Trial reportAdvances in therapy2026
One Subcutaneous 2-ml Injection of Mirikizumab is Bioequivalent to Two 1-ml Subcutaneous Injections in Healthy Participants.
Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06475729 (A Bioequivalence Study of Subcutaneous Injections of Citrate-Free Mirikizumab Solution Using a 1-mL Autoinjector and an Investigational 2-mL Autoinjector in Healthy Participants), which is not on this map. Not yet cited in PubMed.
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A Bioequivalence Study of Subcutaneous Injections of Citrate-Free Mirikizumab Solution Using a 1-mL Autoinjector and an Investigational 2-mL Autoinjector in Healthy Participants
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionMirikizumab, 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.
methodsIn 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.
resultsA 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.
conclusionMirikizumab 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 registrationClinicalTrials.gov identifier NCT06475729.
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