Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NDI-034858 study drug · 1 trial · 1 indication
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 75 response is a binary measure defined as at least a 75% improvement in PASI score at Week 12, relative to baseline PASI score.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo matched to NDI-034858 oral capsules, once daily (QD) for up to 12 weeks. |
| NDI-034858 2 milligrams (mg) | EXPERIMENTAL | Participants received 2 mg of NDI-034858 oral capsules, QD for up to 12 weeks. |
| NDI-034858 5 mg | EXPERIMENTAL | Participants received 5 mg of NDI-034858 oral capsules, QD for up to 12 weeks. |
| NDI-034858 15 mg | EXPERIMENTAL | Participants received 15 mg of NDI-034858 oral capsules, QD for up to 12 weeks. |
| NDI-034858 30 mg | EXPERIMENTAL | Participants received 30 mg (2\*15 mg) of NDI-034858 oral capsules, QD for up to 12 weeks. |
| Name | Type | Description |
|---|---|---|
| NDI-034858 study drug | DRUG | NDI-034858 2 mg oral capsules. |
| Placebo | OTHER | Placebo matched to NDI-034858 oral capsules. |
Inclusion Criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria, either at the screening and Day 1 visits or only at one of the specified visits (screening or Day 1) as noted in the criterion: 1. Male or female participant aged 18 to ...