Phase 2
N=246
A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis
Moderate to Severe Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT04090411 ↗Enrolled (actual)
246
Serious AEs
5.3%
Results posted
Dec 2025
Primary outcome: Primary: Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14 — 11.6; 25.5; 23.3; 23.9 percentage of participants — p=0.0545
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Induction- PF-06480605 50 mg SC Q4W (Drug); Induction- PF-06480605 150 mg SC Q4W (Drug); Induction- PF-06480605 450 mg SC Q4W (Drug); Induction- Placebo SC Q4W (Other); Chronic- PF-06480605 50 mg SC Q4W (Drug); Chronic- PF-06480605 150 mg SC Q4W (Drug); Chronic- PF-06480605 450 mg SC Q4W (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14 |
11.6; 25.5; 23.3; 23.9 | 0.0545 |
| PRIMARY Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
25; 16; 29; 49 | — |
| PRIMARY Induction Period: Number of Participants With Serious Adverse Events (SAEs) |
4; 3; 1; 4 | — |
| PRIMARY Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation |
0; 0; 0; 0 | — |
| PRIMARY Chronic Period: Number of Participants With TEAEs |
5; 9; 9; 30; 16; 15 | — |
| PRIMARY Chronic Period: Number of Participants With SAEs |
0; 0; 0; 5; 1; 0 | — |
| PRIMARY Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1) |
7.0; 14.9; 13.3; 14.8; 16.7; 23.1 | 0.1398 |
| SECONDARY Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2) |
11.6; 29.8; 35.0; 31.8; 50.0; 30.8 | 0.0189 sig |
| SECONDARY Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement |
18.6; 40.4; 38.3; 40.9; 66.7; 38.5 | 0.0146 sig |
| SECONDARY Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission |
7.0; 19.1; 10.0; 10.2; 16.7; 23.1 | 0.0489 sig |
| SECONDARY Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 |
NA; 1.227; 1.279; 2251; 6568; 19660 | — |
| SECONDARY Induction Period: Change From Baseline in Fecal Calprotectin |
10.62; 9.99; 10.78; 10.23; -0.32; -0.38 | — |
| SECONDARY Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) |
1.76; 1.47; 1.41; 1.82; -0.49; -0.48 | — |
| SECONDARY Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) |
6.86; 6.74; 6.77; 6.83; 0.01; 3.45 | — |
| SECONDARY Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 |
0; 1; 2; 0; 0; 29 | — |
| SECONDARY Chronic Period: Percentage of Participants Who Achieved Clinical Remission |
33.3; 38.5; 35.7; 31.0; 29.6; 34.6 | — |
| SECONDARY Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission |
0; 25.0; 50.0; 50.0; 62.5; 28.6 | — |
| SECONDARY Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 1 (Modified Remission 1) |
33.3; 28.6; 40.0; 66.7; 25.0; 0 | — |
| SECONDARY Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2) |
0; 0; 33.3; 42.9; 70.0; 54.5 | — |
| SECONDARY Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement |
50.0; 0; 25.0; 47.4; 80.0; 61.5 | — |
| SECONDARY Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission |
0; 0; 22.2; 50.0; 25.0; 66.7 | — |
| SECONDARY Chronic Period: Change From Week 16 in Fecal Calprotectin |
10.22; 9.28; 9.77; 8.86; 9.03; 7.72 | — |
| SECONDARY Chronic Period: Change From Week 14 in hsCRP |
1.22; 2.49; 0.43; 0.72; 0.26; 0.11 | — |
| SECONDARY Chronic Period: Change From Week 14 in Serum sTL1A |
6.84; 7.21; 6.67; 9.78; 10.71; 10.61 | — |
| SECONDARY Change From Baseline in Fecal Calprotectin Through the End of Study |
10.43; 11.06; 10.44; 9.91; 11.12; 10.38 | — |
| SECONDARY Change From Baseline in hsCRP Through the End of Study |
2.08; 2.41; 0.86; 1.42; 1.35; 1.22 | — |
| SECONDARY Change From Baseline in Serum sTL1A Through the End of Study |
6.76; 6.93; 6.89; 6.73; 6.77; 6.69 | — |
| SECONDARY Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 |
0; 0; 0; 38; 18; 24 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04090411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.