RightFit
RecruitingPhase 2

A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

A Phase 2, Multi-Center, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics With Multiple Therapies in Participants With Active Crohn's Disease or Active Ulcerative Colitis (ASCEND-IBD)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This Phase 2 study tests how safe several study drugs are and how well they work for inflammatory bowel disease (IBD). It is for adults with moderately to severely active Crohn’s disease or ulcerative colitis.

This is a Phase 2, multicenter, platform study in adult participants with IBD (moderately to severely active Crohn's Disease or Ulcerative Colitis). The primary goal of this study is to assess the safety and efficacy of multiple investigational drugs.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Crohn’s disease or ulcerative colitis confirmed by a camera exam of the gut and testing of tissue samples.
  • For Crohn’s disease: Have moderately to severely active disease based on symptom and gut exam scores.
  • For ulcerative colitis: Have moderately to severely active disease based on a three-part disease score.
  • Meet the study’s rules for keeping medicines stable.

Who can't join

  • For Crohn’s disease: Have colitis, or swelling in the colon, whose type is unclear.
  • For Crohn’s disease: Have a known or suspected abscess (pocket of pus) in the belly or near the anus at screening.
  • For Crohn’s disease: Have had more than 100 cm of small intestine or more than two sections of the colon removed.
  • For Crohn’s disease: Have disease only in the stomach, upper or middle small intestine, or near the anus, without disease in the colon or last part of the small intestine.
  • For ulcerative colitis: Have now, or have had in the past 6 months, very severe colon swelling, a dangerously widened colon, or a hole in the bowel.
  • For ulcerative colitis: Have a stoma (a bowel opening through the belly) or will soon need surgery to make one.
  • For ulcerative colitis: Received steroid medicine through a vein within 14 days before screening or during screening.
  • For ulcerative colitis: Have had surgery to remove the whole colon and rectum, or most of the colon.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria-Crohn's Disease: * Diagnosis of Crohn's Disease (CD), as confirmed by endoscopy and histopathology * Moderately to severely active CD as defined by Clinical Disease Activity Index (CDAI) and Simple Endoscopic Score (SES-CD) * Meets drug stabilization requirements Inclusion Criteria-Ulcerative Colitis: * Diagnosis of Ulcerative Colitis (UC), as confirmed by endoscopy and histopathology * Moderately to severely active UC as defined by a 3-component MMCS * Meets drug stabilization requirements Exclusion Criteria-Crohn's Disease: * Diagnosis of indeterminate colitis * Suspected or diagnosed intra-abdominal or perianal abscess at Screening * Previous small bowel resection with combined resected length of \> 100 cm or previous colonic resection of \> 2 segments * CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement Exclusion Criteria-Ulcerative Colitis: * Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation * Current stoma or impending need for colostomy or ileostomy * Received IV corticosteroids within 14 days prior to Screening or during the Screening Phase * Previous total proctocolectomy or subtotal colectomy

Study sites (46)

AL

AR

AZ

CO

FL

GA

IL

LA

MI

MO

NC

NV

NY

OH

RI

SC

TN

TX

WA

WI