You are now leaving the Lilly Medical website
The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.
Click "Continue" to proceed or "Return" to return to Lilly Medical
If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
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
Treat-Through Study Design in VIVID-1
VIVID-1 (NCT03926130) was a phase 3, multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled study that evaluated the efficacy and safety of mirikizumab in patients with moderately to severely active Crohn's disease. It was the first completed phase 3 study in Crohn's disease with a treat-through design, including comparisons with active treatment and placebo over 1 year of treatment.4
Patients were randomized in a 6:3:2 ratio to receive mirikizumab, ustekinumab, or placebo. Total treatment duration was 52 weeks, comprising a 12-week induction period followed by 40 weeks of maintenance.4
The VIVID-1 study evaluated 2 coprimary composite endpoints comparing mirikizumab with placebo:
- the proportion of patients who achieved a clinical response by patient-reported outcome (PRO) at week 12 (at least 30% reduction in stool frequency or abdominal pain score, or both, and neither score worse than baseline) and clinical remission by Crohn's Disease Activity Index (CDAI <150) at week 52, and
- the proportion of patients who achieved a PRO clinical response at week 12 and an endoscopic response at week 52 (at least 50% reduction from baseline in the Simple Endoscopic Score for Crohn's Disease total score).4
Unless specified, all binary endpoints comparing mirikizumab with placebo after week 12 were defined as composite endpoints that included achievement of a week 12 clinical response by PRO because placebo nonresponders switched to mirikizumab after week 12.4
Historically, phase 3 studies in Crohn's disease have adopted a randomized withdrawal design that evaluates outcomes in responders to active induction therapy. In contrast, VIVID-1 implemented a treat-through design with composite endpoints.4
The proportion of mirikizumab-treated patients who achieved clinical remission by CDAI at week 52 in VIVID-1 was
- 45.4% in the treat-through analysis with a composite endpoint (primary analysis set, n=579)
- 54.1% in the treat-through analysis without the week 12 response requirement (primary analysis set, n=579), and
- 64.3% in a post hoc analysis among induction responders only.4
The nearly 20-percentage-point variation (from 45.4% to 64.3%) observed across analytical methods underscores the limitations of directly comparing unadjusted week 52 outcomes among phase 3 trials with different study designs, even before considering variations in endpoint definitions, timepoints, and inclusion criteria.4
Enclosed Prescribing Information
OMVOH® (mirikizumab-mrkz) injection, for intravenous or subcutaneous use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- US 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 September 24, 2026. https://www.fda.gov/media/158001/download
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
- Sands 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
- Ferrante M, D’Haens G, Jairath V, et al; VIVID Study Group. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. Lancet. 2024;404(10470):2423-2436. https://doi.org/10.1016/S0140-6736(24)01762-8
Date of Last Review: September 17, 2026