Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

Summary

The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.

Timeline

Start

2017-02-03

Primary completion

2021-05-10

Completion

2021-05-10

Outcome

Met primary endpoint

registry Placebo (Induction) vs PF-06700841 60 mg (Induction); p < 0.0001; Mean Difference (Final Values) -3.21 (90% CI -4.34 to -2.08) NCT02958865 ↗

paper The placebo-adjusted mean TMSs (90% confidence interval) at week 8 were -2.0 (-3.2 to -0.9), PMID 36623678 ↗

Publications

• Wojciechowski J, Mukherjee A, Banfield C, Nicholas T. Model-Informed Assessment of Probability of Phase 3 Success for Ritlecitinib in Patients with Moderate-to-Severe Ulcerative Colitis. Clin Pharmacol Ther. 2024 Sep;116(3):724-735. doi: 10.1002/cpt.3251. Epub 2024 Apr 16.
• Hassan-Zahraee M, Ye Z, Xi L, Dushin E, Lee J, Romatowski J, Leszczyszyn J, Danese S, Sandborn WJ, Banfield C, Gale JD, Peeva E, Longman RS, Hyde CL, Hung KE. Baseline Serum and Stool Microbiome Biomarkers Predict Clinical Efficacy and Tissue Molecular Response After Ritlecitinib Induction Therapy in Ulcerative Colitis. J Crohns Colitis. 2024 Sep 3;18(9):1361-1370. doi: 10.1093/ecco-jcc/jjad213.
• Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.
• Sandborn WJ, Danese S, Leszczyszyn J, Romatowski J, Altintas E, Peeva E, Hassan-Zahraee M, Vincent MS, Reddy PS, Banfield C, Salganik M, Banerjee A, Gale JD, Hung KE. Oral Ritlecitinib and Brepocitinib for Moderate-to-Severe Ulcerative Colitis: Results From a Randomized, Phase 2b Study. Clin Gastroenterol Hepatol. 2023 Sep;21(10):2616-2628.e7. doi: 10.1016/j.cgh.2022.12.029. Epub 2023 Jan 6.
• Fensome A, Ambler CM, Arnold E, Banker ME, Brown MF, Chrencik J, Clark JD, Dowty ME, Efremov IV, Flick A, Gerstenberger BS, Gopalsamy A, Hayward MM, Hegen M, Hollingshead BD, Jussif J, Knafels JD, Limburg DC, Lin D, Lin TH, Pierce BS, Saiah E, Sharma R, Symanowicz PT, Telliez JB, Trujillo JI, Vajdos FF, Vincent F, Wan ZK, Xing L, Yang X, Yang X, Zhang L. Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of (( S)-2,2-Difluorocyclopropyl)((1 R,5 S)-3-(2-((1-methyl-1 H-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841). J Med Chem. 2018 Oct 11;61(19):8597-8612. doi: 10.1021/acs.jmedchem.8b00917. Epub 2018 Aug 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brepocitinib	Small molecule	10 mg	Oral
Subject	Brepocitinib	Small molecule	30 mg	Oral
Subject	Brepocitinib	Small molecule	60 mg	Oral
Subject	Ritlecitinib	Small molecule	20 mg	Oral
Subject	Ritlecitinib	Small molecule	70 mg	Oral
Subject	Ritlecitinib	Small molecule	200 mg	Oral

Indications