A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)
Inclusion Criteria:
Participants with Ulcerative Colitis (UC):
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 been enrolled previously in study SHP647-301 (NCT03259334), SHP647-302 (NCT03259308), and are in the treatment period of Study SHP647-303, completed the early termination (ET) or Week 52 visit in maintenance study SHP647-303 (NCT03290781), had responded to ontamalimab treatment (in the induction and/or maintenance studies), and meet one of the following criteria:
a. Participants are on placebo at the maintenance study ET or Week 52 visit: they received ontamalimab in the induction studies and fulfilled the maintenance study response criteria, OR b. Participants have received ontamalimab at the maintenance study ET or Week 52 visit: i) Clinical composite score that has decreased by >or=2 points and >or=30%, with an accompanying decrease in the subscore for RB >or=1 point or a subscore for RB <or=1, compared to the baseline value for induction studies, and/or ii) Composite score that has decreased by >or=30% and >or=3 points compared to the baseline value for induction studies.
Participants receiving any treatment(s) for UC are eligible provided they have been on a stable dose for the designated period of time.
Participants with Crohn's Disease:
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 been enrolled previously in Study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and are in the treament period of Study SHP647-307 (NCT03627091), completed the ET or Week 52 visit in maintenance study SHP647-307, had responded to ontamalimab treatment (in the induction or maintenance studies) and meet one of the following criteria:
i) CDAI score that has decreased by >or=100 points at EOT visit compared to the baseline value for induction studies, and/or ii) SES-CD that has decreased by >or=25% compared to the baseline value for induction studies.
Participants receiving any treatment(s) for CD are eligible provided they have been on a stable dose for the designated period of time.
Exclusion Criteria:
Participants with UC:
Participants with Crohn's Disease:
Columbus, Georgia 31904, United States
Oklahoma City, Oklahoma 73104, United States
Pittsburgh, Pennsylvania 15240, United States
Garland, Texas 75044, United States
Webster, Texas 77598, United States
Sofia, Sofia-Grad 1784, Bulgaria
Pleven, 5800, Bulgaria
Rousse, 7002, Bulgaria
Sofia, 1527, Bulgaria
Ústí nad Labem, 401 13, Czechia
Kohta-Järve, 31025, Estonia
Berlin-Zehlendorf, 14163, Germany
Paliao Faliro, 17562, Greece
Bologna, Emilia-Romagna 40138, 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
Włocławek, Kuyavian-Pomeranian Voivodeship 87-800, Poland
Lódz, Lódzkie 90-302, Poland
Lódz, Lódzkie 90-647, Poland
Lódz, Lódzkie 93-338, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Katowice, Silesian Voivodeship 40-211, Poland
Krakow, 31-315, Poland
Poznan, Poland
Gmina Końskie, Świętokrzyskie Voivodeship 26-200, Poland
Smoensk, 214018, Russia
Chernivtsi, Chernivtsi Oblast 58001, Ukraine
Kharkiv, Kharkiv Oblast 61037, 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
Kyiv, 04107, Ukraine
Lviv, 79007, Ukraine
Lviv, 79059, Ukraine
Odesa, 65025, Ukraine
Vinnytsia, 21018, Ukraine
Lancashire, Bury BL9 7TD, United Kingdom
Edinburh, EH4 2XU, United Kingdom