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Oral NX-13 for Ulcerative Colitis

Phase 2

Recruiting

Led By Fabio Catalidi, MD

Research Sponsored by Landos Biopharma Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 365 days

Awards & highlights

Study Summary

This trial tests a drug to treat moderate to severe ulcerative colitis. Results will be studied over time.

Who is the study for?

This trial is for adults aged 18-75 with moderate to severe ulcerative colitis diagnosed at least 90 days prior. Participants must have a Mayo Score of ≥5 indicating active disease. Not eligible are those with fulminant colitis, toxic megacolon, Crohn's disease, infections, or conditions likely requiring hospitalization or surgery within 12 weeks.Check my eligibility

What is being tested?

The study tests two doses of NX-13 (250mg and 750mg) against a placebo in people with ulcerative colitis. It's a Phase 2 trial that includes an initial treatment phase followed by long-term extension to assess the drug's effectiveness and safety over time.See study design

What are the potential side effects?

While specific side effects for NX-13 aren't listed here, common side effects for new ulcerative colitis treatments can include gastrointestinal discomfort, headache, fatigue, and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 365 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~365 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To assess the clinical activity of oral NX-13 vs placebo

Secondary outcome measures

Safety and Tolerability-AE/SAE - Chemistry

Safety and Tolerability-AE/SAE - Hematology

Safety and Tolerability-AE/SAE - Vital Signs

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: NX-13 750mgExperimental Treatment1 Intervention

Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.

Group II: NX-13 250mgExperimental Treatment1 Intervention

Group III: NX-13 PlaceboPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Landos Biopharma Inc.Lead Sponsor

8 Previous Clinical Trials

446 Total Patients Enrolled

3 Trials studying Ulcerative Colitis

293 Patients Enrolled for Ulcerative Colitis

Fabio Catalidi, MDPrincipal InvestigatorLandos Biopharma Inc.

Media Library

NX-13 250mg (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05785715 — Phase 2

Ulcerative Colitis Research Study Groups: NX-13 250mg, NX-13 750mg, NX-13 Placebo

Ulcerative Colitis Clinical Trial 2023: NX-13 250mg Highlights & Side Effects. Trial Name: NCT05785715 — Phase 2

NX-13 250mg (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05785715 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for participation in this trial higher than 60 years old?

"The requirements for inclusion in this clinical trial specify that participants must have a minimum age of 18 and be no older than 75."

Answered by AI

What kind of health risks does NX-13 750mg pose to individuals?

"Data collected on NX-13 750mg is limited, thus it was given a rating of 2 out of 3 in terms of safety. This Phase 2 trial has demonstrated adequate security measures but not yet proved efficacy."

Answered by AI

Are there any establishments in North America presently engaged with this experiment?

"Patients can receive treatment at the Digestive Health Center of Michigan in Chesterfield, MI, Washington University School of Medicine in St. Louis, MO and INTEGRIS Baptist Medical Centre in Oklahoma City OK - alongside 24 additional clinical trial sites."

Answered by AI

What are the criteria for enrolling in this medical experiment?

"This clinical trial is seeking 80 patients with ulcerative colitis ranging from 18-75 years in age."

Answered by AI

Are there any openings in this scientific experiment that can be filled by potential participants?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical trial was published on April 24th 2023 and has since been amended as recently as May 8th 2023. The enrollment goal is 80 participants from 27 separate sites."

Answered by AI

What is the enrolment capacity of this trial?

"To conduct this medical experiment, 80 individuals meeting the specified inclusion criteria are needed. Landos Biopharma Inc., is responsible for managing the trial at sites such as Digestive Health Center of Michigan in Chesterfield and Washington University School of Medicine's branch in St Louis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis

2023. "Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05785715.

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