Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ME3183 · 1 trial · 1 indication
The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI score. The final PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Missing PASI at Week 16 are imputed as non-responders via NRI.
| Arm | Type | Description |
|---|---|---|
| ME3183 Dose 1, BID | EXPERIMENTAL | Specified dose of ME3183 capsule for 16 weeks |
| ME3183 Dose 2, QD | EXPERIMENTAL | Specified dose of ME3183 capsule for 16 weeks |
| ME3183 Dose 3, BID | EXPERIMENTAL | Specified dose of ME3183 capsule for 16 weeks |
| ME3183 Dose 4, QD | EXPERIMENTAL | Specified dose of ME3183 capsule for 16 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo capsule of ME3183 for 16 weeks |
| Name | Type | Description |
|---|---|---|
| ME3183 | DRUG | ME3183 capsule |
| Placebo | DRUG | Placebo capsule |
Inclusion Criteria: * Male and female, ages 18 to 75 years * Participant with stable moderate to severe chronic plaque psoriasis of at least 24 weeks duration. Exclusion Criteria: * Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major unco...