Providence, RINCT07683325Now EnrollingIRB Ready

Fibrostenotic Crohn's Disease Clinical Trial in Providence, RI

Access cutting-edge fibrostenotic crohn's disease treatment through this phase 2 clinical trial at a research site in Providence. Study-provided care at no cost to qualified participants.

Sponsored by Agomab Spain S.L.U.

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Expert Care in Providence

Access fibrostenotic crohn's disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related fibrostenotic crohn's disease treatment provided free

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Check if you qualify for this fibrostenotic crohn's disease clinical trial in Providence, RI

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Why Participate?

  • No-Cost Study Care

  • Local to Providence

    Convenient for RI residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Providence site if eligible
  4. 4Begin participation

About This Fibrostenotic Crohn's Disease Study in Providence

Many patients with Crohn's disease (CD) develop fibrotic narrowing (strictures) in their bowel, causing obstructive symptoms such as abdominal pain, cramping, or vomiting after meals. Because of these symptoms, patients often require bowel resection surgery. The objective of this clinical trial is to evaluate the efficacy, safety, and dose-response relationship of ontunisertib in participants with CD and symptomatic strictures, and contribute to the validation of novel endpoints to assess potential treatment benefit in patients with fibrostenosing Crohn's disease (FSCD). The participants will be in the trial for a duration of up to 60 weeks, consisting of a 6-week screening period (with 2 screening visits), a 52-week treatment period, and a 2-week follow-up period. The visit frequency in the treatment period will be every 6 to 8 weeks.

Sponsor: Agomab Spain S.L.U.

Who Can Participate

Inclusion Criteria

Diagnosis of ileal or ileocolonic CD based on clinical and endoscopic or radiological evidence established at least 12 weeks prior to signing the ICF.
Presence of at least 1 endoscopically non-passable ileal stricture.
Present stricture(s) can be naïve or anastomotic, and will be confirmed by centrally read MRE.
Presence of (sub)obstructive symptoms AND/OR dietary restrictions like limiting the amount or type of food, and/or food processing methods.
Participants should be on stable anti-inflammatory background therapy for CD and agree to maintain stable background therapy for the duration of the trial.
Participants should have a body mass index ≥18 kg/m2 and \<35 kg/m2.
Not expected in the investigator's opinion to require hospitalization, endoscopic balloon dilation, surgical resection, or optimized anti-inflammatory therapy during the first 4 weeks of the trial.

Exclusion Criteria

History or current diagnosis of ulcerative colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug-induced colitis, idiopathic colitis (i.e., colitis not consistent with CD), radiation colitis, microscopic colitis, colonic mucosal dysplasia, untreated bile acid malabsorption, or infectious colitis.
CD-related complications:
Short bowel syndrome (\<200 cm small bowel remaining).
Ileostomy (diverting or end), colostomy, small bowel stoma, or ileoanal pouch.
Internal fistulae and sinus tracts deriving from the area of stenosis. Participants with perianal fistulae could be included if not septic.
Anal and perianal stricture.
Suspected or diagnosed active intra-abdominal or perianal abscess that has not been appropriately treated and abscess in relation to the stricture.
Toxic megacolon.
Blind-ending sinus could be included.
Endoscopic balloon dilation or surgical treatment of the index small bowel stricture within the last 6 months prior to screening.
Current or history of valvulopathy, or moderate or severe heart valve function defect, including moderate or severe valve stenosis or regurgitation OR left ventricular ejection fraction \<50% as assessed locally through echocardiography.
Any other severe acute or chronic medical condition, psychiatric disorder, laboratory abnormality, or systemic or opportunistic infection that may increase the risk associated with trial participation or trial treatment administration, or may interfere with the interpretation of trial results, as determined by the investigator.
Clinically significant abnormal vital signs, physical examination, or abnormalities at 12-lead ECG at screening or baseline.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Providence?

Yes, this clinical trial (NCT07683325) has an active research site in Providence, RI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Fibrostenotic Crohn's Disease Treatment Options in Providence, RI

If you're searching for fibrostenotic crohn's disease treatment options in Providence, RI, this clinical trial (NCT07683325) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Providence research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced fibrostenotic crohn's disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all fibrostenotic crohn's disease clinical trials near you to find additional studies recruiting in your area.

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