Phase 1 / Phase 2: testing XmAb942 for Ulcerative Colitis (UC)

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are XmAb942, or Placebo. The registry lists allocation as randomized. The Phase 1 study described herein will measure the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B).

They plan to enroll about 270 people at 95 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Participants Followed by a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of XmAb942 in Participants With Moderate-To-Severe Active Ulcerative Colitis.

Interventions: XmAb942, Placebo

Primary outcome (registry wording): Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A)

Who it is for (from inclusion criteria)

• Ages 18 Years to 75 Years
• Must be in good health with no significant medical history
• Clinical laboratory values within normal range
• body-mass index (BMI) 18-35 (inclusive)
• Contraceptive use by men or women consistent with local regulations
• UC diagnosis ≥ 3 months prior to screening
• Diagnosis of moderately to severely active UC as defined by a (MMS) ≥ 5, with a MES ≥ 2 and RBS ≥ 1
• Evidence of UC extending ≥ 15 cm from the anal verge, as determined by screening colonoscopy