Crohn Disease

162

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

Condition / disease
Location
Status: Available

Expanded Access to Upadacitinib

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Trial details
Biological sex: AllType: Expanded AccessSponsor: AbbVieUpdated: Aug 20, 2026
Eligibility criteria

There are other suitable treatment options. [+1]

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: Recruiting

Lesion Size Measurement During Gastrointestinal Endoscopies

The goal of this prospective observational study is to assess the accuracy and reliability of laser readings obtained through AccuMeasure, in comparison to other measurements performed by gastroenterologists. AccuMeasure is a novel technology, that has emerged as a promising tool for measuring polyps and lesions during colonoscopies. The system employs laser-based measurements, enabling precise determination of lesion size, depth, and extent. The main hypotheses this study aims to evaluate are: * AccuMeasure technology, with its precise laser measurements, will demonstrate superior accuracy and reliability in assessing lesion size of pathologies encountered during endoscopies, when compared to other endoscopic scoring methods. * AccuMeasure measurements will show strong construct validity by correlating significantly with endoscopic subscores, symptomatic remission (CD PRO2 \<8, partial mayo score), and fecal calprotectin values.

Participants needed: 3,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Centre hospitalier de l'Université de Montréal (CHUM)Updated: Aug 18, 2026Locations: 1
Eligibility criteria

Adult patients (18 years and older) [+1]

Minors: Patients under 18 years of age. [+3]

Status: Recruiting

PIBD-SETQuality: the Inception Cohort and Safety Registry

The purpose of this study is to analyse effectiveness and safety signals of current treatment strategies in routine practice for patients with pediatric-onset inflammatory bowel disease (PIBD) and to correlate this to their individual risk factors.

Participants needed: 1,500
Trial details
Age: 0-19Biological sex: AllType: ObservationalSponsor: Erasmus Medical CenterUpdated: Aug 11, 2026Locations: 2Duration: 20 Years
Eligibility criteria

Diagnosis is based on history, physical examination, laboratory, endoscopic, rad... [+4]

Inability to read and understand the patient and family information sheets (for... [+2]

Status: Recruiting

A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease

The main purpose of this study is to see how the safety and efficacy of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD). This study is part of the IIBD master protocol and will last approximately 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

Participants taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP...

Must not have a hepatic disease [+7]

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: Recruiting

Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission

The purpose of this study is to compare the effectiveness and safety of a strategy of switching to an alternative targeted immunomodulator (TIM) therapy to treat to a target of endoscopic remission, versus continuing index TIM in patients with inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis \[UC\]) in symptomatic remission with moderate to severe endoscopic inflammation despite optimization of index TIM in a real-world setting.

Participants needed: 216
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Mayo ClinicUpdated: Aug 7, 2026Locations: 24
Eligibility criteria

Male or nonpregnant, nonlactating females, ≥ 18 years of age. [+24]

Presence of ostomy or ileoanal pouches. [+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: 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: Recruiting

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

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 Crohn's disease (a long-term, progressive \[worsens with time\] and life-threatening disease of the intestine).

Participants needed: 460
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Janssen Research & Development, LLCUpdated: Jul 31, 2026Locations: 55
Eligibility criteria

Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater t... [+3]

Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcer... [+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 Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Participants needed: 530
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Janssen Research & Development, LLCUpdated: Jul 31, 2026Locations: 144
Eligibility criteria

Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with... [+5]

Has complications of CD such as symptomatic strictures or stenoses, short gut sy... [+4]

Status: Recruiting

A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Participants needed: 1,092
Trial details
Phase: Phase 2, Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Janssen Research & Development, LLCUpdated: Jul 31, 2026Locations: 368
Eligibility criteria

Diagnosis of CD established at least 12 weeks before screening including both en... [+4]

Has complications of CD, such as symptomatic strictures or stenoses, short gut s... [+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: 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

Low Dose IL-2 for the Treatment of Crohn's Disease

The purpose of this study is to determine the safety and maximum effective dose (MED) of Interleukin-2 in subjects with moderate-to-severe crohn's disease.

Participants needed: 30
Trial details
Phase: Phase 1, Phase 2Age: 12-80Biological sex: AllType: InterventionalSponsor: Boston Children's HospitalUpdated: Aug 3, 2026Locations: 3
Eligibility criteria

Age 12-80 years. Maximum age limit for subjects recruited at BCH will be 30 year... [+9]

A diagnosis of ulcerative colitis or indeterminate colitis. [+19]

Status: Recruiting

Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO

This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and/or effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.

Participants needed: 300
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: National Cancer Institute (NCI)Updated: Jul 31, 2026Locations: 52
Eligibility criteria

Patients can have either histologically confirmed malignancy that is radiologica... [+53]

Repeat imaging demonstrates no new sites of bone metastases [+13]

Status: Recruiting

STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP

Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can dramatically affect the quality of life of patients. Due to its transmural nature (involvement of the entire thickness of the intestinal wall), it naturally progresses to intestinal destruction (stenosis, fistula) which requires intestinal resection in approximately half of patients during their follow-up. The long-term goal for patients is to maintain a normal life, that is, without symptoms and without intestinal destruction. For this, the short and medium term therapeutic objectives have evolved in recent years. Clinical remission is not a sufficient goal since it has failed to alter the natural history of the disease. The current objective to be achieved is the combination of clinical remission and endoscopic mucosal healing since it is associated with a reduced risk of progression (reappearance of symptoms, hospitalization, intestinal resection). Fecal calprotectin, better accepted than colonoscopy, is a non-invasive biomarker of endoscopic inflammatory activity in CD. The CALM study recently showed that close follow-up with clinical and biological evaluation (assays of CRP and fecal calprotectin), called "tight control", associated with therapeutic intensification in the absence of clinical or biological remission, was associated with a better rate of endoscopic mucosal healing at 1 year than follow-up based solely on symptoms. Thus, the "CALM" strategy is considered to be the current benchmark. Transmural healing evaluated by MRI is also a promising objective associated with a reduced risk of progression (reappearance of symptoms, hospitalization, bowel resection). In addition, it could prevent intestinal destruction. A recent study by our team suggested that calprotectin (mucosal assessment) and MRI (transmural assessment) may be complementary and be a better therapeutic goal. We hypothesize that a "CALM + MRI" strategy concomitantly targeting transmural healing would be superior to the "CALM" strategy alone in maintaining clinical remission without corticosteroids in patients with CD treated with biotherapies.

Participants needed: 180
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospital, Clermont-FerrandUpdated: Jul 30, 2026Locations: 17
Eligibility criteria

Adult Crohn's disease (age ≥ 18 years) [+5]

Severe obstructive symptoms [+9]

Status: Recruiting

A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis

Probiotics are live microorganisms that provide health benefits when consumed in sufficient amounts. Traditional probiotics, mainly from the Lactobacillus and Bifidobacterium genera, originate from fermented foods or the human gut and are widely used in supplements. Although considered safe and easy to produce, they are not specifically designed to treat diseases, and no official health claims have been approved by EFSA. Advances in microbiome research have led to the discovery of Next-Generation Probiotics (NGPs), which are newly identified gut microbes associated with health and offer promising therapeutic potential despite lacking a long history of safe use.

Participants needed: 20
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Catholic University of the Sacred HeartUpdated: Jul 27, 2026Locations: 1
Eligibility criteria

Men or women 18 to 80 years of age at the time of consent [+4]

concomitant immunosuppressive therapy, including but not limited to thiopurines,... [+11]

Status: Recruiting

Autologous Stem Cell Transplant for Crohn's Disease

Crohn's Disease (CD) is an inflammatory bowel disease. It can lead to significant complications and discomfort in the stomach and intestines. Crohn's disease is a debilitating, incurable disease of immune cells; it affects almost 1 million people in the United States. CD is characterized by inflammation of the stomach and intestine as well as organs outside of the intestines such as the skin, eyes, and joints. Current therapies to treat CD aim to suppress the patient's immune cells but these therapies become ineffective for the majority of patients and lead to complications including the requirement for surgical bowel resection, impaired quality of life, and lifelong disability. Hematopoietic stem cell transplantation (HCT) is a procedure used to treat a number of medical conditions including Crohn's disease. To improve success of HCT in CD doctors considered combining transplant with other drugs to improve the chances of achieving remission and also maintaining the remission. The Investigators' plan in this study is to incorporate the drug Vedolizumab after transplant to test if this drug will improve remission and make patients healthier. Patients may qualify to take part in this research study because Crohn's disease is active, because surgery is not a treatment option and because there is evidence that the disease has failed to respond to treatments for Crohn's disease including the following: * corticosteroids * azathioprine, 6-mercaptopurine, methotrexate * Anti-TNFα (infliximab, adalimumab, certolizumab, golimumab) * Anti-integrin agents (natalizumab, Vedolizumab) If patients meet entry criteria will undergo a baseline endoscopy, colonoscopy and MR or CT enterography. If documentation of active mucosal disease patients will then be tapered off of current medications and undergo stem cell mobilization. Mobilization will involve low dose chemotherapy, growth factors and require 1-2 week hospitalization. Patients will then undergo stem cell transplant which will involve high dose chemotherapy and require a 2-4 week hospitalization. After restoration of the immune system patients will be placed on vedolizumab per standard dosing (0,2,6 then 8 every weeks) for a total of 8 doses. Patients will have monthly study visits and a repeat colonoscopy and MR/CT scan at 6 months.

Participants needed: 50
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Aaron EtraUpdated: Jul 24, 2026Locations: 1
Eligibility criteria

Diagnosis of Crohn's disease by standard criteria [+10]

History of significant toxicity to any medications used in trial (cyclophosphami... [+9]

Status: Recruiting

Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease

This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for inflammatory bowel disease. This research will increase the understanding of the role of a self-management program in improving health and health-related quality of life for patients with inflammatory bowel disease. The study team hypothesizes: * the study will achieve a recruitment rate of 10 participants every 3 months * 70% participant retention at 24 weeks * 70% outcome data collection * 70% intervention completion * high acceptability

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of MichiganUpdated: Jul 23, 2026Locations: 1
Eligibility criteria

Diagnosis of Inflammatory Bowel Disease (IBD) based on conventional clinical, en... [+4]

Unable to speak and read English [+5]

Status: Recruiting

Cranberry and Gut Health in Crohn's Disease

This study is investigating whether a cranberry-based dietary supplement, rich in polyphenols and fiber, can enhance gut health in individuals with Crohn's disease. People with Crohn's disease often have an imbalance in their gut microbiome (the community of bacteria in the gut). Previous research suggests that cranberry compounds may help support beneficial gut bacteria. In this study, adults with Crohn's disease will be randomly assigned to one of two groups: one group will receive a cranberry supplement to take once daily for 10 weeks, and the other group will receive a placebo (a supplement with no active ingredients). All participants will be asked to complete online questionnaires and collect samples of their blood, urine, and stool at four time points over a total of 15 weeks. These samples will help researchers understand how the cranberry supplement affects the gut microbiome, inflammation, and overall health. Participation is voluntary, and participants can withdraw from the study at any time. The results of this study may help identify new diet-based approaches to improve gut health in individuals with Crohn's disease.

Participants needed: 50
Trial details
Phase: Early Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: Ana Maldonado-ContrerasUpdated: Jul 20, 2026Locations: 1
Eligibility criteria

Adult CD patients between 18 and 65 years old. [+10]

Ostomy [+10]

Status: Recruiting

Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD

This is an open-label, single-arm, phase 4 study to assess the safety and efficacy of mirikizumab in approximately 60 participants with stricturing CD.

Participants needed: 60
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Alimentiv Inc.Updated: Jul 16, 2026Locations: 5
Eligibility criteria

Nonpregnant, nonlactating adults, ≥ 18 years of age. [+14]

History or current diagnosis of UC, indeterminate colitis, ischemic colitis, non... [+30]

Status: Recruiting

Evaluation of the Accuracy of Immunostaining of Claudin 2 to Detect Active or Inactive Inflammation in Endoscopic Biopsies of IBD

In view of the increasing evidence of the importance of mucosal healing as a combination of endoscopic and histologic healing, and the complexity and lack of complete agreement of the evaluation of histologic healing in IBD, the aim of this study will be to evaluate the accuracy of a new methodology, the immunostaining for Claudine 2 as compared to others standard well-accepted scoring for histologic activity in IBD. The aim is compare the accuracy of this methodology and in addition the correlation with outcomes (i.e. relapse, hospitalization, surgery).

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: IRCCS Policlinico S. DonatoUpdated: Jul 17, 2026Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease

To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children.

Participants needed: 50
Trial details
Age: 2-16Biological sex: AllType: InterventionalSponsor: Tongji HospitalUpdated: Jul 10, 2026Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

Fecal Microbiota Transplantation in Pediatric Crohn's Disease

This study will test the safety and effectiveness of fecal microbiota transplantation (FMT) plus partial enteral nutrition (PEN) in refractory pediatric Crohn's disease (CD) who have failed conventional treatment

Participants needed: 40
Trial details
Age: 2-16Biological sex: AllType: InterventionalSponsor: Biao ZouUpdated: Jul 10, 2026Locations: 1
Eligibility criteria

Not listed