Moderate to severe ulcerative colitis
Conditions
Interventions
investigational material(s)
Generic name etc : PF-06480605
INN of investigational material : afimkibart
Therapeutic category code : 239 Other agents affecting digestive organs
Dosage and Administratio
Sponsors
Chugai Pharmaceutical Co., Ltd.
F. Hoffmann-La Roche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy 1. Proportion of participants achieving clinical remission at Week 14. 2. Incidence and severity of treatment emergent adverse events (TEAEs) during the induction period. 3. Incidence of serious adverse events (SAEs) during the induction period. 4. Incidence of AEs or SAEs leading to discontinuation during the induction period. 5. Incidence of clinically significant abnormalities in vital signs, electrocaridograms, (ECGs) and laboratory values during the induction period. *Time Frames of 1 to 5 above are weeks 0-14 6. Incidence and severity of treatment emergent adverse events (TEAEs) during the chronic therapy period. 7. Incidence of serious adverse events (SAEs) during the chronic therapy period. 8. Incidence of AEs or SAEs leading to discontinuation during the chronic therapy period. 9. Incidence of clinically significant abnormalities in vital signs, ECGs and laboratory values during the chronic therapy period. *Time frames of 6 to 9 are weeks 14-64 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics 1. Proportion of participants achieving remission Food and Drug Administration, (FDA definition 1 ) at Week 14. 2. Proportion of participants achieving remission (FDA definition 2) at Week 14. 3. Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore = 0 or 1) at Week 14. 4. Proportion of participants achieving endoscopic remission (defined as endoscopic subscore = 0) at Week 14. 5. PF-06480605 trough concentrations during the induction period through Week 14. 6. Change from screening in fecal calprotectin during the induction period through Week 14. 7. Change from baseline in hsCRP during the induction period through Week 14. 8. Change from baseline in serum sTL1A during the induction period through Week 14. 9. Incidence of development of anti drug antibodies (ADAs) and neutralizing antibodies (NAbs) during the induction period through Week 14. | — |
Countries
Australia, Belgium, Bulgaria, Colombia, France, Germany, Hungary, India, Italy, Japan, Mexico, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Thailand, Turkey, UK, Ukraine, US
Outcome results
None listed