Eli Lilly and Company (Lilly) has worked with numerous psoriasis experts, including International Psoriasis Council advisors and industry experts, to develop the sPGA-G™ scale for use as a clinical outcome measure. Please see
Merola JF, Bleakman AP, Gottlieb AB, Menter A, Naegeli AN, Bissonnette R, Guenther L, Sullivan J, Meeuwis K, See K, Duffin KC. The Static Physician’s Global Assessment of Genitalia: A Clinical Outcome Measure for the Severity of Genital Psoriasis. J Drugs
As part of the effort, Lilly has made the sPGA-G™ scale available for use and has made the investigator training video available to access and review by other companies, academic groups and clinicians, free of charge.
Any use of the scale is subject to the terms of the CC BY-ND 4.0 license which license terms must be reviewed and agreed to prior to any download or use.
The sPGA-G™ training video is available for viewing at Trifecta. Please note that “view only” access means that slide content cannot be downloaded or copied in any manner including by screenshot or by photographs of screen images. All rights in the training materials are reserved by Lilly.
Trifecta can add slides preceding the training video with information pertaining to the sponsor and their study. To access the training video and certification please contact Trifecta directly Eric Zudak.
To ensure harmonization in the assessment of psoriasis patients, and consistent with the terms of the CC BY-ND 4.0 license it is subject to, no modifications can be made to the sPGA-G™ without Lilly’s prior written consent. This royalty-free non-exclusive license will allow all to use the sPGA-G™ scale in clinical studies, as long as they give credit to Lilly as stated at the bottom of the sPGA-G™scale.
Any existing translations of the sPGA-G™ scale will also be made available subject to the terms of the CC BY-ND 4.0 license. In the event that a new translation is needed, Lilly’s permission will be required. We ask that the requestor create the desired translation and provide a copy of it and a certification of linguistic validation of the translated version to Lilly and IPC for review and approval. This will ensure consistency in the use of the scale across geographies.
Please note that drafts as well as the final version of the sPGA-G™ were shared with the FDA during the development of this scale.
The FDA indicated that the final sPGA-G™ scale was adequate to assess the efficacy of one of Lilly’s products being developed for treatment of psoriasis. If your company chooses to use the sPGA-G™ in your clinical programs, you should contact Lilly if the FDA or another health authority requests changes to the scale. Any modifications to the scale will need to be carefully considered in light of the goal of this collaborative harmonization effort.
To obtain permission for any modification, including translations, please contact Lilly.