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Monoclonal Antibodies

Cohort 8 for Ulcerative Colitis

Phase 2
Waitlist Available
Research Sponsored by Telavant, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 14-64
Awards & highlights

Study Summary

This trial will compare different doses of a new drug against a placebo, in order to see if the drug is effective. All subjects will receive the active drug for 40 weeks after the initial 12 week induction period.

Eligible Conditions
  • Ulcerative Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 14-64
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 14-64 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Incidence and severity of treatment emergent adverse events (TEAEs) during the induction period.
Incidence of AEs or SAEs leading to discontinuation during the chronic therapy period.
+6 more
Secondary outcome measures
Change from Week 14 in fecal calprotectin during the chronic therapy period through the End of Study Visit
Change from Week 14 in hsCRP during the chronic therapy period through the End of Study Visit.
Change from baseline in fecal calprotectin during the induction period through Week 14.
+23 more

Trial Design

9Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 9Experimental Treatment2 Interventions
Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 450 mg SC Q4W
Group II: Cohort 8Experimental Treatment2 Interventions
Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W
Group III: Cohort 7Experimental Treatment2 Interventions
Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W
Group IV: Cohort 6Experimental Treatment2 Interventions
Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W
Group V: Cohort 5Experimental Treatment2 Interventions
Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W
Group VI: Cohort 3Experimental Treatment2 Interventions
Induction - Placebo SC Q4W, Chronic- PF-06480605 450 mg SC Q4W
Group VII: Cohort 2Experimental Treatment2 Interventions
Induction - Placebo SC Q4W, Chronic- PF-06480605 150 mg SC Q4W
Group VIII: Cohort 1Experimental Treatment2 Interventions
Induction - Placebo SC Q4W, (sub-cutaneous every 4 weeks) Chronic- PF-06480605 50 mg SC Q4W
Group IX: Cohort 4Placebo Group2 Interventions
Induction- PF-06480605 50 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chronic- PF-06480605 450 mg SC Q4W
2019
Completed Phase 2
~250
Chronic- PF-06480605 50 mg SC Q4W
2019
Completed Phase 2
~250
Induction- PF-06480605 150 mg SC Q4W
2019
Completed Phase 2
~250
Chronic- PF-06480605 150 mg SC Q4W
2019
Completed Phase 2
~250
Induction- PF-06480605 450 mg SC Q4W
2019
Completed Phase 2
~250

Find a Location

Who is running the clinical trial?

Telavant, Inc.Lead Sponsor
5 Previous Clinical Trials
178 Total Patients Enrolled
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,822 Total Patients Enrolled
9 Trials studying Ulcerative Colitis
3,766 Patients Enrolled for Ulcerative Colitis
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,908,055 Total Patients Enrolled
33 Trials studying Ulcerative Colitis
426,017 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis
2019. "A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04090411.
~47 spots leftby Apr 2025
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