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Crohn's DiseasePhase 2SPECIFI-CDNCT06637631

A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.

A Phase 2 study testing SAR441566 in people with Crohn's Disease, run by Sanofi at 141 sites in 24 countries.

Terminated

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

Official record
Search all trials

Trial summary

This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
SAR441566
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
141 sitesin 24 countries
Study dates
10 Dec 2024to 2 Oct 2026
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

  • Participants are eligible to be included in the study only if all of the following criteria apply:
  • Male or female participants aged 18 to 75 years at the time of signing the ICF
  • Confirmed diagnosis of CD for at least 3 months prior to Baseline
  • Confirmed diagnosis of moderate to severe CD as assessed by:
  • Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader
  • stool frequency (SF), abdominal pain (AP) score
Show all 9Show fewer
  • History of prior exposure to standard treatment (5-ASA, steroids, immunomodulators or antibiotics) or advanced therapies (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies
  • On stable doses of standard treatments prior to screening (oral 5-ASA compounds, oral corticosteroids, thiopurines (eg. AZA, 6-MP), or MTX)
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding.

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Participants with active UC, indeterminate colitis or short bowel syndrome
  • Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement
  • Participants with following ongoing known complications of CD: fistula, abscess, symptomatic stricture/stenosis, fulminant colitis, toxic megacolon, recent bowel resection within 3 months of screening or history of > 3 bowel resections
  • Participants with stool sample positive for infectious pathogens
  • Participants with active tuberculosis (TB) or a history of incompletely treated active or latent TB per local guidelines
Show all 20Show fewer
  • Participants with Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the Screening Visit
  • Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
  • Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
  • Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
  • History of colonic mucosal dysplasia or presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit
  • Infection(s) requiring treatment with IV anti infectives within 30 days or oral/intramuscular anti-infectives within 14 days prior to the screening visit
  • Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
  • Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
  • Participants who received fecal microbial transplantation within 30 days prior to screening
  • Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
  • Participants who received IV corticosteroids within 14 days prior to screening or during screening period
  • Participants who received therapeutic enema or suppository, other than required for colonoscopy within 14 days prior to screening or during screening
  • Screening laboratory and other analyses show abnormal results
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

141 sites in 24 countries.

141 sites in 24 countries

United States19 sites

  • University of Michigan Health System - Ann Arbor- Site Number : 8400017

    Ann Arbor, Michigan, 48109

  • Bristol Hospital- Site Number : 8400007

    Bristol, Connecticut, 06010

  • Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400016

    Charleston, South Carolina, 29401

  • Novum Research- Site Number : 8400021

    Clermont, Florida, 34711

  • Gi Alliance - Flowood- Site Number : 8400019

    Flowood, Mississippi, 39232

  • GI Alliance - Glenview- Site Number : 8400015

    Glenview, Illinois, 60026

  • Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014

    Greenville, North Carolina, 27834

  • Illinois Gastroenterology Group- Site Number : 8400011

    Gurnee, Illinois, 60031

  • Homestead Associates in Research- Site Number : 8400012

    Homestead, Florida, 33033

  • Gastro Health & Nutrition- Site Number : 8400003

    Katy, Texas, 77494

  • Clinical Research of Osceola- Site Number : 8400013

    Kissimmee, Florida, 34741

  • Vector Clinical Trials- Site Number : 8400001

    Las Vegas, Nevada, 89128

  • Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010

    Miami Lakes, Florida, 33016

  • Queens Village Primary Medical Center- Site Number : 8400005

    Queens Village, New York, 11428

  • Texas Digestive Disease Consultants - Southlake- Site Number : 8400002

    Southlake, Texas, 76092

  • GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020

    Sun City, Arizona, 85351

  • Washington Gastroenterology - Tacoma- Site Number : 8400008

    Tacoma, Washington, 98405

  • GCP Clinical Research- Site Number : 8400004

    Tampa, Florida, 33609

  • Frontier Clinical Research - Uniontown- Site Number : 8400009

    Uniontown, Pennsylvania, 15401

Other trials in United States

Japan14 sites

  • Investigational Site Number : 3920003

    Bunkyo-Ku, Tokyo, 113-8510

  • Investigational Site Number : 3920013

    Hiroshima, 734-8530

  • Investigational Site Number : 3920004

    Kashiwa, Chiba, 277-0871

  • Investigational Site Number : 3920005

    Kitakyushu, Fukuoka, 802-0077

  • Investigational Site Number : 3920020

    Nagaoka, Niigata, 940-2108

  • Investigational Site Number : 3920018

    Ōita, 870-0033

  • Investigational Site Number : 3920001

    Sakura, Chiba, 285-0841

  • Investigational Site Number : 3920006

    Sapporo, Hokkaido, 004-0041

  • Investigational Site Number : 3920010

    Sapporo, Hokkaido, 064-0919

  • Investigational Site Number : 3920007

    Sapporo, Hokkaido, 065-0033

  • Investigational Site Number : 3920019

    Takamatsu, Kagawa-ken, 760-0017

  • Investigational Site Number : 3920011

    Tokyo, 169-0073

  • Investigational Site Number : 3920012

    Wakayama, 640-8558

  • Investigational Site Number : 3920008

    Yahaba, Iwate, 028-3695

Other trials in Japan

China12 sites

  • Investigational Site Number : 1560008

    Changzhou, 213003

  • Investigational Site Number : 1560009

    Chongqing, 400013

  • Investigational Site Number : 1560012

    Fuzhou, 350005

  • Investigational Site Number : 1560001

    Guangzhou, 510080

  • Investigational Site Number : 1560002

    Guangzhou, 510655

  • Investigational Site Number : 1560004

    Hangzhou, 310009

  • Investigational Site Number : 1560003

    Hangzhou, 310016

  • Investigational Site Number : 1560007

    Hefei, 230022

  • Investigational Site Number : 1560011

    Nanchang, 330006

  • Investigational Site Number : 1560006

    Shanghai, 200025

  • Investigational Site Number : 1560005

    Shanghai, 200127

  • Investigational Site Number : 1560010

    Suzhou, 215004

Other trials in China

Hungary9 sites

  • Investigational Site Number : 3480003

    Békéscsaba, 5600

  • Investigational Site Number : 3480002

    Budapest, 1085

  • Investigational Site Number : 3480008

    Budapest, 1085

  • Investigational Site Number : 3480010

    Eger, 3300

  • Investigational Site Number : 3480001

    Gyöngyös, 3200

  • Investigational Site Number : 3480009

    Gyöngyös, 3200

  • Investigational Site Number : 3480005

    Szeged, 6720

  • Investigational Site Number : 3480006

    Szekszárd, 7100

  • Investigational Site Number : 3480004

    Tatabánya, 2800

Other trials in Hungary

India9 sites

  • Investigational Site Number : 3560007

    Hyderabad, 500032

  • Investigational Site Number : 3560003

    Hyderabad, 500048

  • Investigational Site Number : 3560009

    Jaipur, 302001

  • Investigational Site Number : 3560001

    Jaipur, 302007

  • Investigational Site Number : 3560005

    Kolkata, 700020

  • Investigational Site Number : 3560006

    Pune, 412201

  • Investigational Site Number : 3560002

    Secunderabad, 500003

  • Investigational Site Number : 3560013

    Surat, 395002

  • Investigational Site Number : 3560010

    Surat, 395010

Other trials in India

Georgia7 sites

  • Investigational Site Number : 2680006

    Kutaisi, 4600

  • Investigational Site Number : 2680007

    Tbilisi, 0102

  • Investigational Site Number : 2680001

    Tbilisi, 0144

  • Investigational Site Number : 2680005

    Tbilisi, 0159

  • Investigational Site Number : 2680002

    Tbilisi, 0160

  • Investigational Site Number : 2680003

    Tbilisi, 0172

  • Investigational Site Number : 2680004

    Tbilisi, 0180

Other trials in Georgia

Germany7 sites

  • Investigational Site Number : 2760004

    Berlin, 10318

  • Investigational Site Number : 2760002

    Berlin, 12203

  • Investigational Site Number : 2760001

    Fulda, 36043

  • Investigational Site Number : 2760005

    Halle, 06108

  • Investigational Site Number : 2760006

    Ludwigshafen, 67067

  • Investigational Site Number : 2760008

    Magdeburg, 39104

  • Investigational Site Number : 2760007

    Nordhausen, 99734

Other trials in Germany

Italy7 sites

  • Investigational Site Number : 3800009

    Milan, Milano, 20097

  • Investigational Site Number : 3800002

    Milan, Milano, 20132

  • Investigational Site Number : 3800001

    Padua, Padova, 35128

  • Investigational Site Number : 3800005

    Pisa, 56124

  • Investigational Site Number : 3800008

    Rome, Roma, 00128

  • Investigational Site Number : 3800006

    Rome, Roma, 00168

  • Investigational Site Number : 3800004

    Rozzano, Milano, 20089

Other trials in Italy

Argentina6 sites

  • Investigational Site Number : 0320003

    Buenos Aires, 1061

  • Investigational Site Number : 0320005

    Buenos Aires, 1119

  • Investigational Site Number : 0320001

    Buenos Aires, 1125

  • Investigational Site Number : 0320004

    Buenos Aires, 1221

  • Investigational Site Number : 0320006

    Buenos Aires, 1280

  • Investigational Site Number : 0320002

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Brazil5 sites

  • Hospital Moinhos de Vento- Site Number : 0760006

    Porto Alegre, Rio Grande do Sul, 90035-902

  • Hospital de Clinicas de Porto Alegre- Site Number : 0760007

    Porto Alegre, Rio Grande do Sul, 90035903

  • Hospital Ernesto Dornelles- Site Number : 0760002

    Porto Alegre, Rio Grande do Sul, 90160-093

  • Centro de Pesquisas da Clínica IBIS- Site Number : 0760001

    Salvador, Estado de Bahia, 41820-020

  • Pesquisare Saude- Site Number : 0760004

    Santo André, São Paulo, 09080-110

Other trials in Brazil

France5 sites

  • Investigational Site Number : 2500005

    Montpellier, 34090

  • Investigational Site Number : 2500002

    Nice, 06202

  • Investigational Site Number : 2500004

    Saint-Priest-en-Jarez, 42270

  • Investigational Site Number : 2500003

    Toulouse, 31059

  • Investigational Site Number : 2500001

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Poland5 sites

  • Investigational Site Number : 6160006

    Lublin, Lublin Voivodeship, 20-582

  • Investigational Site Number : 6160002

    Sopot, Pomeranian Voivodeship, 81-756

  • Investigational Site Number : 6160005

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Investigational Site Number : 6160004

    Warsaw, Masovian Voivodeship, 00-332

  • Investigational Site Number : 6160001

    Warsaw, Masovian Voivodeship, 02-507

Other trials in Poland

Chile4 sites

  • Investigational Site Number : 1520006

    Concepción, Biobio, 4070038

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8331143

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 8380456

  • Investigational Site Number : 1520002

    Viña del Mar, Valparaiso, 2540364

Other trials in Chile

Czechia4 sites

  • Investigational Site Number : 2030003

    Brno, 602 00

  • Investigational Site Number : 2030002

    Brno, 636 00

  • Investigational Site Number : 2030001

    Olomouc, 779 00

  • Investigational Site Number : 2030006

    Prague, 100 34

Other trials in Czechia

Netherlands4 sites

  • Investigational Site Number : 5280004

    Breda, 4818 CK

  • Investigational Site Number : 5280002

    Nijmegen, 6525 GA

  • Investigational Site Number : 5280001

    Tilburg, 5022 GC

  • Investigational Site Number : 5280003

    Utrecht, 3584 CX

Other trials in Netherlands

Romania4 sites

  • Investigational Site Number : 6420004

    Bucharest, 011461

  • Investigational Site Number : 6420005

    Cluj-Napoca, 400162

  • Investigational Site Number : 6420003

    Constanța, 900673

  • Investigational Site Number : 6420001

    Timișoara, 300002

Other trials in Romania

South Korea4 sites

  • Investigational Site Number : 4100001

    Daegu, Daegu, 41944

  • Investigational Site Number : 4100003

    Daejeon, Daejeon, 34943

  • Investigational Site Number : 4100002

    Haeundae-Gu, Busan, 48108

  • Investigational Site Number : 4100004

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

Australia3 sites

  • Investigational Site Number : 0360003

    Parkville, Victoria, 3050

  • Investigational Site Number : 0360001

    South Brisbane, Queensland, 4101

  • Investigational Site Number : 0360002

    Sydney, New South Wales, 2139

Other trials in Australia

Bulgaria3 sites

  • Investigational Site Number : 1000001

    Gorna Oryahovitsa, 5100

  • Investigational Site Number : 1000004

    Sofia, 1431

  • Investigational Site Number : 1000005

    Sofia, 1680

Other trials in Bulgaria

Canada3 sites

  • Investigational Site Number : 1240001

    Calgary, Alberta, T2N 4Z6

  • Investigational Site Number : 1240003

    Montreal, Quebec, H3H 1E8

  • Investigational Site Number : 1240005

    Québec, Quebec, G1N 4V3

Other trials in Canada

Croatia2 sites

  • Investigational Site Number : 1910004

    Osijek, 31000

  • Investigational Site Number : 1910003

    Zagreb, 10000

Other trials in Croatia

Spain2 sites

  • Investigational Site Number : 7240001

    Madrid, Madrid, Comunidad de, 28046

  • Investigational Site Number : 7240002

    Seville, Sevilla, 41009

Other trials in Spain

Turkey (Türkiye)2 sites

  • Investigational Site Number : 7920001

    Mersin, 33070

  • Investigational Site Number : 7920006

    Sanliurfa, 63290

Other trials in Turkey (Türkiye)

Mauritius1 site

  • Investigational Site Number : 4800001

    Vacoas

Other trials in Mauritius

About this study

Official title: A Phase 2, Multinational, Multicenter, Randomized, Doubleblind, Placebocontrolled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Crohn's Disease.

This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD.

This study will have an anticipated duration of up to 59 weeks which will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks, and a 2-week follow-up period after end of treatment for participants not enrolling in the Long Term Safety (LTS) study. The MS period includes a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance.

Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 40 weeks, depending on when participants switch.

Conditions
Crohn's Disease
Being tested
SAR441566, SAR441566 matching Placebo
Medical subject headings
Crohn Disease

What participants receive

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

  • SAR441566Drug

    Pharmaceutical form: Tablet Route of administration: Oral

  • SAR441566 matching PlaceboDrug

    Pharmaceutical form: Tablet Route of administration: Oral

Study groups in NCT06637631
Study groupRoleWhat they receive
SAR441566 dose 1ExperimentalParticipants will receive SAR441566 dose 1.
Receives: Drug: SAR441566
SAR441566 dose 2ExperimentalParticipants will receive SAR441566 dose 2.
Receives: Drug: SAR441566
SAR441566 dose 3ExperimentalParticipants will receive SAR441566 dose 3.
Receives: Drug: SAR441566
PlaceboPlacebo comparatorParticipants will receive SAR441566 matching placebo.
Receives: Drug: SAR441566 matching Placebo

What is being measured

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

  1. Proportion of participants achieving endoscopic response

    Endoscopic response is defined as ≥50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD).

    The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

    Measured: Week 12

Secondary outcomes (12)

  1. Proportion of participants achieving clinical remission based on Crohn's Disease Activity Index (CDAI)

    CDAI clinical remission is defined as CDAI score <150. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.

    Measured: Week 12

  2. Proportion of participants achieving Patient-Reported Outcome (PRO-2) remission

    PRO 2 remission is defined as the unweighted CDAI component of daily abdominal pain (AP) score ≤1, and the unweighted CDAI component of daily average stool frequency (SF) score ≤3 (ie, AP ≤1 and SF ≤3 and no worsening from baseline).

    Measured: Week 12

  3. Proportion of participants achieving both clinical remission and endoscopic response

    Clinical remission and endoscopic response based on CDAI <150 and ≥50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD)

    Measured: Week 12

  4. Proportion of participants achieving endoscopic remission based on centrally read SES-CD

    Endoscopic remission is defined as a centrally read SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease from baseline ≥2 points with no SES-CD sub score >1 point

    Measured: From Baseline to Week 12

  5. Proportion of participants achieving CDAI clinical response

    CDAI clinical response is defined as a CDAI reduction from baseline ≥100 points.

    Measured: From Baseline to Week 12

  6. Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission

    IBDQ remission is defined as IBDQ total score ≥170 points. The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with inflammatory bowel disease. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life.

    Measured: Week 12

  7. Proportion of participants achieving IBDQ response

    IBDQ response defined as an improvement of IBDQ scores by 27 points or more at Week 12 compared with baseline

    Measured: From baseline to Week 12

  8. Change from baseline in the IBDQ scores

    The total IBDQ score ranges from 32 to 224 which indicates better quality of life. A positive change from Baseline indicates improvement.

    Measured: From Baseline to week 12

  9. Plasma pre-dose concentrations of SAR441566 at selected visits

    Measured: Up to week 52

  10. Plasma post-dose concentrations of SAR441566 at selected visits

    Measured: Up to week 52

  11. Number of participants experiencing any TEAEs

    Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during double-blind (DB) induction and maintenance treatment period

    Measured: Up to week 52

  12. Number of participants experiencing any TEAEs

    Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during open-label treatment period

    Measured: From week 12 to week 52

Timeline

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

  1. First posted15 Oct 2024
  2. Study start10 Dec 2024
  3. Primary completion30 Jul 2026
  4. Study completion2 Oct 2026

Why it stopped: Business decision.

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06637631
Sponsor's protocol ID
DRI18212
Other IDs
2024-512633-32-00, U1111-1301-3830
Acronym
SPECIFI-CD
Status last verified
Oct 2026
First submitted
10 Oct 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR441566 in people with Crohn's Disease, run by Sanofi at 141 sites in 24 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 20 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 13 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 141 sites in United States, Japan, China, Hungary, India and 19 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 was stopped early (reason given: Business decision.). Results are not available in the source record.

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?

Proportion of participants achieving endoscopic response (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 NCT06637631.

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 13 Oct 2026.

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