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Omvoh ® (mirikizumab-mrkz) injection
300 mg/15 mL, 100 mg/mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Why does the Omvoh® (mirikizumab-mrkz) VIVID-1 study use a treat-through study design?
The VIVID-1 study used a treat-through study design for a more comprehensive understanding of week 52 outcomes, better reflection of clinical practice, ease of interpretation of study results, and identification of delayed responder subgroups.
Crohn's Disease Clinical Development Study Designs
The US Food and Drug Administration recommends that sponsors developing drug therapies for the treatment of Crohn's disease use a randomized, double-blind, placebo-controlled trial designed to demonstrate that clinical benefits achieved initially are maintained with chronic administration of study drug. This can be achieved with either induction therapy followed by randomized withdrawal maintenance or a treat-through study design.1
Benefits of Treat-Through Study Designs
More Comprehensive Understanding of Week 52 Efficacy and Safety
A treat-through study design provides clinicians with a more comprehensive understanding of mirikizumab's efficacy and safety at week 52 in the intended population. Patients with Crohn's disease often experience a delay in achieving endoscopic and histologic improvement. By using a treat-through study design, patients who complete the induction phase have the opportunity to participate in the maintenance phase of the study regardless of their response at week 12.2
Better Reflection of Real Clinical Practice
A treat-through study design better replicates real clinical practice where the prescriber can decide if treatment to the patient may be beneficial beyond induction response criteria.2
Ease of Interpretation
Because the patient populations in a treat-through study remain relatively constant other than small fluctuations due to study discontinuations, the results are easier to interpret compared with results of integrated induction and maintenance studies which must account for rerandomization.3
Identification of Delayed Responder Subgroups
A treat-through study design may be beneficial if a delayed response to therapy is anticipated as this may allow for the identification of subgroups of patients who may have a delayed response to treatment because patients are assessed beyond the induction phase while still receiving the randomized controlled treatment. This approach may also more accurately reflect clinical practice when prescribers and patients persist with treatment if some benefit is initially observed and extended induction may be justified.3
Enclosed Prescribing Information
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Crohn’s disease: developing drugs for treatment. Guidance for industry. April 2022. Accessed October 12, 2023. https://www.fda.gov/media/158001/download
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Sands BE, Cheifetz AS, Nduaka CI, et al. The impact of raising the bar for clinical trials in ulcerative colitis. J Crohns Colitis. 2019;13(9):1217-1226. https://dx.doi.org/10.1093/ecco-jcc/jjz038
Date of Last Review: October 12, 2023