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ClinicalTrials.gov 45 recruiting now official registry

Ulcerative Colitis clinical trials

45 of 123 indexed Ulcerative Colitis trials are currently recruiting.

123 US clinical trials · 45 currently recruiting

Ulcerative Colitis is the subject of 123 registered US clinical trials on ClinicalTrials.gov, 45 of them currently open to new participants. 32 are in Phase 3-4 (later-stage) and 47 in Phase 1-2 (earlier-stage). The most active sponsor is Eli Lilly and Company, running 9 of these trials.

The research picture

Ulcerative Colitis has 123 registered US clinical trials, 45 of them open to new participants right now, about 37% of the total.

45
recruiting participants now
37%
of trials open to enrollment
32
in Phase 3–4 (later-stage)
9
top sponsor: Eli Lilly and Company
Phase 115Phase 232Phase 328Phase 44

Active & Recent Trials

123 total, page 2 of 3

ACTIVE NOT RECRUITING Phase 2 1,064 participants

A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

Janssen Research & Development

NCT04033445

ACTIVE NOT RECRUITING Phase 3 1,063 participants

A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

Eli Lilly and Company

NCT03519945

ACTIVE NOT RECRUITING Phase 3 1,020 participants

A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

Merck Sharp & Dohme

NCT06052059

ACTIVE NOT RECRUITING Phase 3 896 participants

An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

Pfizer

NCT03950232

ACTIVE NOT RECRUITING 537 participants

An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis

Janssen Biotech

NCT02808780

ACTIVE NOT RECRUITING 292 participants

Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease

The Cleveland Clinic

NCT04827368

ACTIVE NOT RECRUITING Phase 2 228 participants

Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis

Gilead Sciences

NCT06290934

ACTIVE NOT RECRUITING Phase 3 172 participants

A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis

Eli Lilly and Company

NCT05767021

ACTIVE NOT RECRUITING Phase 2 156 participants

A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis

AbbVie

NCT06257875

ACTIVE NOT RECRUITING Phase 2 132 participants

A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)

AnaptysBio

NCT06127043

ACTIVE NOT RECRUITING Phase 4 124 participants

Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial

Beth Israel Deaconess Medical Center

NCT04835506

ACTIVE NOT RECRUITING NA 123 participants

A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy

University of Maryland, Baltimore

NCT05316584

ACTIVE NOT RECRUITING Phase 3 122 participants

Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.

AbbVie

NCT05782907

ACTIVE NOT RECRUITING Phase 3 118 participants

Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis

Pfizer

NCT04624230

ACTIVE NOT RECRUITING Phase 2 50 participants

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics

AltruBio

NCT06109441

ACTIVE NOT RECRUITING Phase 2 45 participants

A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis

Boehringer Ingelheim

NCT06636656

ACTIVE NOT RECRUITING Phase 2 42 participants

Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis

Northwestern University

NCT04767984

ACTIVE NOT RECRUITING Phase 2 40 participants

Aquamin® as an Adjuvant Intervention for Ulcerative Colitis

Muhammad N Aslam, MD

NCT03869905

ACTIVE NOT RECRUITING NA 32 participants

Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis

Rush University Medical Center

NCT05213234

ACTIVE NOT RECRUITING Phase 1 30 participants

CP101 for the Treatment of Ulcerative Colitis

Brigham and Women's Hospital

NCT05852574

ACTIVE NOT RECRUITING Phase 1 20 participants

Angiographic Delivery of AD-MSC for Ulcerative Colitis

Mayo Clinic

NCT04312113

ACTIVE NOT RECRUITING 18 participants

Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis

Alimentiv

NCT03765450

ACTIVE NOT RECRUITING Phase 2 16 participants

Phase 2a to Evaluate PL-8177 in Subjects with Active Ulcerative Colitis (UC)

Palatin Technologies

NCT05466890

COMPLETED 200,000 participants

General Surgical Outcomes Quality Improvement Database (UH-SOCRATES)

University Hospitals Cleveland Medical Center

NCT00622557

COMPLETED Phase 3 1,177 participants

A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Eli Lilly and Company

NCT03524092

COMPLETED Phase 3 1,027 participants

A Comparison of Once a Day Dose Compared to 2 Doses/Day

Warner Chilcott

NCT00505778

COMPLETED 974 participants

Study to Determine Risk Factors for Post-operative Infection in Inflammatory Bowel Disease

Icahn School of Medicine at Mount Sinai

NCT02054533

COMPLETED Phase 3 547 participants

A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis

Pfizer

NCT01458951

COMPLETED Phase 3 510 participants

Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

Bausch Health Americas

NCT01532648

COMPLETED 465 participants

Comparative Effectiveness of Biologics or Small Molecule Therapies in Inflammatory Bowel Disease (IBD)

University of North Carolina, Chapel Hill

NCT04852666

COMPLETED Phase 3 443 participants

Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study

Bausch Health Americas

NCT00486031

COMPLETED Phase 3 393 participants

Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission

Bausch Health Americas

NCT00326209

COMPLETED Phase 2 357 participants

A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis

Shire

NCT01620255

COMPLETED Phase 3 348 participants

Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)

University of Maryland, Baltimore

NCT01692743

COMPLETED NA 320 participants

Trial on Impact of HealthPROMISE Mobile App on Inflammatory Bowel Disease Care and Quality of Life

Icahn School of Medicine at Mount Sinai

NCT02322307

COMPLETED Phase 2 319 participants

Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

Pfizer

NCT02958865

COMPLETED Phase 3 276 participants

Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)

Ferring Pharmaceuticals

NCT02522780

COMPLETED Phase 2 270 participants

Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis

Incara Pharmaceuticals

NCT00033943

COMPLETED Phase 2 199 participants

Efficacy and Safety Study of Ozanimod in Ulcerative Colitis

Celgene

NCT01647516

COMPLETED NA 140 participants

Improving Medication Adherence in Pediatric Inflammatory Bowel Disease

Children's Hospital Medical Center, Cincinnati

NCT01536509

COMPLETED Phase 3 123 participants

(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.

Bausch Health Americas

NCT00801723

COMPLETED 106 participants

Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease

Beth Israel Deaconess Medical Center

NCT01349504

COMPLETED Phase 2 105 participants

A Trial of Rosiglitazone for Ulcerative Colitis

James Lewis

NCT00065065

COMPLETED Phase 3 101 participants

Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

AbbVie

NCT02065557

COMPLETED 97 participants

Multi-center Acute Severe Ulcerative Colitis Cohort Study (MASCC)

Johns Hopkins University

NCT03669822

COMPLETED 89 participants

Fecal Biomarker Study for Patients With Ulcerative Colitis

Warner Chilcott

NCT00780507

COMPLETED NA 69 participants

Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease

Cedars-Sinai Medical Center

NCT00829595

COMPLETED Phase 3 69 participants

An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy

Corewell Health West

NCT00467922

COMPLETED Phase 2 60 participants

Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis

Novartis Pharmaceuticals

NCT00572585

COMPLETED Phase 2 59 participants

A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis

Lexicon Pharmaceuticals

NCT01456052

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Phase Distribution

PhaseTrial count
Phase 1 15
Phase 2 32
Phase 3 28
Phase 4 4

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Ulcerative Colitis Trial Landscape

123 indexed Ulcerative Colitis studies · 45 recruiting (37%).

Phase mix: 32 late (III/IV) vs 47 early (I/II).

Top sponsor: Eli Lilly and Company (9 trials), 9 others listed. 50 shown below, recruiting first.

How to read this condition's trial landscape

That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation, eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Ulcerative Colitis?

PlainTrial tracks 123 US clinical trials for Ulcerative Colitis, of which 45 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Ulcerative Colitis?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

Verify with NIH →

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial for this condition, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.