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

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ClinicalTrials.gov Identifier: NCT04090411
Recruitment Status : Completed
First Posted : September 16, 2019
Last Update Posted : January 19, 2024
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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: Induction- PF-06480605 50 mg SC Q4W Drug: Induction- PF-06480605 150 mg SC Q4W Drug: Induction- PF-06480605 450 mg SC Q4W Other: Induction- Placebo SC Q4W Drug: Chronic- PF-06480605 50 mg SC Q4W Drug: Chronic- PF-06480605 150 mg SC Q4W Drug: Chronic- PF-06480605 450 mg SC Q4W Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 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
Actual Study Start Date : December 19, 2019
Actual Primary Completion Date : October 25, 2022
Actual Study Completion Date : October 25, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
Induction - Placebo SC Q4W, (sub-cutaneous every 4 weeks) Chronic- PF-06480605 50 mg SC Q4W
 Other: Induction- Placebo SC Q4W
0 mg Placebo

Drug: Chronic- PF-06480605 50 mg SC Q4W
PF-06480605
Experimental: Cohort 2
Induction - Placebo SC Q4W, Chronic- PF-06480605 150 mg SC Q4W
 Other: Induction- Placebo SC Q4W
0 mg Placebo

Drug: Chronic- PF-06480605 150 mg SC Q4W
PF-06480605
Experimental: Cohort 3
Induction - Placebo SC Q4W, Chronic- PF-06480605 450 mg SC Q4W
 Other: Induction- Placebo SC Q4W
0 mg Placebo

Drug: Chronic- PF-06480605 450 mg SC Q4W
PF-06480605
Placebo Comparator: Cohort 4
Induction- PF-06480605 50 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W
 Drug: Induction- PF-06480605 50 mg SC Q4W
PF-06480605

Drug: Chronic- PF-06480605 50 mg SC Q4W
PF-06480605
Experimental: Cohort 5
Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W
 Drug: Induction- PF-06480605 150 mg SC Q4W
PF-06480605

Drug: Chronic- PF-06480605 50 mg SC Q4W
PF-06480605
Experimental: Cohort 6
Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W
 Drug: Induction- PF-06480605 150 mg SC Q4W
PF-06480605

Drug: Chronic- PF-06480605 150 mg SC Q4W
PF-06480605
Experimental: Cohort 7
Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W
 Drug: Induction- PF-06480605 450 mg SC Q4W
PF-06480605

Drug: Chronic- PF-06480605 50 mg SC Q4W
PF-06480605
Experimental: Cohort 8
Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W
 Drug: Induction- PF-06480605 450 mg SC Q4W
PF-06480605

Drug: Chronic- PF-06480605 150 mg SC Q4W
PF-06480605
Experimental: Cohort 9
Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 450 mg SC Q4W
 Drug: Induction- PF-06480605 450 mg SC Q4W
PF-06480605

Drug: Chronic- PF-06480605 450 mg SC Q4W
PF-06480605


Outcome Measures
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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 ]
  6. Incidence and severity of treatment emergent adverse events (TEAEs) during the chronic therapy period. [ Time Frame: Weeks 14-64 ]
  7. Incidence of serious adverse events (SAEs) during the chronic therapy period. [ Time Frame: Weeks 14-64 ]
  8. Incidence of AEs or SAEs leading to discontinuation during the chronic therapy period. [ Time Frame: Weeks 14-64 ]
  9. Incidence of clinically significant abnormalities in vital signs, ECGs and laboratory values during the chronic therapy period. [ Time Frame: Weeks 14-64 ]

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 ]
  10. Proportion of participants achieving clinical remission (defined as a Total Mayo Score >/= to 2, with no individual subscore >1) at Week 56. [ Time Frame: Weeks 14-56 ]
  11. Proportion of participants achieving sustained clinical remission (ie, clinical remission at both Week 14 and Week 56). [ Time Frame: Weeks 14-56 ]
  12. Proportion of participants achieving remission (FDA definition 1 - defined as endoscopic subscore = 0 or 1, stool frequency subscore = 0, and rectal bleeding subscore = 0) at Week 56. [ Time Frame: Weeks 14-56 ]
  13. Proportion of participants achieving sustained remission-FDA definition 1 (ie, remission-FDA definition 1 at both Week 14 and Week 56). [ Time Frame: Weeks 14-56 ]
  14. Proportion of participants achieving sustained remission-FDA definition 2 (ie, remission-FDA definition 2 at both Week 14 and Week 56). [ Time Frame: Weeks 14-56 ]
  15. Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore = 0 or 1) at Week 56. [ Time Frame: Weeks 14-56 ]
  16. Proportion of participants achieving sustained endoscopic improvement (ie, endoscopic improvement at both Week 14 and Week 56). [ Time Frame: Weeks 14-56 ]
  17. Proportion of participants achieving endoscopic remission (defined as endoscopic sub-score = 0) at Week 56. [ Time Frame: Weeks 14-56 ]
  18. Proportion of participants achieving sustained endoscopic remission (ie, endoscopic remission at both Week 14 and Week 56). [ Time Frame: Weeks 14-56 ]
  19. PF-06480605 concentration from Week 14 through the End of Study Visit. [ Time Frame: Weeks 14-64 ]
  20. Change from Week 14 in fecal calprotectin during the chronic therapy period through the End of Study Visit [ Time Frame: Weeks 14-64 ]
  21. Change from Week 14 in hsCRP during the chronic therapy period through the End of Study Visit. [ Time Frame: Weeks 14-64 ]
  22. Change from week 14 in serum sTL1A during the chronic therapy period through the End of Study Visit. [ Time Frame: Weeks 14-64 ]
  23. Change from baseline through the End of the Study Visit in fecal calprotectin [ Time Frame: weeks 14-64 ]
  24. Change from baseline through the End of the Study Visit in hsCRP. [ Time Frame: Weeks 14-64 ]
  25. Change from baseline through the End of Study Visit in serum sTL1A. [ Time Frame: Weeks 14-64 ]
  26. Incidence of development of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) from Week 14 through the End of Study Visit. [ Time Frame: Weeks 14-64 ]

Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04090411    
Other Study ID Numbers: B7541007
TL1A ( Other Identifier: Alias Study Number )
Tuscany 2 ( Other Identifier: Alias Study Number )
2019-002698-74 ( EudraCT Number )
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: January 19, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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