A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis

Roche

Status and phase: Completed; Phase 2

Conditions: Moderate to Severe Ulcerative Colitis

Treatments: Drug: Chronic- PF-06480605 450 mg SC Q4W; Drug: Chronic- PF-06480605 150 mg SC Q4W; Drug: Induction- PF-06480605 150 mg SC Q4W; Drug: Chronic- PF-06480605 50 mg SC Q4W; Other: Induction- Placebo SC Q4W; Drug: Induction- PF-06480605 450 mg SC Q4W; Drug: Induction- PF-06480605 50 mg SC Q4W

Study type: Interventional

Funder types: Industry

Identifiers

NCT04090411

Tuscany 2 (Other Identifier)

2019-002698-74 (EudraCT Number)

TL1A (Other Identifier)

B7541007

Details and patient eligibility

About

This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.

Enrollment: 246 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:-

• A diagnosis of UC for ≥3 months.

• Participants with moderate to severe active UC as defined by a Total Mayo Score of

  ≥6, and an endoscopic subscore of ≥2.

• Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy).

• Must have failed or been intolerant to at least one of the following class of medications: steroids, immunosuppressants, anti-TNFs, anti-integrin inhibitors, anti- IL-12/23 inhibitors, or JAK inhibitors.

Exclusion Criteria:

• Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohn's disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas, etc.).
• Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study
• Chest Radiograph showing abnormalities: The study will accept a Chest x-ray or computed tomography scan of the chest examination performed up to 12 weeks prior to screening if available.
• 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
• Infected with tuberculosis, (TB): Any evidence of untreated latent or active TB infection.
• Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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246 participants in 9 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

Induction - Placebo SC Q4W, (sub-cutaneous every 4 weeks) Chronic- PF-06480605 50 mg SC Q4W

Treatment:

Drug: Chronic- PF-06480605 50 mg SC Q4W

Other: Induction- Placebo SC Q4W

Cohort 2

Experimental group

Description:

Induction - Placebo SC Q4W, Chronic- PF-06480605 150 mg SC Q4W

Treatment:

Drug: Chronic- PF-06480605 150 mg SC Q4W

Other: Induction- Placebo SC Q4W

Cohort 3

Experimental group

Description:

Induction - Placebo SC Q4W, Chronic- PF-06480605 450 mg SC Q4W

Treatment:

Drug: Chronic- PF-06480605 450 mg SC Q4W

Other: Induction- Placebo SC Q4W

Cohort 4

Placebo Comparator group

Description:

Induction- PF-06480605 50 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W

Treatment:

Drug: Chronic- PF-06480605 50 mg SC Q4W

Drug: Induction- PF-06480605 50 mg SC Q4W

Cohort 5

Experimental group

Description:

Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W

Treatment:

Drug: Chronic- PF-06480605 50 mg SC Q4W

Drug: Induction- PF-06480605 150 mg SC Q4W

Cohort 6

Experimental group

Description:

Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W

Treatment:

Drug: Chronic- PF-06480605 150 mg SC Q4W

Drug: Induction- PF-06480605 150 mg SC Q4W

Cohort 7

Experimental group

Description:

Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W

Treatment:

Drug: Chronic- PF-06480605 50 mg SC Q4W

Drug: Induction- PF-06480605 450 mg SC Q4W

Cohort 8

Experimental group

Description:

Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W

Treatment:

Drug: Chronic- PF-06480605 150 mg SC Q4W

Drug: Induction- PF-06480605 450 mg SC Q4W

Cohort 9

Experimental group

Description:

Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 450 mg SC Q4W

Treatment:

Drug: Chronic- PF-06480605 450 mg SC Q4W

Drug: Induction- PF-06480605 450 mg SC Q4W