Colitis, Ulcerative

42

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 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: Oct 8, 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: 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: Oct 6, 2026Locations: 273
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 Remotely Conducted 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. This is a fully remote (virtual) study. Participants can complete all study-related activities, including consent, study visits, and breast milk sample collection, from home without attending an in-person study site.

Participants needed: 10
Trial details
Phase: Phase 4Age: 18+Biological sex: FemaleType: InterventionalSponsor: Janssen Research & Development, LLCUpdated: Oct 5, 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

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.

Participants needed: 1,380
Trial details
Phase: Phase 3Biological sex: AllType: InterventionalSponsor: Merck Sharp & Dohme LLCUpdated: Oct 2, 2026Locations: 37
Eligibility criteria

Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study fo... [+4]

Has prematurely discontinued study intervention in their parent study [+2]

Status: Not yet recruiting

A Study to Assess Guselkumab in Participants With Moderate-to-Severe Inflammatory Bowel Disease in Real Life Italian Setting

The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) receiving guselkumab in a real-world setting, and to evaluate treatment persistence (continuation) and clinical effectiveness (how well it works) in the overall population and in predefined participant subgroups. The study will also assess patient-reported outcomes, including fatigue (low energy), health-related quality of life (HRQoL), and treatment satisfaction. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Janssen-Cilag Ltd.Updated: Oct 1, 2026
Eligibility criteria

The participant must have a confirmed diagnosis of moderate-to-severe CD or UC r... [+2]

The participant is currently enrolled in an interventional clinical study [+3]

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: Sep 28, 2026Locations: 38
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

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: Sep 30, 2026Locations: 40
Eligibility criteria

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

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

Status: Not yet recruiting

A Real-World Study of Guselkumab Persistence and Effectiveness in Participants With Crohn's Disease or Ulcerative Colitis

The purpose of this study is to evaluate how long participants with moderate-to-severe Crohn's Disease (CD) and Ulcerative Colitis (UC) continue treatment with guselkumab in a real-world setting. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Janssen-Cilag, S.A.Updated: Sep 30, 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 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: Sep 25, 2026
Eligibility criteria

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

Contraindicated to guselkumab per the label [+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: Sep 25, 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: Sep 25, 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 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: Sep 25, 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 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: Sep 25, 2026Locations: 402
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 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: Sep 25, 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 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: Sep 25, 2026Locations: 51
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 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: Sep 24, 2026Locations: 91
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

LMT503 First-in-human SAD, MAD, and FE Study

This is a double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part with integrated food effect (FE) arm, and a multiple ascending dose (MAD) part to assess the safety, tolerability, and PK of ascending single and multiple oral doses of LMT503. The study will start with the SAD part.

Participants needed: 72
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: Lmito Therapeutics Inc.Updated: Sep 1, 2026Locations: 1
Eligibility criteria

Age : 18 to 65 years, inclusive, at screening [+12]

Previous participation in the current study. [+14]

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: Aug 28, 2026Locations: 170
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: 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: Aug 28, 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 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: Aug 24, 2026Locations: 42
Eligibility criteria

Not listed

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: 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 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: 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]