A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)
A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)
The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
Inclusion Criteria:
Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
Participants must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study.
Participants must have completed the 12-week induction treatment period (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
Participants must have achieved clinical response in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). Clinical response is defined as:
i) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in the composite score of patient reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub score for rectal bleeding greater than or equal to (>=) 1 point or a sub score for rectal bleeding less than or equal to (<=) 1 OR ii) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1.
For eligibility assessment, clinical response will be determined based on the centrally read endoscopy performed during screening and at Week 12 of induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
- Participants receiving any treatment(s) for ulcerative colitis (UC) are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
Exclusion Criteria:
Columbus, Georgia 31904, United States
Oklahoma City, Oklahoma 73104, United States
Pittsburgh, Pennsylvania 15240, United States
Baytown, Texas 77521, United States
Garland, Texas 75044, United States
Sofia, Sofia-Grad 1784, Bulgaria
Pleven, 5800, Bulgaria
Rousse, 7002, Bulgaria
Sofia, 1527, Bulgaria
Ústi Nad Orlici, 562 18, Czechia
Ústí nad Labem, 401 13, Czechia
Kohta-Järve, 31025, Estonia
Berlin-Zehlendorf, 14163, Germany
Bologna, Emilia-Romagna 40138, Italy
Padova, Veneto 35128, Italy
Nishinomiya-shi, Hyôgo 663-8501, Japan
Chuo-Ku, Tokyo 103-0028, Japan
Minato-ku, Tokyo 105-8471, Japan
Minato-ku, Tokyo 108-8642, Japan
Kurume-shi, 839-0809, Japan
Matsumoto-shi, 390-0814, Japan
Shimotsuga-gun, 321-0293, Japan
Torun, Kuyavian-Pomeranian Voivodeship 87-100, Poland
Włocławek, Kuyavian-Pomeranian Voivodeship 87-800, Poland
Lódz, Lódzkie 90-302, Poland
Lódz, Lódzkie 90-647, Poland
Lódz, Lódzkie 93-338, Poland
Katowice, Silesian Voivodeship 40-211, Poland
Szczecin, West Pomeranian Voivodeship 71-434, Poland
Krakow, 31-315, Poland
Poznan, 60-856, Poland
Gmina Końskie, Świętokrzyskie Voivodeship 26-200, Poland
Chernivtsi, Chernivtsi Oblast 58001, Ukraine
Kharkiv, Kharkiv Oblast 61037, Ukraine
Kyiv, Kyïv 04107, Ukraine
Vinnytsia, Vinnytsia Oblast 21018, Ukraine
Zaporizhzhya, Zaporizhzhia Oblast 69005, Ukraine
Dnipro, 49005, Ukraine
Dnipro, 49074, Ukraine
Kharkiv, 61058, Ukraine
Kharkiv, 61166, Ukraine
Kherson, 73000, Ukraine
Kryvyi Rih, 50056, Ukraine
Lviv, 79007, Ukraine
Odesa, 65025, Ukraine
Vinnytsia, 21018, Ukraine
Lancashire, Bury BL9 7TD, United Kingdom
Edinburh, EH4 2XU, United Kingdom