Today, we will be looking into the latest research and clinical trials focused on ulcerative colitis in adults.

The following list has been carefully curated by evaluating the ongoing Phase 3 trials for moderately to severe ulcerative colitis, specifically targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 12 months.

This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.

Without further ado, let us explore the list of Ulcerative Colitis Clinical Trials!

Quick View Table of UC Clinical Trials
Study TitlePhaseEnrollmentStart DateLast Update Posted
A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative ColitisPHASE 3160 5/17/20238/28/2024
A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative ColitisPHASE 3418 9/13/202210/31/2024
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative ColitisPHASE 31064 9/26/201911/18/2024
An Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisPHASE 3778 9/5/201911/20/2024
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative ColitisPHASE 31177 10/19/20189/5/2024
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)PHASE 31281 6/18/20187/3/2024
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA)PHASE 3557 2/27/20186/21/2024

Phase 3 Clinical Trials:

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

Study Details | Source

  • Sponsor: Eli Lilly and Company
  • A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.
  • Interventions: DRUG: Mirikizumab
  • Primary Outcomes Measures: Change from Baseline in Bowel Urgency Severity Urgency Numeric Rating Score (UNRS), Baseline, Week 12

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

Study Details | Source

  • Sponsor: Janssen Research & Development, LLC
  • The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
  • Interventions: DRUG: Guselkumab Dose 1 | DRUG: Guselkumab Dose 2 | DRUG: Guselkumab Dose 3 | OTHER: Placebo
  • Primary Outcomes Measures: Clinical Remission, Clinical remission per modified Mayo score., Week 12

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

Study Details | Source

  • Sponsor: Janssen Research & Development, LLC
  • The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).
  • Interventions: DRUG: Placebo | DRUG: Guselkumab
  • Primary Outcomes Measures: Induction Study 1: Percentage of Participants With Clinical Response at Week I-12, Clinical response was defined as a decrease from induction baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent (%) and \>=2 points, with either a \>=1 point decrease from baseline (Week 0 of IS-1) in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only., At Week I-12|Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12, Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only., At Week I-12|Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44, Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-1 and IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for randomized arms only., At Week M-44

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

Study Details | Source

  • Sponsor: Pfizer
  • The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 \[NCT03945188\] or APD334-302 \[NCT03996369\] or APD334-210 \[NCT04607837\]).
  • Interventions: DRUG: Etrasimod
  • Primary Outcomes Measures: Number and Severity of Safety Measures, Safety as assessed by the evaluation of adverse events, Up to approximately 8 years

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

Study Details | Source

  • Sponsor: Eli Lilly and Company
  • The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).
  • Interventions: DRUG: Mirikizumab SC|DRUG: Mirikizumab IV|DRUG: Placebo SC
  • Primary Outcomes Measures: “Percentage of Participants in Clinical Remission at Week 40, Clinical remission at week 40 is defined as achieving a 9-point modified Mayo score for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability). Stool Frequency Subscore, based on the participant’s diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal Bleeding Subscore, based on the participant’s diary and scored from 0 (no blood) to 3 (blood only passed); Endoscopy Subscore, based on central reading of colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)., Week 40”

An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

Study Details | Source

  • Sponsor: Eli Lilly and Company
  • The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.
  • Interventions: DRUG: Mirikizumab | DRUG: Placebo
  • Primary Outcomes Measures: “Percentage of Participants With Clinical Remission at Week 12, Clinical remission at week 12 is defined as achieving a modified Mayo score (MMS) subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability), excluding consideration of Physician’s Global Assessment (PGA). Stool frequency subscore, based on the participant’s diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal bleeding subscore, based on the participant’s diary and scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopy subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The confidence interval of 99.875% was chosen to match the significance level., Week 12”

A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA)

Study Details | Source

  • Sponsor: Shire
  • The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn’s disease (CD).
  • Interventions: DRUG: 25 mg Ontamalimab | DRUG: 75 mg Ontamalimab
  • Primary Outcomes Measures: Number of Participants With Treatment Emergent Adverse Events (TEAEs), An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs (TEAEs) were defined as AEs with start dates or worsening dates at the time of or following the first exposure to investigational product., From first dose of study drug up to end of study [EOS] (up to 5.79 years)|Number of Participants With Serious Infections, Serious infections were defined as any infections that were life-threatening or those requiring hospitalization or intravenous antibiotics based on the investigator’s assessment., From first dose of study drug up to EOS (up to 5.79 years)|Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time, Clinical laboratory assessments included hematology, serum chemistry and urinalysis. Any notable changes in the clinical laboratory value over time based on the investigator interpretation were reported., From first dose of study drug up to EOS (up to 5.79 years)|Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time, ECG included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals parameters measurement. Any discernible changes in the ECG value over time based on investigator interpretation were reported., From first dose of study drug up to EOS (up to 5.79 years)|Number of Participants With Discernible Changes in Vital Signs Over Time, Vital sign assessments included blood pressure, pulse, respiratory rate, and temperature. Any discernible changes in vital signs over time per investigator interpretation were reported., From first dose of study drug up to EOS (up to 5.79 years)

Potential Guideline That May Be Affected Includes:

There you have it – a list of phase 3 Clinical Trials for Ulcerative Colitis as of December 2024. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.

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