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

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ClinicalTrials.gov Identifier: NCT04090411
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Moderate to Severe Ulcerative Colitis Drug: 50 mg Drug: 450 mg Drug: 150 mg Other: 0 mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
Estimated Study Start Date : November 22, 2019
Estimated Primary Completion Date : July 24, 2023
Estimated Study Completion Date : July 24, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 450 mg
PF-06480605
Drug: 450 mg
PF-06480605

Experimental: 150 mg
PF-06480605
Drug: 150 mg
PF-06480605

Experimental: 50 mg
PF-06480605
Drug: 50 mg
PF-06480605

Placebo Comparator: 0 mg Other: 0 mg
0 mg Placebo




Primary Outcome Measures :
  1. Proportion of participants achieving clinical remission (defined as a Total Mayo Score ≤2, with no individual subscore >1) at Week 14. Safety and tolerability will also be assessed [ Time Frame: week 0-14 ]
  2. Incidence and severity of treatment emergent adverse events (TEAEs) during the induction period. [ Time Frame: week 0-14 ]
  3. Incidence of serious adverse events (SAEs) during the induction period. [ Time Frame: week 0-14 ]
  4. Incidence of AEs or SAEs leading to discontinuation during the induction period. [ Time Frame: week 0-14 ]
  5. Incidence of clinically significant abnormalities in vital signs, electrocaridograms, (ECGs) and laboratory values during the induction period. [ Time Frame: week 0-14 ]

Secondary Outcome Measures :
  1. Proportion of participants achieving remission Food and Drug Administration, ((FDA) definition 1 - defined as endoscopic subscore = 0 or 1, stool frequency subscore = 0, and rectal bleeding subscore = 0) at Week 14. [ Time Frame: week 0-14 ]
  2. Proportion of participants achieving remission (FDA definition 2 - defined as endoscopic subscore = 0 or 1, ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 or 1, and rectal bleeding subscore = 0) at Week 14. [ Time Frame: week 0-14 ]
  3. Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore = 0 or 1) at Week 14. [ Time Frame: week 0-14 ]
  4. Proportion of participants achieving endoscopic remission (defined as endoscopic subscore = 0) at Week 14. [ Time Frame: week 0-14 ]
  5. PF 06480605 trough concentrations during the induction period through Week 14. [ Time Frame: week 0-14 ]
  6. Change from baseline in fecal calprotectin during the induction period through Week 14. [ Time Frame: week 0-14 ]
  7. Change from baseline in hsCRP during the induction period through Week 14. [ Time Frame: week 0-14 ]
  8. Change from baseline in serum sTL1A during the induction period through Week 14. [ Time Frame: week 0-14 ]
  9. Incidence of development of anti drug antibodies (ADAs) and neutralizing antibodies (NAbs) during the induction period through Week 14. [ Time Frame: week 0-14 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090411


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04090411     History of Changes
Other Study ID Numbers: B7541007
TL1A ( Other Identifier: Alias Study Number )
Tuscany 2 ( Other Identifier: Alias Study Number )
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases