Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GLPG3667 oral suspension, GLPG3667 capsule, [14C]-GLPG3667 solution for infusion, GLPG3667 for infusion
GLPG3667 · 8 trials · 4 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 determine the effect of itraconazole on the pharmacokinetics (PK) of GLPG3667
To determine the effect of itraconazole on the PK of GLPG3667
To evaluate the safety and tolerability of single and multiple oral doses of GLPG3667, in adult, healthy, male subjects compared with placebo
To determine the effect of GLPG3667 on the pharmacokinetics (PK) of MDZ.
To determine the effect of GLPG3667 on the PK of MDZ.
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. |
| Period 1 - Absolute Bioavailability | EXPERIMENTAL | - |
| Period 2 - Mass Balance | EXPERIMENTAL | - |
| GLPG3667 + itraconazole | EXPERIMENTAL | - |
| GLPG3667 SD | EXPERIMENTAL | Participants will receive a single dose of GLPG3667 |
| Placebo SD | PLACEBO_COMPARATOR | Participants will receive a single dose of matching placebo |
| GLPG3667 MD | EXPERIMENTAL | Participants will receive repeated doses of GLPG3667 for 13 days. |
| Placebo MD | PLACEBO_COMPARATOR | Participants will receive repeated doses of matching placebo for 13 days. |
| GLPG3667 + Midazolam | EXPERIMENTAL | - |
| GLPG3667 Dose A | EXPERIMENTAL | Daily doses of GLPG3667 for 4 weeks. |
| GLPG3667 Dose B | EXPERIMENTAL | Daily doses of GLPG3667 for 4 weeks. |
| GLPG3667 SAD | EXPERIMENTAL | Single doses of GLPG3667 at up to 6 dose levels in ascending order |
| Placebo SAD | PLACEBO_COMPARATOR | Single doses of placebo |
| GLPG3667 MAD | EXPERIMENTAL | Multiple doses of GLPG3667 at up to 3 dose levels in ascending order, daily for 13 days |
| Placebo MAD | PLACEBO_COMPARATOR | Multiple doses of placebo |
| GLPG3667 FE fasted | EXPERIMENTAL | Single dose of GLPG3667 in fasted state |
| GLPG3667 FE fed | EXPERIMENTAL | Single dose of GLPG3667 in fed state |
| GLPG3667 oral suspension rBA-FE fed | EXPERIMENTAL | Single dose of GLPG3667 oral suspension in fed state |
| GLPG3667 capsules rBA-FE fasted | EXPERIMENTAL | Single dose of GLPG3667 capsules in fasted state |
| GLPG3667 capsules rBA-FE fed | EXPERIMENTAL | Single dose of GLPG3667 capsules in fed state |
| Name | Type | Description |
|---|---|---|
| GLPG3667 | DRUG | Capsule |
| Placebo | DRUG | Capsule |
| GLPG3667 capsule | DRUG | On Day 1, participants will receive a single oral dose of GLPG3667 |
| [14C]-GLPG3667 solution for infusion | DRUG | On Day 1, participants will receive a single microtracer microdose of \[14C\]-GLPG3667 as an intravenous infusion |
| [14C]-GLPG3667 capsule | DRUG | On Day 1, participants will receive a single oral dose of \[14C\]-GLPG3667 |
| Itraconazole | DRUG | On days 5 to 11, participants will receive itraconazole once daily |
| Midazolam | DRUG | On Day 1 and Day 7 as liquid formulation, orally in fed state. |
| GLPG3667 oral suspension | DRUG | GLPG3667 oral suspension |
| Placebos | DRUG | Placebo oral suspension |
| GLPG3667 capsules | DRUG | GLPG3667 capsules |
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...