Center for Innovative Therapy (CIT)
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If you are interested in finding out more information about a particular study, please contact the study personnel, Ms. Linda Mendoza at (858) 246-2389.
Interventional | Abbvie | SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | Kenneth Kalunian, M.D. |
Study Type | Sponsor | Details | Principal Investigator |
Interventional | Artiva | A Phase 1 Study to Evaluate the Efficacy and Safety Of AB-101, an Allogeneic Cord Blood Derived NK-Cell Therapy in Combination With B-Cell Depleting monoclonal, in Patients Who Failed Treatment for Refractory Systemic Lupus Erythematosus | Bethany Karl, D.O. |
Interventional | Biogen | TOPAZ-1: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | Arthur Kavanaugh, M.D. |
Interventional | BMS | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants with Active Systemic Lupus Erythematosus | Chelsey Smith, M.D. |
Interventional | BMS | POETYK SLE-2: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus | Chelsey Smith, M.D. |
Interventional | CuGENE | A Phase Ib, Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 following Multiple Dose Administrations in Participants with Mild-to-Moderate Systemic Lupus Erythematosus | Kenneth Kalunian, M.D. |
Interventional | Feinstein | Pilot Trial of Belimumab in Early Lupus | Kenneth Kalunian, M.D. |
Interventional | Galapagos | GALARISSO: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GLPG3667 in Adult Subjects with Active Systemic Lupus Erythematosus | Kenneth Kalunian, M.D. |
Interventional | Idorsia | OPUZ-2: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects with Moderate-to-Severe Systemic Lupus Erythematosus on Top of Background Therapy | Kenneth Kalunian, M.D. |
Interventional | Novartis | SIRIUS-SLE 1: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Two Regimens of Ianalumab on Top of Standard-of-Care Therapy in Patients with Systemic Lupus Erythematosus | Chelsey Smith, M.D. |
Interventional | Gilead | COSMIC: A Randomized, Blinded, Placebo-Controlled, Phase 2a, Proof-of-Concept Study to Evaluate Efficacy, Safety, and Tolerability of GS-5718 in Participants With Cutaneous Lupus Erythematosus | Arthur Kavanaugh, M.D. |
Study Type | Sponsor | Details | Principal Investigator |
Interventional | Astra Zeneca | LAVENDER: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/or Subacute Cutaneous Lupus Erythematosus who are Refractory and/or Intolerant to Antimalarial Therapy | Arthur Kavanaugh, M.D. |
Interventional | Biogen | AMETHYST: A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy | Arthur Kavanaugh, M.D. |
Study Type | Sponsor | Details | Principal Investigator |
Interventional | Atyr | EFZO-CONNECT: Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of Efzofitimod in Patients with Systematic Sclerosis Related Interstitial Lung Disease | Arthur Kavanaugh, M.D. |
Study Type | Sponsor | Details | Principal Investigator |
Interventional | Artiva | A Phase 1 Study to Evaluate the Efficacy and Safety Of AB-101, an Allogeneic Cord Blood Derived NK-Cell Therapy in Combination With B-Cell Depleting monoclonal, in Patients Who Failed Treatment for Class III or IV Lupus Nephritis | Bethany Karl, D.O. |
Interventional | HI-Bio | An Open Label Phase 1b Study of Felzartamab in Lupus Nephritis | Kenneth Kalunian, M.D. |
Interventional | Horizon | OASIZ-303: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren’s Syndrome With Moderate-to-Severe Symptom State | Monica Guma, M.D., Ph.D. |
Study Type | Sponsor | Details | Principal Investigator |
Interventional | Horizon | OASIZ-301: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren’s Syndrome With Moderate-to-severe Systemic Disease Activity | Monica Guma, M.D., Ph.D. |