A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

Conditions

• Crohn's Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mirikizumab — DRUG
  Administered Q4W

Study Details

The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.

Key Dates

First listed

Jan 18, 2020

Start date

Jun 22, 2020

Status verified

Nov 2025

Primary completion

Nov 28, 2024

Completion

Apr 30, 2027

Study Design

Enrollment

996 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: AMAM Mirikizumab (Miri): Miri 300 mg SC
  Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) for 52 weeks.
• Experimental: AMAM Miri: Miri 900 mg IV Then 300 mg SC
  Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg intravenously (IV) Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
• Experimental: AMAM Placebo (PBO)/Miri: Miri 300 mg SC
  Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.
• Experimental: AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC
  Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
• Experimental: AMAM Ustekinumab (Uste): Miri 300 mg SC
  Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.
• Experimental: AMAM Uste: Miri 900 mg IV Then 300 mg SC
  Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
• Experimental: AMAM PBO: Miri 300 mg SC
  Participants assigned to placebo in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.
• Experimental: AMAM PBO: Miri 900 mg IV Then 300 mg SC
  Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
• Experimental: All AMAG Participants: Miri 300 mg SC
  Participants from Study AMAG who continued into Study AMAX received mirikizumab 300 mg SC Q4W for 52 weeks.

Primary Outcome Measure

Percentage of Participants Achieving Endoscopic Response at Week 52 (Participants Originating From AMAM Study) [ Time Frame: Week 52 ]

Locations (54)

Find similar trials in Dothan, AL

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