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

Landos Biopharma

Status and phase: Enrolling; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: NX-13 Placebo; Drug: NX-13 250mg; Drug: NX-13 750mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05785715

NX-13-201

Details and patient eligibility

About

Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).

Full description

This is a randomized, multicenter, double-blind, placebo-controlled, multiple dose exploratory Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult subjects aged 18 to 75 years (inclusive)
• Diagnosis of UC ≥ 90 days before screening confirmed by histologic evidence
• Active UC defined as a total Mayo Score (MMS) of ≥ 5 (inclusive) at baseline
• ES ≥ 2 within 14 days prior to randomization
• RBS ≥ 1.

Exclusion criteria

• Severe extensive colitis as evidenced by physician judgment that the participant is likely to require hospitalization for medical care or surgical intervention of any kind for UC (e.g., colectomy) within the 12 weeks after randomization;
• Current evidence of fulminant colitis, toxic megacolon or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation
• Diagnosis of Crohn's disease (CD) or indeterminate colitis, or the presence or history of a fistula consistent with CD
• Diagnosis of microscopic colitis, ischemic colitis, or radiation colitis
• Bacterial or parasitic pathogenic enteric infection;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 3 patient groups, including a placebo group

NX-13 250mg

Experimental group

Description:

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.

Treatment:

Drug: NX-13 250mg

NX-13 750mg

Experimental group

Description:

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.

Treatment:

Drug: NX-13 750mg

NX-13 Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: NX-13 Placebo