A Study of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis

Phase 2

Active, not recruiting

Conditions: Ulcerative (chronic) pancolitis, (2) ICD-10 Condition: K512||Ulcerative (chronic) proctitis, (3) ICD-10 Condition: K513||Ulcerative (chronic) rectosigmoiditis, (4) ICD-10 Condition: K515||Left sided colitis,

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.

Recruitment & Eligibility

Inclusion Criteria

(1) A diagnosis of UC for â‰¥3 months.
(2)Participants with moderate to severe active UC as defined by a Total Mayo Score of â‰¥6, and an endoscopic subscore of â‰¥2.
(3)Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy).
(4)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

(1)Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohns disease (eg, skip lesions, fistulae or perianal disease, non necrotizing granulomas, etc.).
(2)Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study (3) Chest Radiograph showing abnormalities i.e. 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.
(4)12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (5)Infected with tuberculosis i.e. any evidence of untreated latent or active TB infection.
(6)Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses.

Primary Outcome Measures

Name	Time	Method
1. Proportion of participants achieving clinical remission (defined as a Total Mayo Score lesser than or equal to 2, with no individual subscore greater than 1) at Week 14. Safety and tolerability will also be assessed.	week 0-14
2.Incidence and severity of treatment emergent adverse events during the induction period.	week 0-14
3.Incidence of serious adverse events during the induction period.	week 0-14
4.Incidence of AEs or SAEs leading to discontinuation during the induction period.	week 0-14

Secondary Outcome Measures

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

Locations (8): All India Institute of Medical Sciences
🇮🇳
Delhi, DELHI, India
Gujarat Hospital â€“ Gastro and Vascular Centre
🇮🇳
Surat, GUJARAT, India
Kasturba Medical College and Hospital
🇮🇳
Udupi, KARNATAKA, India
M.S. Ramaiah Medical College and Hospitals
🇮🇳
Bangalore, KARNATAKA, India
S. R. Kalla Memorial Gastro and General Hospital
🇮🇳
Jaipur, RAJASTHAN, India
Shree Giriraj Multispecialty Hospital
🇮🇳
Rajkot, GUJARAT, India
SMS Medical College and Hospital
🇮🇳
Jaipur, RAJASTHAN, India
Surat Institute of Digestive Sciences
🇮🇳
Surat, GUJARAT, India
All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
Dr Saurabh Kedia
Principal investigator
9868428535
dr.saurabhkedia@yahoo.com