A Phase 3 Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial With Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients With Primary Sjögren's Disease
A Phase 3 Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial With Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients With Primary Sjögren's Disease
The main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD). The study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. The maximum study duration for participants in both study parts is approximately 105 weeks.
Inclusion Criteria:
Exclusion Criteria:
Chicago, Illinois 60640, United States
CABA, Buenos Aires C1427CCL, Argentina
Luoyang, Henan 471003, China
Wuhan, Hubei 430030, China
Bogotá, 110221, Colombia
Hamburg, Free and Hanseatic City of Hamburg 20095, Germany
Brescia, 25123, Italy
Nishinomiya-shi, Hyōgo 663-8501, Japan
Kahoku-gun, Ishikawa-ken 920-0293, Japan
Kita-gun, Kagawa-ken 761-0793, Japan
Sasebo-shi, Nagasaki 857-1195, Japan
Izumo-shi, Shimane 693-8501, Japan
Itabashi-ku, Tokyo-To 173-8610, Japan
Meguro-ku, Tokyo-To 152-8902, Japan
Shinjuku-ku, Tokyo-To 160-8582, Japan
El Shouf, 678002, Lebanon
San Luis Potosí City, 78200, Mexico
San Luis Potosí City, 78213, Mexico
Ortigas, 1605, Philippines
Ponte de Lima, 4990-041, Portugal