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Introduction <p>Mirikizumab, an anti-interleukin-23 p19 monoclonal antibody, is approved for treating adults with moderately to severely active ulcerative colitis and Crohn’s disease. For ulcerative colitis maintenance therapy, mirikizumab is administered via two 1-ml subcutaneous (SC) injections. Volume and number of SC administrations can impact injection site reactions and local pain, as well as treatment compliance. We assessed the pharmacokinetic (PK) and safety comparability of an investigational one 2-ml SC injection compared with the commercially available two 1-ml SC injections.</p> Methods <p>In this phase&#xa0;1 study, USA-based healthy adults were stratified by weight and randomized (1:1) to receive citrate-free 200&#xa0;mg SC mirikizumab as either two 1-ml injections (each 100&#xa0;mg) or one 2-ml (200&#xa0;mg) injection, delivered by an autoinjector. Participants in each arm were subrandomized by injection site location (arm, abdomen, or thigh). Blood sampling and safety assessments were conducted up to 10&#xa0;weeks post dose. The primary endpoint was PK, and the secondary endpoint was safety.</p> Results <p>A total of 244 participants received one injection and 240 received two injections (mean age 42.5&#xa0;years; 51.0% female). Baseline characteristics were similar in both groups. Primary PK parameters fell within the bioequivalence range (geometric least-squares mean [GLSM] ratio 0.800–1.250). Observed GLSMs were consistent across injection site locations. Treatment-emergent adverse events were reported in 48 participants with one injection (19.7%) and 55 with two injections (22.9%); most were mild (62/74 events with one injection [83.8%] and 85/100 with two injections [85.0%]). No serious adverse events were reported in either group.</p> Conclusion <p>Mirikizumab 200&#xa0;mg administered as one 2-ml SC injection was bioequivalent to two 1-ml injections, and most treatment-emergent adverse events were mild in both groups. In clinical practice, reducing the number of injections may improve treatment adherence.</p> Trial registration <p>ClinicalTrials.gov identifier NCT06475729.</p>

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One Subcutaneous 2-ml Injection of Mirikizumab is Bioequivalent to Two 1-ml Subcutaneous Injections in Healthy Participants

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月28日

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  • Yuki Otani,
  • Christopher D. Payne,
  • Edward V. Loftus Jr.,
  • Geert D’Haens,
  • Shomron Ben Horin,
  • Abhishek Upadhya K,
  • Kristin Todd,
  • Paola Pellanda,
  • Galen Shi,
  • Xin Zhang

摘要

Introduction

Mirikizumab, an anti-interleukin-23 p19 monoclonal antibody, is approved for treating adults with moderately to severely active ulcerative colitis and Crohn’s disease. For ulcerative colitis maintenance therapy, mirikizumab is administered via two 1-ml subcutaneous (SC) injections. Volume and number of SC administrations can impact injection site reactions and local pain, as well as treatment compliance. We assessed the pharmacokinetic (PK) and safety comparability of an investigational one 2-ml SC injection compared with the commercially available two 1-ml SC injections.

Methods

In this phase 1 study, USA-based healthy adults were stratified by weight and randomized (1:1) to receive citrate-free 200 mg SC mirikizumab as either two 1-ml injections (each 100 mg) or one 2-ml (200 mg) injection, delivered by an autoinjector. Participants in each arm were subrandomized by injection site location (arm, abdomen, or thigh). Blood sampling and safety assessments were conducted up to 10 weeks post dose. The primary endpoint was PK, and the secondary endpoint was safety.

Results

A total of 244 participants received one injection and 240 received two injections (mean age 42.5 years; 51.0% female). Baseline characteristics were similar in both groups. Primary PK parameters fell within the bioequivalence range (geometric least-squares mean [GLSM] ratio 0.800–1.250). Observed GLSMs were consistent across injection site locations. Treatment-emergent adverse events were reported in 48 participants with one injection (19.7%) and 55 with two injections (22.9%); most were mild (62/74 events with one injection [83.8%] and 85/100 with two injections [85.0%]). No serious adverse events were reported in either group.

Conclusion

Mirikizumab 200 mg administered as one 2-ml SC injection was bioequivalent to two 1-ml injections, and most treatment-emergent adverse events were mild in both groups. In clinical practice, reducing the number of injections may improve treatment adherence.

Trial registration

ClinicalTrials.gov identifier NCT06475729.