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Also known as GLPG3667 oral suspension, GLPG3667 capsule, [14C]-GLPG3667 solution for infusion, GLPG3667 for infusion, Cadefrecitinib
GLPG3667 · 3 trials · 3 indications
The TIS is a score derived from the evaluation of the results from 6 core set measurements (CSMs) of myositis disease activity: Physician's Global Disease Activity Assessment; Patient's Global Disease Activity Assessment; Muscle Manual Test-8 (MMT-8); Health Assessment Questionnaire-Disability Index (HAQ-DI); Enzymes (aldolase, creatine kinase (CK), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and lactate dehydrogenase (LDH); and Extra-muscular disease activity. The TIS is a scale from 0 to 100 that allows for the discrimination between minimal, moderate and major responders depending on their improvement in the combined 6 CSM.
To evaluate the safety and tolerability of GLPG3667 compared to placebo in subjects with moderate to severe plaque psoriasis.
To evaluate signs of clinical efficacy of GLPG3667 compared to placebo in subjects with moderate to severe plaque psoriasis.
| Arm | Type | Description |
|---|---|---|
| GLPG3667 - Treatment A | EXPERIMENTAL | Participant will receive a dose A of GLPG3667 capsules orally once daily (q.d.) for 48 weeks. |
| GLPG3667 - Treatment B | EXPERIMENTAL | Participant will receive a dose B of GLPG3667 capsules orally (q.d.) for 48 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participant will receive placebo matched to GLPG3667 capsules orally q.d for 48 weeks. |
| GLPG3667 During DB + During OLE | EXPERIMENTAL | Participants will receive GLPG3667 dose A orally once daily for 24 weeks in the double-blind (DB) treatment period. Eligible participants will roll-over to an open-label extension (OLE) period to receive the same dose for another 24 weeks. |
| Placebo During DB + GLPG3667 During OLE | PLACEBO_COMPARATOR | Participants will receive placebo matching to GLPG3667 orally once daily for 24 weeks in the DB treatment period. Eligible participants will roll-over to an OLE period to receive GLPG3667 dose A orally once daily for another 24 weeks. |
| GLPG3667 Dose A | EXPERIMENTAL | Daily doses of GLPG3667 for 4 weeks. |
| GLPG3667 Dose B | EXPERIMENTAL | Daily doses of GLPG3667 for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| GLPG3667 | DRUG | Capsule |
| Placebo | DRUG | Capsule |
Key Inclusion Criteria: 1. Participant with documented diagnosis of SLE as defined by the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria with a disease diagnosed ≥24 weeks before the screening visit. 2. Participant has a total Systemic...
GLPG3667 is an investigational oral small molecule developed by Lakefront Biotherapeutics (ticker LKFT) for immunology indications. It is being studied in dermatomyositis, plaque psoriasis, and systemic lupus erythematosus. It remains in clinical development and is not approved for any use.
GLPG3667 is being studied for three immune-mediated conditions: systemic lupus erythematosus, dermatomyositis, and moderate to severe plaque psoriasis. Clinical testing has covered all three indications, with the largest study enrolling adults with active systemic lupus erythematosus.
Lakefront Biotherapeutics, which trades under the ticker LKFT, is the developer of GLPG3667. The company has sponsored Phase 1 and Phase 2 studies of the oral small molecule across dermatomyositis, plaque psoriasis, and systemic lupus erythematosus.
GLPG3667 is in Phase 2 development. A Phase 2 study in systemic lupus erythematosus and a Phase 2 study in dermatomyositis have both been completed, along with a Phase 1 study in plaque psoriasis. It is an investigational drug and has not been approved by the FDA.
Three completed trials have evaluated GLPG3667: NCT05856448, a Phase 2 placebo-controlled study in 186 adults with active systemic lupus erythematosus; NCT05695950, a Phase 2 study in 40 adults with dermatomyositis; and NCT04594928, a Phase 1 study in 30 adults with moderate to severe plaque psoriasis.
Yes. GLPG3667 oral suspension, GLPG3667 capsule, [14C]-GLPG3667 solution for infusion, and GLPG3667 for infusion are all names for the same investigational compound. They describe different formulations and administration forms used in its clinical studies, not separate drugs.