Health Trials

Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

ConditionUlcerative Colitis (UC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXencor, Inc.

About this trial

The Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B). Part C of this study will be a Phase 2 study to evaluate XmAb942 in participants with ulcerative colitis (UC).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-55

Must be in good health with no significant medical history

Clinical laboratory values within normal range

BMI 18-35 (inclusive)

Disqualifiers

Any physical or psychological condition that prohibits study completion

History of suicidal behavior or suicidal ideation

Heavy use of nicotine containing products

HIV, hepatitis B and hepatitis C positive

Trial design

Design model

Parallel

Treatments tested in this trial

  • XmAb942

    Biological/Vaccine

    Antibody

  • Placebo

    Drug

    Placebo

Treatment groups

270 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part A: Active drugActive comparator 1 intervention
Group B: Part A: PlaceboPlacebo comparator 1 intervention
Group C: Part B: ActiveActive comparator 1 intervention
Group D: Part B: PlaceboPlacebo comparator 1 intervention
Group E: Part C: ActiveActive comparator 1 intervention
Group F: Part C: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
20 weeks
2

Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part B)

Time frame
28 weeks
3

Clinical remission based on modified mayo score (MMS), defined as MMS ≤ 2 with Mayo endoscopic score (MES) of 1, rectal bleeding subscore (RBS) of 0, and stool frequency subscore (SFS) of 0-1.

A composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9. It is calculated by adding the results from Mayo endoscopic subscore (MES) which measures GI bleeding, stool frequency subscore (SFS) which measures stool frequency per day, and rectal bleeding subscore (RBS), which measures presence of blood during stool passing. Each subscore is a scale of increasing severity from 0 to 3.

Time frame
12 weeks

Secondary outcomes

1

Serum PK parameters of XmAb942 in Healthy Volunteers (Part A)

• Cmax (Maximum concentration of drug)

Time frame
up to 20 weeks
2

Serum PK parameters of XmAb942 in Healthy Volunteers (Part A)

• AUC0-last (Area under the curve drug concentration-time curve to last concentration)

Time frame
up to 20 weeks
3

Serum PK parameters of XmAb942 in Healthy Volunteers (Part B)

• Cmax (Maximum concentration of drug)

Time frame
up to 28 weeks
4

Serum PK parameters of XmAb942 in Healthy Volunteers (Part B)

• AUC0-tau AUC within a dosing interval, calculated using the linear trapezoidal rule

Time frame
up to 28 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xencor, Inc.

Lead sponsor

Source ClinicalTrials.gov
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