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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 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
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 III: NX-13 PlaceboPlacebo Group1 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.

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
~47 spots leftby Dec 2025
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