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. 2019 May;15(5):255–265.

Table.

Ongoing Clinical Trials on Selective Anti–Interleukin-23 Monoclonal Antibodies

Drug (Trial Sponsor) ClinicalTrials. gov Identifier Clinical Indication Active Comparator Design Primary Endpoint
Guselkumab (Janssen) NCT03466411 CD Ustekinumab Phase 2/3, randomized, double-blind, placebo- and active-controlled, parallel-group studies:

  • – 48-week, phase 2, dose-ranging study (GALAXI 1)

  • – Two 48-week, phase 3 studies (GALAXI 2 and 3)

  • – Long-term extension study: if phase 2 or 3 trials completed

 Phase 2: Change from baseline in CDAI score at week 12
Phase 3: Clinical remission at week 12. CDAI score <150
NCT03662542 UC Golimumab Phase 2a, randomized, double-blind, active-controlled, parallel-group, multicenter, proof-of-concept study:

  • – Combination therapy: guselkumab and golimumab

  • – Monotherapy: guselkumab or golimumab

 Clinical response (as defined by Mayo score) at week 12
Risankizumab (AbbVie) NCT03105128 CD None Phase 3, randomized, double-blind, placebo-controlled induction study (M16-006) Percentage of participants at week 12 with:

  • – Endoscopic response

  • – Clinical remission
NCT03104413 CDa None Phase 3, randomized, double-blind, placebo-controlled induction study (M15-991) Percentage of participants at week 12 with:

  • – Endoscopic response

  • – Clinical remission
NCT02513459 CD None Open-label, single-group, long-term safety extension Incidence of drug-related adverse events
NCT03105102 CD None Subjects who responded to induction in M16-006 or M15-991:

  • – Substudy 1: randomized, double-blind, placebo-controlled study; maintenance therapy

  • – Substudy 2: randomized, exploratory maintenance study with 2 different doses

Subjects who completed substudy 1 or 2 or the phase 2, open-label extension study:

  • – Substudy 3: Open-label, long-term extension study

 Percentage of participants at week 52 with:

  • – Endoscopic response

  • – Clinical remission
NCT03398148 UCb None Randomized, double-blind, placebo-controlled induction study Percentage of participants at week 12 with:

  • – Clinical remission (Mayo score)
NCT03398135 UCb None Subjects who responded to induction:

  • – Substudy 1: 52-week, randomized, double-blind, placebo-controlled maintenance study

  • – Substudy 2: 52-week, randomized, exploratory maintenance study

  • – Substudy 3: open-label, long-term extension study (completed substudy 1 or 2)

 Percentage of participants at week 52 with:

  • – Clinical remission (Mayo score)
Brazikumab (Allergan) NCT03759288 CD Adalimumab 52-week, randomized, double-blind, double-dummy, placebo- and active-controlled, operationally seamless phase 2b/3, parallel-group study:

  • – Stage 1: vs placebo

  • – Stage 2: vs adalimumab

 Percentage of participants with endoscopic response and clinical remission:

  • – Stage 1: week 12

  • – Stage 2: week 52
NCT03616821 UC Vedolizumab 54-week, randomized, double-blind, double-dummy, placebo- and active-controlled, parallel-group, phase 2 study Clinical remission based on modified Mayo score at week 10
Mirikizumab (Eli Lilly) NCT02891226 CD None Phase 2, randomized, parallel-arm, placebo-controlled study (SERENITY) Proportion of participants achieving 50% reduction from baseline on the SESCD at week 12
NCT03518086 UCc None Phase 3, randomized, double-blind, parallel-arm, placebo-controlled induction study (LUCENT 1) Percentage of participants at week 12 with:

  • – Clinical remission (modified Mayo score)
NCT03524092 UCc None Phase 3, randomized, double-blind, parallel-arm, placebo-controlled maintenance study (completed LUCENT 1) Percentage of participants at week 40 with:

  • – Clinical remission (modified Mayo score)
NCT03519945 UCc None Phase 3, open-label extension study:

  • – Long-term efficacy and safety

 Percentage of participants at week 52 with:

  • – Clinical remission (modified Mayo score)
a

Patients with intolerance or inadequate response to biologic therapy; excluded were patients with prior exposure to p19 inhibitors.

b

Patients with intolerance or inadequate response to biologic therapy.

c

Patients with intolerance or inadequate response to biologic therapy; excluded were patients with prior exposure to p40 or p19 inhibitors.

CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; SES-CD, Simplified Endoscopic Activity Score for Crohn’s Disease; UC, ulcerative colitis.