

    Nordhausen, 99734

  • Bausch Health Site 1709

    Remscheid, 42589

  • Bausch Health Site 1714

    Rostock, 18057

  • Bausch Health Site 1701

    Tübingen, 72076

  • Bausch Health Site 1703

    Wipperfürth, 51688

Other trials in Germany

Ukraine14 sites

  • Bausch Health Site 2815

    Ivano-Frankivsk, 76008

  • Bausch Health Site 2803

    Kharkiv, 61037

  • Bausch Health Site 2801

    Khmelnytskyi, 29000

  • Bausch Health Site 2804

    Kyiv, 01030

  • Bausch Health Site 2807

    Kyiv, 02091

  • Bausch Health Site 2806

    Kyiv, 04078

  • Bausch Health Site 2814

    Kyiv

  • Bausch Health Site 2811

    Lutsk, 43005

  • Bausch Health Site 2810

    Lviv, 79010

  • Bausch Health Site 2805

    Odesa, 65025

  • Bausch Health Site 2816

    Vinnytsia, 21028

  • Bausch Health Site 2812

    Zaporizhia, 69005

  • Bausch Health Site 2808

    Zaporizhia, 69065

  • Bausch Health Site 2802

    Zhytomyr, 10008

Other trials in Ukraine

South Korea12 sites

  • Bausch Health Site 2109

    Busan, 48108

  • Bausch Health Site 2112

    Daegu, 41404

  • Bausch Health Site 2105

    Daegu, 41944

  • Bausch Health Site 2114

    Daegu, 42601

  • Bausch Health Site 2107

    Seoul, 03080

  • Bausch Health Site 2101

    Seoul, 05278

  • Bausch Health Site 2110

    Seoul, 06351

  • Bausch Health Site 2102

    Seoul, 06591

  • Bausch Health Site 2103

    Seoul, 06973

  • Bausch Health Site 2108

    Seoul

  • Bausch Health Site 2113

    Suwon, 442-723

  • Bausch Health Site 2106

    Wŏnju, 26426

Other trials in South Korea

Bulgaria7 sites

  • Bausch Site 1301

    Sofia, 1233

  • Bausch Site 1304

    Sofia, 1407

  • Bausch Site 1302

    Sofia, 1527

  • Bausch Site 1307

    Sofia, 1680

  • Bausch Site 1303

    Sofia, 1784

  • Bausch Site 1305

    Stara Zagora, 6000

  • Bausch Site 1306

    Varna, 9002

Other trials in Bulgaria

Italy7 sites

  • Bausch Health Site 1906

    Florence, 50134

  • Bausch Health Site 1904

    Messina, 98125

  • Bausch Health Site 1909

    Milan, 20142

  • Bausch Health Site 1901

    Milan, 20157

  • Bausch Health Site 1908

    Monza, 20900

  • Bausch Health Site 1907

    Padova, 35128

  • Bausch Health Site 1903

    Turin, 10128

Other trials in Italy

Czechia6 sites

  • Bausch Health Site 1404

    Brno, 615 00

  • Bausch Health Site 1405

    Hradec Králové, 500 12

  • Bausch Health Site 1403

    Olomouc, 779 00

  • Bausch Health Site 1406

    Pardubice, 532 03

  • Bausch Health Site 1401

    Prague, 130 00

  • Bausch Health Site 1402

    Slaný, 274 01

Other trials in Czechia

Georgia6 sites

  • Bausch Health Site 1602

    Tbilisi, 0131

  • Bausch Health Site 1603

    Tbilisi, 0160

  • Bausch Health Site 1604

    Tbilisi, 0160

  • Bausch Health Site 1605

    Tbilisi, 0160

  • Bausch Health Site 1606

    Tbilisi, 0160

  • Bausch Health Site 1601

    Tbilisi, 0172

Other trials in Georgia

Slovakia6 sites

  • Bausch Health Site 2601

    Banská Bystrica, 975 17

  • Bausch Health Site 2604

    Bratislava, 820 07

  • Bausch Health Site 2605

    Brezno, 97701

  • Bausch Health Site 2603

    Košice, 040 13

  • Bausch Health Site 2602

    Prešov, 080 01

  • Bausch Health Site 2606

    Rimavská Sobota, 979 01

Other trials in Slovakia

Australia5 sites

  • Bausch site 1005

    Adelaide, 5112

  • Bausch site 1001

    Brisbane, 4010

  • Bausch site 1006

    Epping, 3076

  • Bausch site 1002

    South Brisbane, 4101

  • Bausch site 1007

    Woolloongabba, 4102

Other trials in Australia

Moldova5 sites

  • Bausch Health Site 2202

    Chisinau, 2005

  • Bausch Health Site 2205

    Chisinau, MD-2068

  • Bausch Health Site 2201

    Chisinau, MD2025

  • Bausch Health Site 2203

    Chisinau, MD2025

  • Bausch Health Site 2204

    Chisinau, MD2025

Other trials in Moldova

Serbia5 sites

  • Bausch Health Site 2501

    Belgrade, 11 000

  • Bausch Health Site 2502

    Belgrade, 11 000

  • Bausch Health Site 2503

    Belgrade, 11 000

  • Bausch Health Site 2505

    Kragujevac, 34 000

  • Bausch Health Site 2504

    Pančevo, 260 00

Other trials in Serbia

Belarus4 sites

  • Bausch Site 1101

    Homyel, 246029

  • Bausch Site 1104

    Minsk, 220096

  • Bausch Site 1103

    Mogilev, 212018

  • Bausch Site 1105

    Vitebsk, 210002

Other trials in Belarus

Hungary4 sites

  • Bausch Health Site 1805

    Békéscsaba, H-5600

  • Bausch Health Site 1803

    Kistarcsa, H-2143

  • Bausch Health Site 1801

    Mohács, 7700

  • Bausch Health Site 1802

    Székesfehérvár, H-8000

Other trials in Hungary

Taiwan4 sites

  • Bausch Health Site 2703

    Kaohsiung City, 807377

  • Bausch Health Site 2702

    Taichung, 40201

  • Bausch Health Site 2701

    Taichung, 404327

  • Bausch Health Site 2704

    Tainan, 704302

Other trials in Taiwan

Estonia3 sites

  • Bausch Site 1503

    Pärnu, 80010

  • Bausch Site 1501

    Tallinn, 10138

  • Bausch Site 1502

    Tallinn, 10617

Other trials in Estonia

About this study

Official title: A Phase 2, Randomized, Double-Blinded, Placebo Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects With Mild to Moderate Ulcerative Colitis (UC)

The study will assess the efficacy and safety of oral MT-1303 compared to placebo at 12 weeks as the induction treatment in subjects with active mild to moderate ulcerative colitis (UC), as well as maintenance treatment with open-label MT-1303 for up to 36 weeks.

Read the detailed description

This is a Phase 2, randomized, double-blinded, placebo-controlled 3-arm, multi-center, parallel-group study with an open-label extension (OLE) period. The study includes a Screening Period (of up to 28 days) and a 12-week Double-Blind Period (Day 1 through Day 85) for all subjects. Subjects completing the Double-Blind Period through Day 85 will be provided the opportunity to continue in the OLE Period of the study to receive treatment through approximately one year. Subjects who do not participate in the OLE Period will be followed for 84 days in a Safety Follow-up Period.

Being tested
Low Dose MT-1303, High Dose MT-1303, Placebo, MT-1303
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • Low Dose MT-1303Drug

    Also called Amiselimod

    MT-1303 loading dose of 0.4 mg once daily (QD) (Day 1-14) then maintenance dose of 0.2 mg QD (Day 15-85)

  • High Dose MT-1303Drug

    Also called Amiselimod

    MT-1303 loading dose of 0.8 mg QD (Day 1-14) then maintenance dose of 0.4 mg QD (Day 15-85)

  • PlaceboDrug

    Also called Amiselimod

    Matching placebo, QD (Day 1-85)

  • MT-1303Drug

    Also called Amiselimod

    0.4 mg MT-1303 QD for 36 weeks for those participants who continue on to the OLE period from the double-blind portion of the clinical study

Study groups in NCT04857112
Study groupRoleWhat they receive
Low DoseExperimentalMT-1303 loading dose of 0.4 mg once daily (QD) (Day 1-14) then maintenance dose of 0.2 mg QD (Day 15-85)
Receives: Drug: Low Dose MT-1303
High DoseExperimentalMT-1303 loading dose of 0.8 mg QD (Day 1-14) then maintenance dose of 0.4 mg QD (Day 15-85)
Receives: Drug: High Dose MT-1303
PlaceboPlacebo comparatorMatching placebo, QD (Day 1-85)
Receives: Drug: Placebo
Open Label Extension PeriodOther0.4 mg MT-1303 QD for 36 weeks for those participants who continue on to the OLE period from the double-blind portion of the clinical study
Receives: Drug: MT-1303

What is being measured

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

  1. Change from Baseline in the modified Mayo Score at Day 85

    The modified Mayo Score for ulcerative colitis disease activity provides an assessment of disease severity and can be used to monitor subjects during therapy. Scoring is accomplished by summation of subscores for endoscopic findings, stool frequency, and rectal bleeding, with higher scores indicating worse severity. Each subscore ranges from 0 to 3. The modified Mayo Score is defined as the sum of the endoscopy findings subscore + stool frequency subscore + rectal bleeding subscore, with a range from 0 to 9.

    Measured: Baseline to Day 85

Secondary outcomes (3)

  1. The proportion of subjects with endoscopic improvement at Day 85

    The Mayo endoscopic subscore ranges from 0 to 3, with higher scores indicating worse severity. Endoscopic improvement is a Mayo endoscopic subscore of ≤1.

    Measured: Baseline to Day 85

  2. The change from Baseline in the 2-component Mayo Score at Day 85.

    2-component Mayo scoring is accomplished by summation of subscores for endoscopic findings and rectal bleeding, with higher scores indicating worse severity. Each subscore ranges from 0 to 3. The 2-component Mayo Score is the sum of the rectal bleeding plus endoscopic subscores, with a range from 0 to 6.

    Measured: Baseline to Day 85

  3. The proportion of subjects with clinical remission at Day 85 based on the modified Mayo Score

    The modified Mayo Score for ulcerative colitis disease activity provides an assessment of disease severity and can be used to monitor subjects during therapy. Scoring is accomplished by summation of subscores for endoscopic findings, stool frequency, and rectal bleeding, with higher scores indicating worse severity. Each subscore ranges from 0 to 3.

    Remission is defined as follows:

    • Endoscopy subscore of ≤1 (excludes friability); and
    • Rectal bleeding subscore of 0; and
    • At least one-point decrease in stool frequency subscore from Baseline to achieve a stool frequency subscore of ≤1.

    Measured: Baseline to Day 85

Timeline

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

  1. First posted23 Apr 2021
  2. Study start29 Sep 2021
  3. Primary completion3 Sep 2024
  4. Study completion8 Nov 2024

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
322 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04857112
Sponsor's protocol ID
AMUC-2023
Status last verified
Sep 2025
First submitted
19 Apr 2021
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low Dose MT-1303, High Dose MT-1303 and MT-1303 in people with Ulcerative Colitis, run by Bausch Health Americas, Inc. at 185 sites in 19 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 4 inclusion and 22 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: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 185 sites in United States, Poland, Japan, Russia, Germany and 14 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from Baseline in the modified Mayo Score at Day 85 (time frame: Baseline to Day 85). 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 NCT04857112.

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 9 Sep 2025.

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