Cure8 trial brief
Long-term extension trials help show whether a drug’s benefits and safety persist over time. For people with Crohn’s disease, this study focuses on maintaining endoscopic improvement and clinical remission with mirikizumab.
If mirikizumab is effective and well tolerated long-term, it could expand treatment options for patients who responded in the originating studies.
Adult patients with Crohn’s disease who completed prior mirikizumab or ustekinumab trials, clinicians treating moderate-to-severe Crohn’s disease, researchers studying biologic therapies and long-term safety, and patients interested in biologic treatment continuation studies.
This is a ClinicalTrials.gov record for AMAX, a Phase 3 long-term extension study evaluating mirikizumab in adults with Crohn’s disease who completed prior AMAM/AMAG studies.
Participants are assigned to maintenance mirikizumab 300 mg subcutaneously every 4 weeks or to an initial IV 900 mg induction followed by 300 mg SC Q4W for 52 weeks, with primary outcomes including endoscopic response (SES-CD) and clinical remission (CDAI <150) at Week 52.
The entry lists inclusion/exclusion criteria tied to completion of the originating studies, safety exclusions (notably active infections and hypersensitivity), contraception requirements for female participants, and multiple U.S. study sites. Planned enrollment is 996 and the record status is Active, Not Recruiting.
This summary is grounded in the trial registry entry; it describes the registered design and endpoints and does not report results or interpret efficacy or safety findings.
This is a trial registry record describing study design, eligibility, interventions, and planned endpoints; it does not contain study results. Mirikizumab is the investigational agent here; any clinical decisions should rely on peer-reviewed results and regulatory guidance when available.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
People with moderate-to-severe Crohn's disease or ulcerative colitis and their clinicians may want to know how long patients stay on guselkumab in real-world care, since persistence reflects tolerability, benefit, and...
The article summarizes recent drug approvals and Phase 3 trial results that could affect which biologic treatments are available and how the Crohn's disease treatment market may change. It also gives epidemiology and...
There are many new drugs and trials underway for Crohn’s disease, which could expand future treatment options. Recent phase 2 and phase 3 starts from major pharma show active investment in IBD research.
