Study of Ixekizumab in Healthy Participants

Phase 1 Terminated 70 enrolled Eli Lilly and Company

RandomizedCrossoverSingle-blindBasic science

Summary

The purpose of this study is to compare the tolerability of injections of each of 3 formulations of ixekizumab using a prefilled syringe. Information about any side effects (including injection site reactions \[ISRs\]) will be collected.

Timeline

Start: 2019-01-29
Primary completion: 2019-07-18
Completion: 2019-07-18

Outcome

Met primary endpoint

Stopped: “At the protocol-specified interim analysis, the sponsor decided to stop the trial.”

paper RESULTS: Primary endpoint was achieved in both studies. PMID 35449322 ↗

paper In study A, least-squares mean (LSM) difference of VAS scores immediately post injection between commercial (n = 61) and CF formulation (n = 63) was - 21.7 (p < 0.0001), indicating a lower degree of pain associated with CF formulation. PMID 35449322 ↗

Publications

Chabra S, Gill BJ, Gallo G, Zhu D, Pitou C, Payne CD, Accioly A, Puig L. Ixekizumab Citrate-Free Formulation: Results from Two Clinical Trials. Adv Ther. 2022 Jun;39(6):2862-2872. doi: 10.1007/s12325-022-02126-0. Epub 2022 Apr 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ixekizumab	Monoclonal antibody	80 mg	Subcutaneous

Indications

No indication recorded.