Author, publication year, trial name
Study period
Study design; phase; funding
No. of centers, countries
Follow up N total rando mized N total rando mized
Key inclusion criteria
Primary outcomes
Primary outcomes
Intervention, N randomized
VDZ dose (mg)
Feagan et al, 2005, none Dec 2000-Feb 2003 randomized, double-blind, PBO-controlled study; n/a; none 20, 2 (USA, Canada) 6 wks 181 181 UCCS of 5-9 pts, with a score of atleast 1 on stool frequency or rectal bleeding, and MBS of at least 2 on sigmoidoscopy, with disease a minimum of 25cm from anal verge; no prior therapy or 5-ASA if given for >4 wks with stable dose for >2 wks At wk 6: UCCS of 0 or 1 and MBS of 0 or 1 without evidence of rectal bleeding At wk 6: UCCS of 0 or 1 and MBS of 0 or 1 without evidence of rectal bleeding Participants (n=181) were randomized 1:1:1 to receive low dose (n=58), high dose (n=60), or PBO (n=63) low dose: 0.5 mg/kg or high dose: 2 mg/kg
Feagan et al, 2013, GEMINI I 2008-2012 Randomized, double-blind, PBO-controlled; phase 3; Millennium Pharmaceuticals, Inc. 211, 34 52 wks 895 895 Moderately to severely active UC; demonstrated in the past 5 yrs inadequate response, loss of response, or intolerance to immunomodulators and/or TNFi and/or CS At wk 6: reduction in complete Mayo score of ≥ 3 pts and ≥30% from baseline with decrease in rectal bleeding subscore of ≥1 pt or absolute rectal bleeding subscore of ≤1 pt. At 52 wks: complete Mayo score of ≤2 pts and no individual subscore >1 pt At wk 6: reduction in complete Mayo score of ≥ 3 pts and ≥30% from baseline with decrease in rectal bleeding subscore of ≥1 pt or absolute rectal bleeding subscore of ≤1 pt. At 52 wks: complete Mayo score of ≤2 pts and no individual subscore >1 pt Induction Phase (wk 0-6): Cohort 1 (n=374) randomized and treated with double-blind VDZ (at wks 0,2), cohort 2 (n=521) treated with open-label VDZ (at wks 0,2). Maintenance phase (wk 6-52): VDZ-treated subjects cohort 1 and 2 who demonstrated CR (n=373) were randomized in a 1:1:1 ratio to double-blind Rx with VDZ q4w (n=125), VDZ administered q8w (n=122) or PBO (n=126); VDZ who did not respond at 6 wks continued open-label VDZ q4w (n=330) 300
Sandborn et al, 2013, GEMINI II Dec 2008-May 2012 Randomized, double-blind, PBO-controlled; phase 3; Millennium Pharmaceuticals, Inc. 285 centers, 39 countries 52 wks 52 wks 1115 Moderately to severely active CD; involvement of the ileum and/or colon; demonstrated in the past 5 yrs inadequate response, loss of response, or intolerance to immunomodulators and/or TNFi and/or CS At wk 6: % of subjects achieving CDAI <150 at wk 6; % of subjects with CDAI 100 pts below baseline. At wk 52: % of subjects with CDAI <150 at 52 wks At wk 6: % of subjects achieving CDAI <150 at wk 6; % of subjects with CDAI 100 pts below baseline. At wk 52: % of subjects with CDAI <150 at 52 wks Induction Phase (wk 0-6): Cohort 1 (n=368) randomized and treated with double-blind VDZ (at wks 0,2), cohort 2 (n=747) treated with open-label VDZ (at wks 0,2). Maintenance phase (wks 6-52): VDZ-treated subjects cohort 1 and 2 who demonstrated CR (n=461) were randomized in a 1:1:1 ratio to double-blind RX with VDZ q4w (n=154), VDZ administered q8w (n=154) or PBO (n=153); VDZ who did not respond at wk 6 continued open-label VDZ q4w (n=412) 300
Sands et al, 2014, GEMINI III Nov 2010-Apr 2012 Randomized, double-blind, PBO-controlled; phase 3; Takeda Pharmaceuticals International, Inc. 107, ? (listed continents: North America, Europe, Asia, Africa, and Australia) 16 wks 16 wks 416 Moderately to severely active CD; involvement of the ileum and/or colon; demonstrated in the past 5 yrs inadequate response, loss of response, or intolerance to imunosuppressives and/or TNFi and/or CS At wk 6: % of subjects within TNFi failure population with CDAI <150 At wk 6: % of subjects within TNFi failure population with CDAI <150 Participants (n=416) were randomized 1:1 to receive VDZ (n=209) or PBO (n=207) at wks 0,2,6 300
Motoya et al, 2019, none Feb 2014-Jun 2018 Takeda Pharmaceutical Company Limited 100, 1 (Japan) 76 wks 76 wks 292 Total or L sided UC atleast 6m prior to study; moderately or severely active UC; meet failure criteria to atleast 1 of the following in prior 5y: CS, AZA or 6-MP, TNFi At wk 10: reduction in complete Mayo score of ≥3 pts and ≥30% from baseline with decrease in rectal bleeding subscore of ≥1 pt or absolute rectal bleeding subscore of ≤1 pt; at wk 60: complete Mayo score of ≤2 pts and no individual subscore >1 pt Induction phase (wks 0-10): Cohort 1 (n=246) was randomized 2:1 to receive VDZ (n=164) or PBO (n=82), cohort 2 (n=46) received VDZ only at wks 0,2,6; subjects showing CR to VDZ at wk 10 (n=83) were randomized 1:1 to receive VDZ (n=41) or PBO (n=42) at wk 14 then q8w up to 54 wks Induction phase (wks 0-10): Cohort 1 (n=246) was randomized 2:1 to receive VDZ (n=164) or PBO (n=82), cohort 2 (n=46) received VDZ only at wks 0,2,6; subjects showing CR to VDZ at wk 10 (n=83) were randomized 1:1 to receive VDZ (n=41) or PBO (n=42) at wk 14 then q8w up to 54 wks 300