Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

Pfizer

Status and phase: Completed; Phase 2

Conditions: Colitis, Ulcerative

Treatments: Biological: Anrukinzumab; Other: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01284062

IMA-638 Anti-IL13 mAb

2010-023762-49 (EudraCT Number)

B2421003

Details and patient eligibility

About

This study represents the first investigation of anrukinzumab in patients with active ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.

Enrollment: 84 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female, Age >=18 and <=65 years
• Active ulcerative colitis (UC) beyond the rectum based upon Mayo Score
• women of childbearing potential with highly effective method of contraception

Exclusion criteria

• Indeterminate disease status, Crohn's disease, ischemic colitis, positive HIV, positive or history of tuberculosis infection, active enteric infections, transplant organ recipient, concomitant steroids, immunosuppressives or anti-TNFs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 4 patient groups, including a placebo group

Arm 1

Experimental group

Description:

200 mg PF-05230917, Anrukinzumab active dose level

Treatment:

Biological: Anrukinzumab

Biological: Anrukinzumab

Biological: Anrukinzumab

Arm 2

Experimental group

Description:

400 mg PF-05230917, Anrukinzumab active dose level

Treatment:

Biological: Anrukinzumab

Biological: Anrukinzumab

Biological: Anrukinzumab

Arm 3

Experimental group

Description:

600 mg PF-05230917, Anrukinzumab active dose level

Treatment:

Biological: Anrukinzumab

Biological: Anrukinzumab

Biological: Anrukinzumab

Arm 4

Placebo Comparator group

Description:

Matching placebo - administered at matching dose level 200 mg, 400 mg or 600 mg.

Treatment:

Other: placebo