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NX-13 500mg MR for Ulcerative Colitis

Phase 1
Waitlist Available
Research Sponsored by Landos Biopharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
male and female subjects aged 18 to 75 years (inclusive) with a diagnosis of UC ≥ 90 days before screening;
active UC defined as a total Mayo Score of 4 to 10 (inclusive), at baseline, with a Mayo endoscopic subscore (MES) ≥ 2 confirmed by a central reader;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 63 days
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new drug, NX-13, on 40 people. The participants will be randomly assigned to receive either the drug or a placebo, and will take it once a day for 28 days.

Eligible Conditions
  • Ulcerative Colitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~63 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 63 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
Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13 in subjects with active ulcerative colitis (UC)
Secondary outcome measures
PK Parameters - Time to maximum concentration (tmax);
PK Parameters- Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-tlast);
PK Parameters- Maximum concentration (Cmax)
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: NX-13 500mg MRExperimental Treatment1 Intervention
Oral
Group II: NX-13 500mg IRExperimental Treatment1 Intervention
Oral
Group III: NX-13 250mg IRExperimental Treatment1 Intervention
Oral
Group IV: PlaceboPlacebo Group1 Intervention
Oral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NX-13 500mg MR
2021
Completed Phase 1
~40
NX-13 250mg IR
2021
Completed Phase 1
~40
NX-13 500mg IR
2021
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Landos Biopharma Inc.Lead Sponsor
8 Previous Clinical Trials
487 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
334 Patients Enrolled for Ulcerative Colitis
Jyoti ChauhanStudy DirectorLandos Biopharma Inc.
6 Previous Clinical Trials
337 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
254 Patients Enrolled for Ulcerative Colitis
Simon Lichtiger, MDStudy DirectorLandos Biopharma Inc.
7 Previous Clinical Trials
407 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
254 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~10 spots leftby Mar 2025