TED01RV: A multicenter, double-masked, placebo-controlled, efficacy and safety study of rv 001, an insulin-like growth factor-1 receptor (igf-1r) antagonist antibody (fully human), administered every 3 weeks (q3w) by intravenous (iv) infusion in patients suffering from active thyroid eye disease (ted)
Laufzeit: 01.01.2013 - 31.12.2017
Kurzfassung
RV 001 was originally developed under the code name RO 4858696 by F. Hoffman-La Roche Ltd., for the treatment of patients with advanced solid tumors, including sarcoma. The compound is no longer being developed in this indication based on insufficient clinical efficacy and portfolio prioritization. Development of RV 001 was not terminated due to any observed safety issues.
River Vision has licensed the compound (now identified as RV 001) and will pursue its development in ophthalmic...RV 001 was originally developed under the code name RO 4858696 by F. Hoffman-La Roche Ltd., for the treatment of patients with advanced solid tumors, including sarcoma. The compound is no longer being developed in this indication based on insufficient clinical efficacy and portfolio prioritization. Development of RV 001 was not terminated due to any observed safety issues.
River Vision has licensed the compound (now identified as RV 001) and will pursue its development in ophthalmic indications including thyroid eye disease (TED; also known as Graves' Ophthalmopathy or Orbitopathy [GO] and thyroid-associated ophthalmopathy [TAO]) and diabetic macular edema (DME).
This version of the Investigational Brochure (IB) summarizes the non-clinical and clinical experience with RV 001, in particular the clinical development in the oncology indications, and provides a rationale for the development of the compound in the ophthalmic indications.
Data cut-off dates for the safety summaries pertaining to the Roche oncology trials are indicated in each relevant section and relate to pooled data from a 12 June 2009 data cut-off plus additional clinical safety data collected to a 12 July 2010 data cut-off.
Available blinded adverse event data from the ongoing study in thyroid eye disease (TED01RV) are provided in Appendix 4. Available adverse event data from the ongoing the open-label study in diabetic macular edema patients (DME01RV) are provided in Appendix 5. The clinical data cut-off date for both studies was 08 December 2015.
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