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AzTrials

Ulcerative ColitisPhase 2NCT03558152

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

A Phase 2 study testing UTTR1147A and Vedolizumab in people with Ulcerative Colitis, run by Genentech, Inc. at 72 sites in 16 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

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
UTTR1147A and Vedolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
195 participants
Where
72 sitesin 16 countries
Study dates
26 Oct 2018to 15 Dec 2021
Phase
Phase 2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of UC
  • Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score
  • Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor [TNF] inhibitors [maximum of 2 prior TNF inhibitors]) and/or corticosteroid treatment
  • Use of highly effective contraception as defined by the protocol

Who cannot join

  • History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year; or primary sclerosing cholangitis
  • History of cancer as defined by the protocol
  • Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders (excluding UC)
  • Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC
  • Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis or toxic megacolon within 12 months prior to screening
  • Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
Show all 14Show fewer
  • Current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of the colon
  • History or current evidence of unresectable colonic mucosal dysplasia or history of high-grade colonic mucosal dysplasia
  • Prior treatment with UTTR1147A
  • Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents
  • Prior treatment with rituximab
  • Use of prohibited therapies, as defined by the protocol, prior to randomization
  • Congenital or acquired immune deficiency
  • Evidence or treatment of infections or history of infections, as defined by the protocol

Trial locations and contacts

72 sites in 16 countries.

72 sites in 16 countries

Poland18 sites

  • SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk.

    ?ód?, 90-153

  • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Centrum Endoskopii Zabiegowej

    Bydgoszcz, 85-168

  • Synexus Polska Sp. z o.o. Oddzial w Czestochowie

    Cz?stochowa, 42-202

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gda?sk, 80-382

  • Synexus - Katowice

    Katowice, 40-040

  • Economicus - NZOZ ALL-MEDICUS; Zaklad Gastroenterologii

    Katowice, 40-660

  • ETG Kielce

    Kielce, 25-355

  • Gastromed SPK Niepubliczny Zaklad Opieki Zdrowotnej

    Lublin, 20-582

  • Klimed Marek Klimkiewicz

    Piotrkow Trybunalski, 97-300

  • Synexus Polska Sp. z o.o. Oddzial w Poznaniu

    Późna, 60-702

  • Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa

    Późna, 61-731

  • Endoskopia Sp. z o.o.

    Sopot, 81-756

  • Gastromed Kopon Zmudzinski i

    Toru?, 87-100

  • Centrum Zdrowia MDM

    Warsaw, 00-635

  • Jaroslaw Kierkus Prywatna Prakyka Lekarska

    Warsaw, 00-728

  • Przychodnia EuroMediCare

    Wroc?aw, 50-220

  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

    Wroc?aw, 50-381

  • Melita Medical

    Wroc?aw, 50-449

Other trials in Poland

Ukraine18 sites

  • Regional Municipal Institution Chernivtsi Regional Clinical Hospital; Gastroenterology department

    Chernivtsi, Chernihiv Governorate, 58001

  • Medical Center of LLC Medical Center Family Medicine Clinic; Endoscopy & Gastroenterology

    Dnipr, Polissya Okruha, 49600

  • ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council

    Dnipro, KIEV Governorate, 49005

  • Treatment and Diagnostic Center of LLC MRT Elit

    Kropyvnytskyi, KIEV Governorate, 25005

  • Medical Center of LLC Medical Clinic Blagomed

    Kyiv, KIEV Governorate, 01001

  • Medical Center of Limited Liability Company ?Harmoniya krasy?

    Kyiv, KIEV Governorate, 01135

  • Medical Center of LLC Medical Center Dopomoga Plus

    Kyiv, KIEV Governorate, 02000

  • Medical Center of Edelweiss Medics LLC

    Kyiv, KIEV Governorate, 02002

  • Synexus Affiliate - MC of LLC Medbud-Clinic

    Kyiv, KIEV Governorate, 03037

  • Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"

    Kyiv, KIEV Governorate, 2091

  • Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology

    Ternopil, Katerynoslav Governorate, 46002

  • Transcarpathian Regional Clinical Hospital n.a. A. Novak; Rheumatology Department

    Uzhhorod, 88000

  • City Clinical Hospital #1; Department of Gastroenterology

    Vinnytsia, Kharkiv Governorate, 21029

  • Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov

    Vinnytsia, Podolia Governorate, 21029

  • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

    Zaporizhzhya, Kharkiv Governorate, 69600

  • Medical Center of LLC Diaservis

    Zaporizhzhya, KIEV Governorate, 69076

  • Medical Center of Diaservice LLC; Division of clinical trials conduct, Department #3

    Zaporizhzhya, 69035

  • Medical Centre of PE First Private Clinic

    Zhytomyr, Crimean Regional Governmenta, 10008

Other trials in Ukraine

Serbia7 sites

  • Clinical Hospital Center Zvezdara

    Belgrade, 11000

  • KBC Dr Dragisa Misovic Dedinje

    Belgrade, 11000

  • University Hospital Medical Center Bezanijska kosa

    Belgrade, 11080

  • Clinical Center Kragujevac; Clinic Of Psychiatry

    Kragujevac, 34000

  • General Hospital Vrsac

    Vršac, 26300

  • Clinical Hospital Centre Zemun

    Zemun, 11080

  • General Hospital Djordje Joanovic - Zrenjanin

    Zrenjanin, 23000

Other trials in Serbia

Germany5 sites

  • Gastroenterologische Spezialpraxis-Berlin-Karlshorst

    Berlin, 10318

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307

  • Universitatsklinikum Schleswig-Holstein

    Lübeck, 23538

  • St. Marien Krankenhaus; Med. Klinik

    Ludwigshafen, 67067

  • Universitätsklinikum Ulm; Klinik für Innere Medizin II

    Ulm, 89081

Other trials in Germany

Italy5 sites

  • ASST di Monza - Azienda Ospedaliera San Gerardo; U.O. Farmacia -Settore A - Corpo Posteriore

    Monza, Lombardy, 20900

  • Azienda Ospedaliera Di Padova

    Padova, Veneto, 35128

  • Policlinico Universitario Campus Biomedico Di Roma

    Rome, Lazio, 00128

  • Complesso Integrato Columbus

    Rome, Lazio, 00168

  • Istituto Clinico Humanitas

    Rozzano (MI), Lombardy, 20089

Other trials in Italy

Russia5 sites

  • Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science

    Irkutsk, 664033

  • Rostov State Medical University; Cardiorheumatology Department

    Rostov-on-Don, 344022

  • Saint Martyr Elizabeth City Hospital

    Saint Petersburg, Sankt-Peterburg, 195257

  • North-West State Medical University n.a. I.I. Mechnikov

    Saint Petersburg, 191015

  • Medical University Reaviz

    Samara, 443011

Other trials in Russia

United States2 sites

  • Carolina Digestive Diseases

    Greenville, North Carolina, 27834

  • University of Utah School of Medicine; Gastroenterology Division

    Salt Lake City, Utah, 84132

Other trials in United States

Bulgaria2 sites

  • MHAT Saint Karidad EAD

    Plovdiv, 4000

  • Multiprofile Hospital for Active Treatment Hadji Dimitar OOD

    Sliven, 8800

Other trials in Bulgaria

Greece2 sites

  • Iatriko Palaiou Falirou; Gastrointestinal Department

    Palaió Fáliro, 175 62

  • EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department

    Thessaloniki, 54645

Other trials in Greece

Spain2 sites

  • Hospital de Gran Canaria Dr. Negrin; Servicio de Aparato Digestivo

    Las Palmas de Gran Canaria, LAS Palmas, 35010

  • Hospital Universitario de Torrejon

    Torrejón de Ardoz, Madrid, 28850

Other trials in Spain

Georgia1 site

  • LLC ARENSIA Exploratory Medicine

    Tbilisi, 0112

Other trials in Georgia

Hungary1 site

  • Magyar Honvédség Egészségügyi Központ; Országos Haemophilia Központ

    Budapest, 1134

Other trials in Hungary

Ireland1 site

  • Portiuncula Hospital, Ballinasloe

    Co Galway

Other trials in Ireland

Israel1 site

  • Shaare Zedek Medical Center; Bait Vagan

    Jerusalem, 9103102

Other trials in Israel

Moldova1 site

  • ICS ARENSIA Exploratory Medicine

    Chisinau, MD-2025

Other trials in Moldova

United Kingdom1 site

  • Kings College Hospital

    London, SW9 8RR

Other trials in United Kingdom

About this study

Official title: A Phase II, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and Compared With Vedolizumab in Patients With Moderate to Severe Ulcerative Colitis

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.

Being tested
UTTR1147A, UTTR1147A Placebo, Vedolizumab, Vedolizumab Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • UTTR1147ADrug

    Also called Efmarodocokin alfa, RO7021610, RG7880, IL-22Fc

    UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.

  • UTTR1147A PlaceboDrug

    The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

  • VedolizumabDrug

    Also called Entyvio

    Vedolizumab will be administered IV, as specified in the prescribing information.

  • Vedolizumab PlaceboDrug

    The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Study groups in NCT03558152
Study groupRoleWhat they receive
Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)ExperimentalPart A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Receives: Drug: UTTR1147A; Drug: Vedolizumab Placebo
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)ExperimentalPart A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Receives: Drug: UTTR1147A; Drug: UTTR1147A Placebo; Drug: Vedolizumab Placebo
Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)ExperimentalPart A: UTTR1147A dose level 2 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Receives: Drug: UTTR1147A; Drug: Vedolizumab Placebo
Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)ExperimentalPart A: UTTR1147A dose level 2 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Receives: Drug: UTTR1147A; Drug: UTTR1147A Placebo; Drug: Vedolizumab Placebo
Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)ExperimentalPart A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Receives: Drug: UTTR1147A; Drug: Vedolizumab Placebo
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)ExperimentalPart A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Receives: Drug: UTTR1147A; Drug: UTTR1147A Placebo; Drug: Vedolizumab Placebo
Arm 4: VedolizumabActive comparatorParts A and B: Vedolizumab and UTTR1147A Placebo.
Receives: Drug: UTTR1147A Placebo; Drug: Vedolizumab
Arm 5: PlaceboPlacebo comparatorParts A and B: UTTR1147A Placebo and Vedolizumab Placebo.
Receives: Drug: UTTR1147A Placebo; Drug: Vedolizumab Placebo

What is being measured

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

  1. Percentage of Participants With Clinical Remission at Week 8

    Clinical remission is defined as modified Mayo Clinic Score (mMCS) <= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore <=1 and Centrally read endoscopic score <= 1. Patients were classified as Non-Remitters if Week 8 assessments were missing or patient received permitted/ prohibited Rescue Therapy prior to assessment.

    Measured: 8 weeks

Secondary outcomes (17)

  1. Percentage of Participants With Sustained Remission

    Sustained remission is defined as clinical remission at both Week 8 and Week 30, where clinical remission is defined as modified Mayo Clinic Score (mMCS) <= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore <=1 and Centrally read endoscopic score <= 1.

    Patients were classified as Non-Remitters at Week 8 or at Week 30 if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment

    Measured: At Weeks 8 and 30

  2. Maximum Serum Concentration (Cmax) of UTTR1147A

    Measured: Days 1 - 29, Visit: Day 57

  3. Minimum Serum Concentration (Cmin) of UTTR1147A

    Measured: Days 1 - 29, Visit: Day 57

  4. Percentage of Participants With Clinical Response at Week 8

    Clinical response is defined as achieving clinical remission or as meeting both of the following criteria: A >= 3-point decrease from baseline in modified Mayo Clinic Score (mMCS); A >= 1-point decrease from baseline in rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.

    Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.

    NOTE: An Outcome Measure Description has not been entered.

    Measured: At Week 8

  5. Percentage of Participants With Clinical Response at Week 30

    Clinical response is defined as achieving clinical remission or as meeting both of the following criteria: A >= 3-point decrease from baseline in modified Mayo Clinic Score (mMCS); A >= 1-point decrease from baseline in rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.

    Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.

    Measured: At Week 30

  6. Percentage of Participants With Endoscopic Healing at Week 8

    Endoscopic healing is defined as a Mayo endoscopic subscore <= 1. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.

    Measured: At Week 8

  7. Percentage of Participants With Endoscopic Healing at Week 30

    Endoscopic healing is defined as a Mayo endoscopic subscore <= 1. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.

    Measured: At Week 30

  8. Percentage of Participants With Endoscopic Remission at Week 8

    Endoscopic remission is defined as a Mayo endoscopic subscore of 0. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.

    Measured: At Week 8

  9. Percentage of Participants With Endoscopic Remission at Week 30

    Endoscopic remission is defined as a Mayo endoscopic subscore of 0. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.

    Measured: At Week 30

  10. Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score

    The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.

    Measured: At Week 8

  11. Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score

    The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.

    Measured: At Week 30

  12. Change From Baseline in UC Abdominal Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score

    The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional (abdominal symptoms) domain score ranges from 0-12, with a higher score indicating a worse disease state.

    Measured: At Week 8

  13. Change From Baseline in UC Abdominal Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score

    The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional (abdominal symptoms) domain score ranges from 0-12, with a higher score indicating a worse disease state.

    Measured: At Week 30

  14. Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8

    The IBDQ score is a Total Score summed up from across all 32 questions on the questionnaire. The Total Score range is from 32 to 224 with higher scores representing a better quality of life.

    Measured: At Week 8

  15. Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 30

    The IBDQ score is a Total Score summed up from across all 32 questions on the questionnaire. The Total Score range is from 32 to 224 with higher scores representing a better quality of life.

    Measured: At Week 30

  16. Percentage of Participants With Adverse Events

    Measured: Up to 30 weeks

  17. Percentage of Participants With Presence of Anti-Drug Antibodies (ADA) at Baseline and After Drug Administration

    Measured: Baseline up to 30

Timeline

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

  1. First posted15 Jun 2018
  2. Study start26 Oct 2018
  3. Primary completion15 Dec 2021
  4. Study completion15 Dec 2021

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03558152
Sponsor's protocol ID
GA39925
Other IDs
2017-002350-36, 2017
Status last verified
Mar 2023
First submitted
1 Jun 2018
Last updated
14 Apr 2023
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Publications

  • Danese S, Rothenberg ME, Lim JJ, Ding HT, McBride JM, Chen Y, Dash A, Mar JS, Keir M, Peyrin-Biroulet L, Panes J, Colombel JF, Feagan B, Valentine JF, Schreiber S. A Randomized Phase II Study of Efmarodocokin Alfa, an interleukin-22 Agonist, Versus Vedolizumab in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2025 Jul;23(8):1387-1397. doi: 10.1016/j.cgh.2024.11.013. Epub 2024 Dec 16.

    PubMed 39694207

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing UTTR1147A and Vedolizumab in people with Ulcerative Colitis, run by Genentech, Inc. at 72 sites in 16 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 14 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 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in Poland, Ukraine, Serbia, Germany, Italy and 11 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?

Yes. Results are posted in the registry (first posted 14 Apr 2023). 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?

Percentage of Participants With Clinical Remission at Week 8 (time frame: 8 weeks). 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 NCT03558152, which also lists 1 linked publication.

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 14 Apr 2023.

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