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IL-6 inhibition with vamikibart in patients with uveitic macular edema: Study Design of the Phase 3 MEERKAT and SANDCAT trials
Presenter:
Quan Dong Nguyen, MD, MSc
Authors:
Quan Dong Nguyen, MD, MSc, Laura Steeples, MBChB (Hons), FRCOphth, Markus Elze, PhD, Lachlan Macgregor, MBBS, MMedSc, MBios, David Silverman, MSc, MBChB, MRCOphth, Zdenka Haskova, MD, PhD, Eric Suhler, MD, MPH
1. Quan Dong Nguyen, MD, MSc; Byers Eye Institute, Stanford University, Palo Alto, CA, USA.
2. Laura Steeples, MBChB (Hons), FRCOphth; Roche Products Ltd., Welwyn Garden City, UK.
2. Markus Elze, PhD; F. Hoffmann-La Roche AG, Basel, Basel-Stadt, Switzerland.
3. Lachlan Macgregor, MBBS, MMedSc, MBios; F. Hoffmann-La Roche AG, Basel, Basel-Stadt, Switzerland.
4. David Silverman, MSc, MBChB, MRCOphth; Roche Products Ltd., Welwyn Garden City, UK.
5. Zdenka Haskova, MD, PhD; Genentech, Inc., South San Francisco, CA, USA.
6. Eric Suhler, MD, MPH; Casey Eye Institute, Oregon Health & Science University, Portland, OR, USA.
Affiliation:
Purpose
Uveitic macular edema (UME) is the most common vision-threatening complication in non-infectious uveitis (NIU). Inflammation plays a key role in UME pathophysiology and is characterized by increased intraocular level of proinflammatory cytokines, including interleukin-6 (IL-6). Corticosteroids are the mainstay of treatment but lead to well-recognized adverse events. There is a need for effective, non-corticosteroid therapies for UME. Vamikibart (RG6179) is a recombinant, humanized, monoclonal antibody, engineered for intravitreal delivery, that binds to and inhibits IL-6 activity, and was trialed in patients with UME in the Phase 1 DOVETAIL study. Efficacy and safety results from DOVETAIL supported further evaluation. We report the study designs of MEERKAT and SANDCAT, two ongoing Phase 3 trials of vamikibart in UME.
Methods
Two identical, global, randomized, double-masked, sham-comparator controlled Phase 3 trials, MEERKAT (study GR44277, NCT05642312) and SANDCAT (study GR44278, NCT05642325), are investigating the efficacy, safety, PK and PD of intravitreal vamikibart in patients with UME (N=225 per study, across 26 countries). Key eligibility criteria include diagnosis of macular edema, defined by macular thickening, associated with NIU, and BCVA scores of 73-19 ETDRS letters. Patients with active or inactive, acute or chronic NIU of any etiology or anatomical type are eligible to enroll. Patients are randomized into 3 arms: vamikibart 0.25mg, vamikibart 1mg and sham. Study treatment is administered 4 times every 4 weeks through Week 12, followed by as needed dosing from Week 20 to 48. Predefined rescue criteria allow standard-of-care treatment for patients with worsening BCVA, UME, or inflammation.
Results
Primary outcome measure is proportion of patients with ≥15 letter BCVA improvement from baseline at Week 16. Secondary endpoints include changes in BCVA and central subfield thickness, rescue medications requirements, adverse events, and concentrations of IL-6 and vamikibart in aqueous humor and serum.
Conclusions
The ongoing global Phase 3 MEERKAT and SANDCAT program will evaluate vamikibart and its potential to address the unmet need for effective non-corticosteroid treatments in UME.