A Multi-Stage Study to Test a New Drug in Healthy Adult Volunteers, Then in Adults with Ulcerative Colitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Xencor Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

26 Jan 2026 → ongoing

Decision date (initial)

2026-01-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Xencor Inc.

External identifiers

EU CT number

2025-522702-21-00

ClinicalTrials.gov

NCT06619990

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate the efficacy of XmAb942 on inducing clinical remission in participants with moderately to severely active UC

Secondary objectives 5

1. To characterize the safety and tolerability of XmAb942
2. To evaluate the efficacy of XmAb942 on inducing endoscopic improvement
3. To evaluate the efficacy of XmAb942 on MMS
4. To evaluate the efficacy of XmAb942 on inducing clinical response
5. To evaluate the efficacy of XmAb942 on inducing histologic improvement

Conditions and MedDRA coding

Ulcerative Colitis is a type of inflammatory bowel disease, a chronic relapsing and remitting gastrointestinal disorder causing inflammation of the colonic and rectal mucosa.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1) Age 18-75
2. 2) Must be in good health with no significant medical history.
3. 3) Diagnosis of UC for ≥ 3 months prior to screening.
4. 4) Diagnosis of moderately to severely active UC as defined by a modified Mayo score (MMS) of ≥ 5, with a Mayo endoscopic subscore (ES) of ≥ 2 and rectal bleeding subscore ≥ 1.
5. 5) Evidence of UC extending ≥ 15 cm from the anal verge, as determined by screening colonoscopy.
6. 6) Must have inadequate response to, loss of response to, or intolerance to at least 1 of the conventional or advanced therapies for UC.
7. 7) Able and willing to provide written informed consent.

Exclusion criteria 6

1. 1) Any physical or psychological condition that prohibits study participation.
2. 2) Diagnosis of Crohn's disease, indeterminate colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis.
3. 3) Positive screen for Clostridium difficile (C. Difficile) toxins.
4. 4) HIV, hepatitis B and hepatitis C positive.
5. 5) Cardiac arrhythmia, or clinically significant abnormal ECG.
6. 6) Pregnant or breastfeeding.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Clinical remission at Week 12, defined as an MMS ≤ 2, with ES of ≤ 1 (excluding friability), a rectal bleeding (RB) subscore of 0, stool frequency (SF) subscore of ≤ 1 (with a ≥ 1 point decrease from baseline).

Secondary endpoints 5

1. TEAEs, treatment-related TEAEs, SAEs, discontinuations due to treatment related TEAEs.
2. Endoscopic remission defined as an ES ≤ 1 (excluding friability) at Week 12.
3. MMS score at baseline and Week 12.
4. Clinical response at Week 12 defined as: o decrease from baseline in the MMS of ≥ 2 points and at least a 30% reduction from baseline, and o decrease ≥ 1 point in RB from baseline or RB of ≤ 1
5. Histologic improvement (as defined in the Statistical Analysis Plan [SAP]) at Week 12.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Xencor Inc.

Sponsor organisation

Xencor Inc.

Address

465 North Halstead Street Suite 200

City

Pasadena

Postcode

91107-3291

Country

United States

Scientific contact point

Organisation

Xencor Inc.

Contact name

Mark Osterman, MD MSCE

Public contact point

Organisation

Xencor Inc.

Contact name

Mark Osterman, MD MSCE

Third parties 9

Locations

11 EU/EEA countries · 51 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 94 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

13 submissions — initial application plus substantial / non-substantial modifications