ECEESPE2025 Poster Presentations Thyroid (141 abstracts)
THRIVE-2 phase 3 trial of Veligrotug (VRDN-001) in chronic thyroid eye disease (TED): efficacy and safety at 15 weeks
Patrice Rodien 1 , Michael Schittkowski 2 , Onur Konuk 3 , Anja Eckstein 4 , Adrienne Csutak 5 , Edwina Eade 6 , Jimmy Uddin 7 , Vickie Lee 8 , Marco Sales Sanz 9 , Will Conroy 10 , Abhijit Narvekar 10 , Thomas Ciulla 10 & Antonio Manuel Garrido Hermosilla 11
1Centre Hospitalier Universitaire d’Angers – Hématologie, Angers, France; 2Universitätsmedizin Göttingen, Göttingen, Germany; 3Gazi University Medical School, Department of Ophthalmology, Ankara, Türkiye; 4Universitätsmedizin Essen, School of Vision, Essen, Germany; 5Optimum Vision Center, Budapest, Hungary; 6North Shore Private Hospital, New South Wales, Australia; 7Moorsfields Eye Hospital, London, UK; 8Imperial College Healthcare NHS Trust – Western eye Hospital, London, UK; 9Hospital Universitario Ramón y Cajal, Madrid, Spain; 10Viridian Therapeutics, Inc., Waltham, USA; 11Hospital Universitario Virgen Macarena, Universidad de Sevilla, Seville, Spain
JOINT515
Purpose: TED remains a condition with significant unmet needs, particularly in the chronic phase, where treatment options are limited. IGF-1R antagonism has emerged as a key therapeutic approach, addressing inflammation and proptosis. Veligrotug (veli), a full antagonist humanized monoclonal antibody targeting IGF-1R, previously demonstrated positive results in the ongoing phase 3 THRIVE trial for active TED. Here, we present efficacy and safety data from the ongoing phase 3 THRIVE-2 trial (NCT06021054) of veli in chronic TED at the primary timepoint of 15 weeks.
Methods: Adults with moderate-to-severe chronic TED (onset >15 months, proptosis ≧3 mm, with any clinical activity score [CAS]) were randomized (2:1) to 5 IV infusions 3 weeks apart of either 10 mg/kg veli or placebo. The following were assessed through 15 weeks: proptosis responder rate (PRR), defined as ≧2-mm reduction vs baseline by Hertel exophthalmometry; overall responder rate (ORR; PRR and no worsening in CAS); PRR by MRI/CT; mean change from baseline in proptosis; improvement and complete resolution on the Gorman subjective diplopia scale; and treatment-emergent adverse events (TEAEs).
Results: 188 patients were randomized to veli (n=125) or placebo (n=63) and included in the intent-to-treat population. Baseline values for veli vs placebo were balanced including mean proptosis, 24.3 mm vs 23.8 mm; presence of diplopia, 52% vs 59%; and CAS ≧3, 57% vs 52%. 15-week results for veli vs placebo were as follows: Hertel PRR, 56% vs 8% (P<0.0001), with a mean reduction of 2.34 mm vs 0.46 mm (P<0.0001); MRI/CT PRR, 48% vs 3% (P<0.0001); ORR, 56% vs 7% (P<0.0001). In patients reporting diplopia on the Gorman subjective diplopia scale at baseline, 56% vs 25% (P=0.0006) reported improvement and 32% vs 14% (P=0.0152) reported complete resolution. Achievement of CAS 0/1 in patients with CAS ≧3 at baseline was nominally significant (54% vs 24%, P=0.0060). Most TEAEs were mild, with most common being muscle spasms (36% vs 6%) and menstrual disorders (33% vs 10% for menstruating women). Hearing impairment was 13% vs 3%. Serious TEAEs were 2% vs 3% (1 related to treatment in each group).
Conclusions: THRIVE-2, which assessed 5 IV infusions of veli vs placebo, is the first RCT in chronic TED to show statistically significant improvement not only in proptosis, but also in diplopia, with a generally well-tolerated safety profile. Results suggest the promising potential of veli in chronic TED. Follow-up through 52 weeks is ongoing.
Volume 110
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Endocrine Abstracts
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