Table 2.

Summary of Emerging Therapies That Have Completed Phase III Trials

Agent	Target	Mode of Delivery	Dose	Primary Endpoint	Primary Endpoint (Drug vs Placebo)
CT-P13	TNF	SC	120 mg Q2WK	LIBERTY-UC: Clinical remission at WK 52	43.2% vs 20.8% (p<0.001)
Etrolizumab	α4β7 and αEβ7 integrins	SC	105 mg Q4WK	HICKORY: Clinical remission WK14 HICKORY: Clinical remission WK 66 HIBISCUS I: Clinical remission WK10 HIBISCUS II: Clinical remission WK10	18.5% vs 6.3% (p=0.003) 24.1% vs 20.2% (p=0.50) 19.4% vs 6.9% (p=0.017) 18.2% vs (11.1%) (p=0.17)
Carotegrast methyl (AJM300)	α4 integrin	Oral	960 mg TID	Clinical response WK8	45% vs 21% (p<0.001)
Mirikizumab	IL23/p19 subunit	IV (induction) SC (maintenance)	Induction: 300 mg Q4WK Maintenance: 200 mg Q4WK	LUCENT 1: Clinical remission WK12 LUCENT 2: Clinical remission WK40	24.2% vs 13.3% (p<0.001) 49.9% vs 25.1% (p<0.001)
Upadacitinib	JAK1	Oral	Induction: 45 mg daily Maintenance: 15–30 mg daily	U-ACHIEVE: Clinical remission WK8 U-ACCOMPLISH: Clinical remission WK 8 U-ACHIEVE (Maintenance): Clinical remission WK52	26% vs 5% (p<0.001) 33% vs 4% (p<0.001) 52% (30 mg) vs 12% (p<0.001) 42% (15 mg) vs 12% (p>0.001)
Etrasimod	S1PR1, S1PR4 and S1PR5	Oral	2 mg daily	ELEVATE UC 12: Clinical remission WK12 ELEVATE UC 52: Clinical remission WK12 ELEVATE UC 52: Clinical remission WK52	25% vs 15% (p=0.026) 27% vs 7% (p<0.001) 32% vs 7% (p<0.001)

Note: Bold= primary endpoint met.

Abbreviations: TNF, tumor necrosis factor; α4β7, alpha4-beta7; αEβ7, alphaE-beta7; α4, alpha4; IL-23, interleukin 23; JAK, janus kinase; S1PR, sphingosine 1 phosphate receptor; SC, subcutaneous; IV, intravenous; Q2WK, every 2 weeks; Q4WK, every 4 weeks; TID, three times a day; WK, week; UC, ulcerative colitis.