AzTrials
AzTrials

Ulcerative ColitisPhase 2NCT06598943

A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis

A Phase 2 study testing Eltrekibart and Mirikizumab in people with Ulcerative Colitis and Ulcerative Colitis Chronic, run by Eli Lilly and Company at 207 sites in 21 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Eltrekibart and Mirikizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
143 participants
Where
207 sitesin 21 countries
Study dates
10 Oct 2024to Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Have had an established diagnosis of UC of ≥3 months in duration before baseline.
  • Have moderately to severely active UC as assessed by the UC disease activity score.
  • Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators).
  • Are on a stable dose of certain oral UC medications (including corticosteroids).
  • Must meet contraception requirements.

Who cannot join

  • Have received anti-interleukin (IL)-23p19 or anti-IL-12p40 antibodies in the past.
  • Have experienced a thrombotic event within 24 weeks before baseline.
  • Have a current diagnosis of Crohn's Disease or certain other inflammatory gastrointestinal diseases.
  • Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study.
  • Have a history of certain adenomas, dysplasia's, or malignancies.

Trial locations and contacts

207 sites in 21 countries.

207 sites in 21 countries

United States46 sites

  • Inquest Clinical Research

    Baytown, Texas, 77521

  • Ellipsis Research Group

    Brooklyn, New York, 11215

  • AZ Gastro Care - Chandler

    Chandler, Arizona, 85225

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Northwestern University

    Chicago, Illinois, 60611

  • Erick Alayo Medical Corp/Gastro SB Clinic

    Chula Vista, California, 91910

  • GCGA Physicians, LLC dba / Gastro Health Research

    Cincinnati, Ohio, 45219

  • Novum Research, LLC

    Clermont, Florida, 34711

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907-6262

  • Southern California GI and Liver Centers (SCLC)

    Coronado, California, 92118

  • I.V.A.M. Clinical & Investigational Center, LLC

    Doral, Florida, 33126

  • DHR Health Gastroenterology - Edinburg

    Edinburg, Texas, 78539

  • Valley View Research

    Garden Grove, California, 92845

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518-3602

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Intergrity Research

    Houston, Texas, 77043

  • Smart Medical Research - Jackson Heights

    Jackson Heights, New York, 11372

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • Om Research, LLC

    Lancaster, California, 93534

  • NexGen Research

    Lima, Ohio, 45801

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72205

  • Preferred Research Partners

    Little Rock, Arkansas, 72211

  • United Medical Doctors

    Los Alamitos, California, 90720-3433

  • Clinical Trials Management, LLC

    Metairie, Louisiana, 70006

  • Well Pharma Medical Research Corp.

    Miami, Florida, 33173

  • Reserka

    Miami, Florida, 33176

  • Pioneer Clinical Research NY

    New York, New York, 10012-3645

  • Avicenna Clinical Research - SW Gastroenterology

    Oak Lawn, Illinois, 60453-3754

  • Care Access-Ogden

    Ogden, Utah, 84403

  • Advanced Research Institute - South Ogden

    Ogden, Utah, 84405

  • Clinnova Research

    Orange, California, 92868-4402

  • Digestive Disease Consultants DDCJAX

    Orange Park, Florida, 32073-4752

  • Orlando Health Digestive Health Institute

    Orlando, Florida, 32803-1248

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Prospective Research Innovations

    Rancho Cucamonga, California, 91730-4850

  • Gastroenterology Research of San Antonio

    San Antonio, Texas, 78229

  • University of Washington School Medicine

    Seattle, Washington, 98195

  • Nodal Medical Center

    Tampa, Florida, 33607

  • Research Bay,Inc.

    Tampa, Florida, 33607

  • GCP Clinical Research, LLC

    Tampa, Florida, 33609

  • International Center for Research LLC

    Tampa, Florida, 33614

  • Clinical Trials Management Services, LLC

    Thousand Oaks, California, 91360

  • Tyler Research Institute

    Tyler, Texas, 75701

  • Digestive Disease Medicine of Central New York

    Utica, New York, 13502

  • Om Research LLC

    Victorville, California, 92395

  • Gastroenterology Associates of Western Michigan, P.L.C.

    Wyoming, Michigan, 49519

Other trials in United States

Japan34 sites

  • Chiba University Hospital

    Chiba, 260-8677

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, 818-8502

  • Saiseikai Fukuoka General Hospital

    Fukuoak, 810-0001

  • Hachinohe City Hospital

    Hachinohe-shi, 031-8555

  • National Hospital Organization Hirosaki General Medical Center

    Hirosaki, 036-8545

  • Hiroshima City North Medical Center Asa Citizens Hospital

    Hiroshima, 731-0293

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Tokai University Hospital

    Isehara, 259-1193

  • Isesaki Municipal Hospital

    Isesaki-shi, 372-0817

  • Kagoshima IBD Gastroenterology Clinic

    Kagoshima, 892-0843

  • National Hospital Organization Kanazawa Medical Center

    Kanazawa, 920-8650

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa, 277-0871

  • JCHO Kyushu Hospital

    Kitakyushu-Shi, 806 8501

  • Yamanashi Prefectural Central Hospital

    Kofu, 400-8506

  • Hoshi General Hospital Foundation

    Koriyama-shi, 963-8801

  • Showa University Koto Toyosu Hospital

    Kōtoku, 135 8577

  • Our Lady of the Snow St. Mary's Hospital

    Kurume-shi, 830 8543

  • Kitasato University Kitasato Institute Hospital

    Minatoku, 108 8642

  • Kyorin University Hospital

    Mitaka, 181-8611

  • Iwate Medical University Hospital

    Morioka, 020-8505

  • Nara Prefecture General Medical Center

    Nara, 630-8054

  • Hyogo College of Medicine

    Nishinomiya, 663-8501

  • Oita Red Cross Hospital

    Ōita, 870-0033

  • Infusion Clinic

    Osaka, 530-0011

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033

  • Tokushukai Sapporo Tokushukai Hospital

    Sapporo, 40041

  • Sapporo IBD Clinic

    Sapporo Shi Chuo Ku, 064-0919

  • NTT Medical Center Tokyo

    Shinagawa-KU, 141-8625

  • JHCO Tokyo Yamate Medical Center

    Shinjuku-ku, 169-0073

  • Tokyo Metro Bokutoh Hospital

    Sumida-ku, 130-8575

  • National Hospital Organization Shizuoka Medical Center

    Sunto-gun, 411-8611

  • Toyama University Hospital

    Toyama, 930-0194

  • Mie University Hospital

    Tsu, 514-8507

  • Matsushima Hospital

    Yokohama, 220 0041

Other trials in Japan

Italy19 sites

  • IRCCS - AOU di Bologna

    Bologna, 40138

  • Fondazione Poliambulanza

    Brescia, 25124

  • AST Pesaro Urbino - Presidio Ospedaliero Santa Croce

    Fano, 61032

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • A.O.U. Policlinico G. Martino

    Gazzi - Messina, 98125

  • Ospedale S. Paolo

    Milan, 20142

  • Azienda Ospedaliero Universitaria

    Modena, 41124

  • Università di Cagliari - Presidio Policlinico Monserrato

    Monserrato, 09042

  • Azienda Ospedale Università di Padova

    Padova, 35128

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Policlinico Tor Vergata

    Roma, 00133

  • Ospedale Sandro Pertini

    Roma, 157

  • Policlinico Universitario Campus Bio-Medico

    Rome, 00128

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • IRCCS Policlinico San Donato

    San Donato Milanese, 20097

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

  • IRCCS Ospedale San Raffaele

    Segrate, 20132

  • A.O.U. Citta' della Salute e della Scienza di Torino

    Torino, 10126

  • SC Farmacia AO Ordine Mauriziano

    Torino, 10128

Other trials in Italy

Poland18 sites

  • ManerMed Sp z o.o. Centrum Medyczne ,Medis

    Bydgoszcz, 85-229

  • Centrum Medyczne Kermed Renata Bojata-Bronisz i Ewa Kowalińska Sp.j.

    Bydgoszcz, 85-231

  • Centrum Medyczne Plejady Magdalena Celińska-Löwenhoff, Michał Żołnowski sp.k

    Krakow, 30-363

  • Centrum Nowoczesnych Terapii "Dobry Lekarz" sp. z o. o.

    Krakow, 31-011

  • Topolowa Medicenter Ryszawa & Wspólnicy Sp.j.

    Krakow, 31-506

  • Ip Clinic Sp. Z O. O.

    Lodz, 90-752

  • Med-GASTR SP. Z O.O., SP.K.

    Lodz, 91 034

  • Medrise Sp. z o.o

    Lublin, 20-582

  • Twoja Przychodnia Opolskie Centrum Medyczne

    Opole, 45 819

  • Twoja Przychodnia Pcm

    Poznan, 60-324

  • Endoskopia Sp. z.o.o.

    Sopot, 81-756

  • Gastromed Sp. z o.o.

    Torun, 87-100

  • H-T. Centrum Medyczne-Endoterapia

    Tychy, 43-100

  • NZOZ FOR MED sp. z o.o.

    Wadowice, 34-100

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04-501

  • Centrum Medyczne Oporów

    Wroclaw, 52-416

  • VISTAMED

    Wroclaw, 53-149

  • Melita Medical

    Wroclaw, 53-611

Other trials in Poland

Germany13 sites

  • Universitätsklinikum Augsburg, III. Medizinische Klinik Studienzentrum

    Augsburg, 86156

  • Charité Campus Virchow-Klinikum

    Berlin, 13353

  • Universitätsklinikum Brandenburg GmbH

    Brandenburg an der Havel, 14770

  • MVZ für spezialärztliche Versorgung Dr. Friedrichs GmbH

    Duisburg, 47055

  • Universitätsklinikum Frankfurt Goethe-Universität, Medizinische Klinik 1

    Frankfurt am Main, 60590

  • Interdisziplinäres Crohn Colitis Centrum Rhein-Main

    Frankfurt am Main, 60594

  • Studiengesellschaft BSF Unternehmergesellschaft

    Halle, 06108

  • HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen

    Hamburg, 20251

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105

  • Klinikum Rechts der Isar der TU München

    München, 81675

  • Magen-Darm-Zentrum Remscheid

    Remscheid, 42859

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Spain9 sites

  • Centro Medico Teknon - DIGESTIVO

    Barcelona, 8022

  • Hospital General Tomelloso

    Ciudad Real, 13700

  • Hospital Universitario Reina Sofia Comite Etico

    Córdoba, 14004

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de GC, 35019

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • CEIM Hospital Universitario y Politecnico la Fe

    Valencia, 46026

Other trials in Spain

Serbia8 sites

  • Clinical Center " Dr Dragisa Misovic Dedinje"

    Belgrade, 11000

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11000

  • Clinical Hospital Center Zvezdara

    Belgrade, 11000

  • Clinical Hospital Centre Zemun

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Center of Vojvodina

    Novi Sad, 21000

  • General Hospital Pancevo

    Pančevo, 26101

  • General Hospital "Djordje Joanovic"

    Zrenjanin, 23000

Other trials in Serbia

Greece7 sites

  • General Hospital of Athens 'Evangelismos'

    Athens, 10676

  • General Hospital of Athens Hippokratio

    Athens, 115 27

  • Sotiria Thoracic Diseases Hospital of Athens

    Athens, 11527

  • Alexandra Hospital

    Athens, 11528

  • PAGNI-University General Hospital of Heraklion

    Heraklion, 71500

  • University Hospital of Ioannina

    Ioannina, 45500

  • General Oncology Hospital of Kifissia "Agioi Anargiroi"

    Nea Kifissia, 14564

Other trials in Greece

Hungary7 sites

  • Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft

    Budapest, 1033

  • Óbudai Egészségügyi Centrum

    Budapest, 1036

  • Semmelweis University

    Budapest, 1088

  • Bugát Pál Kórház

    Gyöngyös, 3200

  • Clinexpert Gyöngyös Kft.

    Gyöngyös, 3200

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged, 6725

  • Fejér Megyei Szent György Egyetemi Oktató Kórház

    Székesfehérvár, 8000

Other trials in Hungary

Romania7 sites

  • Dr.Carol Davila Emergency University Central Military Hospital

    Bucharest, 010825

  • S.C. Centrul Medical Medicum SRL

    Bucharest, 012015

  • Colentina Clinical Hospital

    Bucharest, 020125

  • Emergency University Hospital

    Bucharest, 50098

  • Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor

    Cluj-Napoca, 400162

  • Valahia Medical Center SRL

    Ploieşti, 100032

  • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

    Timișoara, 300002

Other trials in Romania

Argentina6 sites

  • CIPREC

    CABA, C1061AAS

  • Mautalen Salud e Investigacion-Centro de Osteopatías Médicas

    Ciudad Autonoma de Buenos Air, C1128AAF

  • Clínica Privada Independencia

    Munro, 1605

  • CER Instituto Medico

    Quilmes, B1878DVB

  • Hospital Provincial del Centenario

    Rosario, S2002KDS

  • Centro Medico Privado de Reumatologia

    SAN M. de Tucuman, T4000AXL

Other trials in Argentina

Croatia6 sites

  • General Hospital Dr Andjelko Visic Bjelovar

    Bjelovar, 43000

  • Poliklinika Borzan

    Osijek, 31000

  • Special Hospital Medico

    Rijeka, 51000

  • General Hospital Dr. J. Bencevic

    Slavonski Brod, 35 000

  • Poliklinika Solmed

    Zagreb, 10000

  • University Hospital Center Zagreb

    Zagreb, 10000

Other trials in Croatia

France6 sites

  • Henri Mondor Hospital

    Créteil, 94010

  • CHU De Grenoble Hopital Albert Michallon

    Grenoble, 38043

  • Centre Hospitalier Departemental (CHD) Vendee

    La Roche-sur-Yon, 85925

  • CHU de Nice Hopital de L'Archet

    Nice, 06202

  • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -

    Pierre-Bénite, 69495

  • Chu de Rouen Hopital Charles Nicolle

    Rouen, 76031

Other trials in France

Canada4 sites

  • London Health Sciences Centre

    London, N6A 5W9

  • London Digestive Disease Institute

    London, N6K 1M6

  • CIUSSS de l'Est-de-l'Île-de-Montréal

    Montreal, H1T 2M4

  • Montreal General Hospital

    Montreal, H3G 1A4

Other trials in Canada

Czechia4 sites

  • SurGal clinic s.r.o.

    Brno, 60200

  • Vojenska nemocnice Brno p.o.

    Brno, 615 00

  • Etická komise Nemocnice Slaný

    Slaný, 27401

  • Etická komise Krajské nemocnice T. Bati, a. s.

    Zlín, 762 75

Other trials in Czechia

Turkey (Türkiye)4 sites

  • Gazi University Medical Faculty Gazi Hospital

    Ankara, 6560

  • Ege Universitesi Hastanesi

    Izmir, 35100

  • İnönü Üniversitesi Tıp Fakültesi

    Malatya, 44280

  • Mersin University Medical Faculty Hospital

    Mersin, 33169

Other trials in Turkey (Türkiye)

Colombia3 sites

  • Hospital Universitario Mayor Méderi

    Bogotá, 111411

  • Comité de Ética en Investigación Biomédica IPS Centro Médico Julián Coronel

    Cali, 750035

  • Centro de Inmunología y Genética (CIGE)

    Medellín, 5001000

Other trials in Colombia

Belgium2 sites

  • Chu Tivoli

    La Louvière, 7100

  • CHU UCL Namur site Godinne

    Yvoir, 5530

Other trials in Belgium

Latvia2 sites

  • Liepaja Regional Hospital

    Liepāja, LV-3414

  • Pauls Stradins Clinical Univeristy Hospital

    Riga, LV-1002

Other trials in Latvia

Denmark1 site

  • Bispebjerg Hospital

    København NV, 2400

Other trials in Denmark

Ireland1 site

  • Beaumont Hospital, Dublin

    Dublin, D9

Other trials in Ireland

About this study

Official title: An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination With Mirikizumab for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis

The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).

Read the detailed description

The study will last approximately 4-5 years. Screening is required within 35 days prior to enrollment. For each participant, the total duration of the clinical trial will be about 69 weeks including screening.

Being tested
Eltrekibart, Mirikizumab, Placebo
Keywords
CXCR1/2 Ligand receptor antagonist, IL-23 p19 antibody, Gastrointestinal Diseases, Inflammatory Bowel Diseases, Digestive System Diseases, Colonic Diseases, Intestinal Diseases, Colitis, Colitis, Ulcerative, Anti-Inflammatory Agents, Mirikizumab, Eltrekibart, Adult, Moderate to Severe
Medical subject headings
Colitis, Ulcerative, Gastrointestinal Diseases, Inflammatory Bowel Diseases, Digestive System Diseases, Colonic Diseases, Intestinal Diseases, Colitis

What participants receive

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

  • EltrekibartDrug

    Also called LY3041658

    Administered

  • MirikizumabDrug

    Also called LY3074828

    Administered

  • PlaceboDrug

    Administered

Study groups in NCT06598943
Study groupRoleWhat they receive
Eltrekibart + PlaceboExperimentalParticipants will receive eltrekibart with placebo, eltrekibart or mirikizumab.
Receives: Drug: Eltrekibart; Drug: Mirikizumab; Drug: Placebo
Mirikizumab + PlaceboExperimentalParticipants will receive mirikizumab and placebo or mirikizumab.
Receives: Drug: Mirikizumab; Drug: Placebo
Eltrekibart + MirikizumabExperimentalParticipants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.
Receives: Drug: Eltrekibart; Drug: Mirikizumab
PlaceboExperimentalParticipants will receive placebo or mirikizumab.
Receives: Drug: Mirikizumab; Drug: Placebo

What is being measured

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

  1. Percentage of Participants Achieving Clinical Remission

    Percentage of Participants Achieving Clinical Remission

    Measured: Week 12

Secondary outcomes (8)

  1. Percentage of Participants Achieving Clinical Response

    Percentage of Participants Achieving Clinical Response

    Measured: Week 12

  2. Percentage of Participants Achieving Endoscopic Improvement

    Percentage of Participants Achieving Endoscopic Improvement

    Measured: Week 12

  3. Percentage of Participants Achieving Endoscopic Remission

    Percentage of Participants Achieving Endoscopic Remission

    Measured: Week 12

  4. Percentage of Participants Achieving Clinical Remission

    Percentage of Participants Achieving Clinical Remission

    Measured: Week 52

  5. Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement

    Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement

    Measured: Week 12

  6. Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score

    Change From Baseline to Week 12 in IBDQ Total Score

    Measured: Baseline, Week 12

  7. Pharmacokinetics (PK): Trough concentrations at Steady State (Ctrough ss) of Eltrekibart

    PK: Ctrough ss of Eltrekibart

    Measured: Week 12

  8. PK: Ctrough ss of Mirikizumab

    PK: Ctrough ss of Mirikizumab

    Measured: Week 12

Timeline

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

  1. First posted19 Sep 2024
  2. Study start10 Oct 2024
  3. Primary completion3 Aug 2026
  4. Study completionJul 2027 (estimated)

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
143 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06598943
Sponsor's protocol ID
18751
Other IDs
I7P-MC-DSAG
Status last verified
Oct 2026
First submitted
13 Sep 2024
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eltrekibart and Mirikizumab in people with Ulcerative Colitis and Ulcerative Colitis Chronic, run by Eli Lilly and Company at 207 sites in 21 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 207 sites in United States, Japan, Italy, Poland, Germany and 16 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 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?

This study is still under way. Results are not available in the source record yet.

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 Achieving Clinical Remission (time frame: Week 12). 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 NCT06598943.

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 7 Oct 2026.

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