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A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥18 Years With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype (LIBERTY-UC SUCCEED (Study in UC for Clinical Efficacy Evaluation of Dupilumab))

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Sanofi

Status and phase

Enrolling
Phase 2

Conditions

Colitis Ulcerative

Treatments

Drug: Placebo
Drug: Dupilumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05731128
ACT17746
U1111-1278-4042 (Registry Identifier)

Details and patient eligibility

About

The protocol of this Phase 2 clinical trial consists of a double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of dupilumab in participants with moderately to severely active Ulcerative Colitis (UC) with an eosinophilic phenotype.

Screening period: 2 to up to 4 weeks

Treatment period:

52-week investigational medicinal product (IMP) intervention (dupilumab or matching placebo) from Week 0 to Week 52 Open-label arm (optional): administration of open-label dupilumab therapy for study participants who qualify. Follow-up period: 12 weeks The maximum duration of study per participant is up to 68 weeks.

Enrollment

84 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants must be ≥18 years of age at the time of signing the informed consent.
  • Evidence of biomarker enrichment at time of screening.
  • Moderately to severely active UC, defined as a baseline modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopic subscore assigned during the concurrent local and central reading of the video endoscopy.
  • Has a screening endoscopy with ≥2 endoscopic subscore in the Mayo score component assessment as determined by concurrent local and central reading of the video endoscopy.
  • Has a baseline rectal bleeding subscore of ≥1 and baseline a stool frequency score of ≥1 as determined by the Mayo score component assessment.
  • Participants with inadequate response/non-response, loss of response, or are intolerant of standard biologic therapy for their UC AND/OR Inadequate or non-responders, have shown loss of response, or are intolerant to at least 1 of the following treatments: oral corticosteroids (≤20 mg/day), 5-aminosalicylic acid (ASA) compounds, immunomodulators, small molecules.

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

  • Severe extensive colitis as evidenced by:

    • Current hospitalization
    • Likely to require surgery for the treatment of UC within 12 weeks of Screening Visit
  • UC limited to the rectum only or to <20 cm of the colon as determined by central reading.

  • Presence of an ileal pouch, ostomy, stoma or fistula or history of a fistula.

  • Require, or required within the 2 months before screening, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage, or other conditions possibly confounding the evaluation of benefit from study agent treatment.

  • Has a prior medical history of eosinophilic colitis.

  • Participants with abdominal abscess, fulminant disease, or toxic megacolon.

  • Participants with intestinal failure or short bowel syndrome.

  • Presence of symptomatic colonic or small bowel obstruction, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy).

  • History of extensive colonic resection (eg, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity.

  • History of colonic mucosal dysplasia or presence of adenomatous colonic polyps not removed OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit.

  • If the participant has extensive colitis for ≥8 years or disease limited to left side of colon (ie, distal to splenic flexure) for >10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.

  • Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

84 participants in 3 patient groups, including a placebo group

Dupilumab
Experimental group
Description:
Initial loading dose followed by regular administration for the duration of the treatment period.
Treatment:
Drug: Dupilumab
Placebo
Placebo Comparator group
Description:
Initial loading dose followed by regular administration for the duration of the treatment period.
Treatment:
Drug: Placebo
Open-label arm (optional)
Other group
Description:
Regular administration of open label dupilumab
Treatment:
Drug: Dupilumab

Trial contacts and locations

75

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Central trial contact

Trial Transparency email recommended (Toll free number for US & Canada)

Data sourced from clinicaltrials.gov

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