Colitis, Ulcerative

43

Review clinical trials related to Colitis, Ulcerative. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)

The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that MK-8690 is superior to placebo with respect to the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.

Participants needed: 100
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Merck Sharp & Dohme LLCUpdated: Aug 21, 2026Locations: 28
Eligibility criteria

Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months b... [+4]

Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory b... [+12]

Status: Recruiting

Intestinal Ultrasound Guided Management in Inflammatory Bowel Disease

This randomized controlled trial evaluates whether adding point-of-care intestinal ultrasound (IUS) to standard of care changes clinical management in patients with inflammatory bowel disease (IBD). Adult patients with Crohn's disease or ulcerative colitis undergoing colonoscopy for disease assessment are randomized 1:1 to standard of care plus IUS at every visit, or standard of care alone, and followed for 48 weeks. The primary outcome is the proportion of patients with a change in treatment.

Participants needed: 137
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Mahidol UniversityUpdated: Aug 20, 2026Locations: 1
Eligibility criteria

Diagnosis of inflammatory bowel disease for more than 2 months [+2]

Pregnancy [+3]

Status: Not yet recruiting

A Study to Evaluate the Safety, Tolerability, PK and Preliminary Efficacy of HX15001 Combined With Etrasimod in Moderate-severe Ulcerative Colitis

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HX15001 injection combined with Etrasimod tablets in participants with moderately to severely active ulcerative colitis (UC).

Participants needed: 32
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: Helixon Biotechnology (Suzhou) Co., LtdUpdated: Aug 17, 2026Locations: 1
Eligibility criteria

Patient able to read and understand, and willing to sign the informed consent fo... [+7]

Evidence or history (within 6 months) of fulminant colitis, toxic megacolon, or... [+38]

Status: Recruiting

A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease

Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.

Participants needed: 60
Trial details
Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: Eli Lilly and CompanyUpdated: Aug 6, 2026Locations: 70
Eligibility criteria

Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease... [+4]

Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassifi... [+8]

Status: Not yet recruiting

A Study to Investigate the Safety and Tolerability of Multiple Study Interventions in Participants With Moderate to Severe Ulcerative Colitis

This study will look at how safe and tolerable different treatments are for adults who have moderate to severe ulcerative colitis (UC). The platform design uses one single master protocol that explains how the overall study is organized, whereas each treatment, as sub-study will be tested to see how well the study drug works and how it affects participants.

Participants needed: 16
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: GlaxoSmithKlineUpdated: Aug 5, 2026
Eligibility criteria

Diagnosis of UC for greater than or equal (>=) 3 months before screening. Approp... [+5]

Participants with current diagnosis of Crohn's disease (CD) or Inflammatory bowe... [+23]

Status: Not yet recruiting

A Study of Continued Use of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting

The purpose of this study is to find out how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.

Participants needed: 35
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Janssen Sciences Ireland UCUpdated: Aug 5, 2026
Eligibility criteria

Participant must be eligible for biologic treatment and initiate guselkumab acco... [+2]

Contraindicated to guselkumab per the label [+4]

Status: Not yet recruiting

A Sub Study to Investigate the Safety and Tolerability of Aletekitug in Participants With Moderate To Severe Ulcerative Colitis

This goal of this sub-study is to learn how safe and tolerable the study drug, aletekitug (anti-IL-18), in participants with moderately to severely active ulcerative colitis (UC). This study is the sub-study of the platform trial.

Participants needed: 16
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: GlaxoSmithKlineUpdated: Aug 5, 2026
Eligibility criteria

Diagnosis of UC for greater than or equal (>=) 3 months before screening. Approp... [+6]

Participants with current diagnosis of Crohn's disease (CD) or Inflammatory bowe... [+21]

Status: Recruiting

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).

Participants needed: 644
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Janssen Research & Development, LLCUpdated: Jul 31, 2026Locations: 63
Eligibility criteria

Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screen... [+3]

Isolated proctitis (UC limited to the rectum only or to less than [<] 20 centime... [+4]

Status: Not yet recruiting

A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically

The purpose of this post-marketing study is to assess the amount of guselkumab in breast milk of lactating women receiving guselkumab as part of their standard clinical care provided by their treating physician, for any of the approved indications.

Participants needed: 10
Trial details
Phase: Phase 4Age: 18+Biological sex: FemaleType: InterventionalSponsor: Janssen Research & Development, LLCUpdated: Jul 31, 2026Locations: 1
Eligibility criteria

Has an active diagnosis of at least one approved indication for guselkumab (psor... [+6]

Has any current or previous illness that, in the opinion of the investigator, mi... [+4]

Status: Recruiting

A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis

The purpose of this study is to evaluate how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.

Participants needed: 35
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Janssen-Cilag Pharma GmbHUpdated: Jul 31, 2026Locations: 1
Eligibility criteria

Must be eligible for biologic treatment and initiate guselkumab according to the... [+2]

Contraindicated to guselkumab per the label [+4]

Status: Recruiting

A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis

The purpose of this study is to assess the measurable changes in health, function, or quality of life (clinical outcomes) after receiving guselkumab in real-world clinical practice amongst Chinese participants with ulcerative colitis (UC; a long-term disease of the large intestine in which the lining of the colon \[part of large intestine\] becomes inflamed and develops tiny open ulcers), who have not received biologic therapy (a medicine made from living organisms or their components) previously.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Xian-Janssen Pharmaceutical Ltd.Updated: Jul 31, 2026Locations: 10
Eligibility criteria

Has a confirmed diagnosis of moderately to severely active UC, defined as: a) ba... [+3]

Acute severe UC or infectious colitis or other conditions when patients is likel... [+4]

Status: Recruiting

A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).

Participants needed: 882
Trial details
Phase: Phase 3Age: 12+Biological sex: AllType: InterventionalSponsor: Janssen Research & Development, LLCUpdated: Jul 31, 2026Locations: 400
Eligibility criteria

Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screen... [+5]

Participants with current known complications of UC such as fulminant colitis, t... [+4]

Status: Recruiting

A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).

Participants needed: 196
Trial details
Phase: Phase 3Age: 3+Biological sex: AllType: InterventionalSponsor: Janssen Research & Development, LLCUpdated: Jul 31, 2026Locations: 49
Eligibility criteria

Must have completed the dosing planned in the primary pediatric guselkumab study [+3]

Participant is greater than or equal to (>=) 18 years of age and resides in a co... [+5]

Status: Recruiting

A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis

The purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).

Participants needed: 1,536
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Janssen Scientific Affairs, LLCUpdated: Jul 31, 2026Locations: 1
Eligibility criteria

Adult men and women with CD or UC who are new users of ustekinumab or the compar... [+1]

Participants below 18 years of age on the exposure index date [+4]

Status: Recruiting

A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis

This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.

Participants needed: 645
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Spyre Therapeutics, Inc.Updated: Jul 28, 2026Locations: 259
Eligibility criteria

Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology... [+2]

Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefin... [+2]

Status: Recruiting

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

Participants needed: 120
Trial details
Phase: Phase 2, Phase 3Age: 2-17Biological sex: AllType: InterventionalSponsor: Bristol-Myers SquibbUpdated: Jul 23, 2026Locations: 90
Eligibility criteria

Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Scr... [+2]

Diagnosis of Crohn's disease or indeterminate colitis [+4]

Status: Not yet recruiting

Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study

Inflammatory Bowel Disease (IBD) patients have an increased risk of ColoRectal Cancer (CRC). The cumulative risk of CRC development is estimated at 1% after 10 years of disease progression, 2% after 20 years, and 5% after more than 20 years of disease progression (1). The incidence of CRC in IBD has gradually declined, attributed to enhanced detection of preneoplastic lesions (dysplasia), improved adherence to screening recommendations, utilization of advanced high-definition endoscopes (2-4), and the implementation of more efficacious therapeutic strategies (5-9). Presently, there is no consensus on the endoscopic management of dysplastic lesions. Recent techniques such as submucosal dissection (ESD) enable the resection of non-polypoid flat lesions larger than 2 cm. Lesions previously treated with colectomy can now be resected by ESD with en-bloc resection rates of approximately 85.7% (17). However, long-term data on the risk of local or distant recurrence after endoscopic resection in IBD is lacking. It is crucial to evaluate complete (R0) and curative resection rates, as well as the rate of local recurrence, based on the type of endoscopic treatment. In light of the 21st century advancements, characterized by high-definition endoscopes and targeted treatments, it is imperative to: * Assess the prevalence and incidence of dysplasia in IBD and its risk of progression to CRC. * Specifically characterize the endoscopy and histology of pre-neoplastic lesions in IBD to facilitate better selection of lesions amenable to endoscopic treatment or surgery. * Evaluate the rates of local and distant recurrence over time, considering factors associated with this evolving risk (IBD characteristics, endoscopic appearance, histology, type of resection, etc.).

Participants needed: 800
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUpdated: Jul 22, 2026Duration: 5 Years
Eligibility criteria

Patients age ≥ 18 years [+6]

Patient followed for ileal Crohn's disease (L1) [+5]

Status: Recruiting

Confirmatory Clinical Study in Active Ulcerative Colitis

The main goal of the study is to check if MH002 works and is safe to use. In a previous study in 45 patients with Ulcerative Colitis, MH002 was found to have favorable effects. In this study, 2 different doses will be tested, and long-term treatment effects will be investigated. MH002 is a live biotherapeutic product (LBP). This is a biological medicine containing live bacteria used to restore the normal function of a gut that is damaged by ulcerative colitis (UC). Ulcerative colitis is a bowel disease that causes inflammation and sores in the gut.

Participants needed: 204
Trial details
Phase: Phase 2Age: 16+Biological sex: AllType: InterventionalSponsor: MRM Health NVUpdated: Jul 9, 2026Locations: 16
Eligibility criteria

Documented diagnosis (histologic diagnosis and either endoscopic or radiographic... [+5]

Diagnosis of Crohn's disease, undetermined colitis, ischemic colitis, fulminant... [+20]

Status: Recruiting

An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis

The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment of choice according to the physician and they have not previously taken etrasimod. All patients will be prescribed etrasimod according to standard of care. Tests and doctor visits will be conducted according to standard of care with the exception of health questionnaires about ulcerative colitis symptoms. These questionnaires will be completed by patients at various timepoints during the study using their mobile phone, tablet, or computer. The study is 52 weeks with 28 days of safety follow up. The effects of etrasimod will be analyzed for each patient comparing their disease activity prior to the start of etrasimod.

Participants needed: 300
Trial details
Age: 18-64Biological sex: AllType: ObservationalSponsor: PfizerUpdated: Jul 9, 2026Locations: 28
Eligibility criteria

Age ≥ 18 years and < 65 years at baseline [+2]

The presence of clinical findings suggestive of Crohn's disease [+8]

Status: Recruiting

A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)

The purpose of this study is to evaluate the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD) under real-world settings. CD and UC are the main type of Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.

Participants needed: 220
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Janssen-Cilag Ltd.Updated: Jul 6, 2026Locations: 1
Eligibility criteria

Must be eligible for biologic treatment and initiate guselkumab according to the... [+2]

Contraindicated to guselkumab per the label [+4]

Status: Recruiting

A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany

The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) treated with Guselkumab in a real-world setting, and to assess the clinical effectiveness (how well the treatment works) in the overall population and in different participant subgroups. Furthermore patient-reported outcomes like fatigue, health-related quality of life (HRQoL), sexuality, work productivity and activity as well as treatment satisfaction will be assessed.

Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Janssen-Cilag G.m.b.HUpdated: Jul 6, 2026Locations: 1
Eligibility criteria

Must be eligible for biologic treatment and initiate guselkumab according to the... [+2]

Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD)... [+3]

Status: Recruiting

A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants

The purpose of this study is to collect and evaluate the following information in relation to the safety and the efficacy of Jyseleca tablet (Filgotinib Maleate) 100 milligram (mg) and 200 mg in this post marketing setting: (1) Serious adverse events and adverse drug reactions (2) Unexpected adverse events and adverse drug reactions not reflected in precautions for use (3) Known adverse drug reactions (4) Non-serious adverse events and adverse drug reactions (5) Other safety and effectiveness related information will be evaluated in accordance with the permitted articles under the actual conditions of use in Korea.

Participants needed: 2,040
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Eisai Korea Inc.Updated: Jul 6, 2026Locations: 59
Eligibility criteria

Korean local label therapeutic indications of Jyseleca tablet. In the following... [+7]

Individuals who fall under contraindications to the administration of Jyseleca t... [+13]

Status: Not yet recruiting

Retrospective Observational Multicenter Study on the Treatment Patterns, Extra-Intestinal Manifestations, Resource Utilisation, and Outcomes of Patients With Inflammatory Bowel Disease in Dutch Hospitals

This multicenter retrospective real-world data study will evaluate the treatment pathways and disease burden of adult patients with Crohn's disease (CD) and ulcerative colitis (UC) treated in 5-10 Dutch hospitals between 2018 and 2026. The study will assess: * Treatment sequences, switching patterns, and treatment duration * Prevalence and incidence of extra-intestinal manifestations (EIMs) * Healthcare resource utilization (hospitalizations, outpatient visits, endoscopies, surgery, and length of stay) * Direct healthcare costs * Availability of disease activity biomarkers Using linked administrative, prescription, procedure, and laboratory data, outcomes will be analyzed by age, line of therapy, and clinical characteristics. Special focus will be placed on the impact of EIMs on treatment patterns, healthcare utilization, and costs. The findings will provide real-world evidence on IBD management in the Netherlands and support clinical decision-making, healthcare planning, and future research on treatment optimization and coexisting immune-mediated conditions.

Participants needed: 3,500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: LOGEXUpdated: Jul 2, 2026
Eligibility criteria

Adult patients (≥18 years of age) who required secondary (hospital) care after J...

Patients who have formally objected to the use of their hospital data for scient...

Status: Recruiting

A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis

The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in pediatrics participants (≥ 2 years up to \< 12 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment).

Participants needed: 24
Trial details
Phase: Phase 2Age: 2-11Biological sex: AllType: InterventionalSponsor: PfizerUpdated: Jun 26, 2026Locations: 25
Eligibility criteria

Not listed

Status: Recruiting

Resting Energy Expenditure in Pediatric Patients With Inflammatory Bowel Disease (REE-MICI)

This multicenter prospective observational non-pharmacological study aims to evaluate resting energy expenditure (REE) in pediatric patients affected by inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. REE will be measured using indirect calorimetry and estimated using predictive equations. The study also aims to investigate the relationship between REE, disease activity, and dietary or pharmacological treatments. Clinical, laboratory, anthropometric, nutritional, and disease activity data will be collected during routine clinical follow-up at diagnosis, after induction therapy, and during follow-up visits.

Participants needed: 50
Trial details
Age: 6-17Biological sex: AllType: ObservationalSponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUpdated: Jun 26, 2026Locations: 1
Eligibility criteria

Pediatric patients aged 6 to 17 years [+2]

Intestinal surgery within 6 weeks before the first evaluation [+2]