Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05153148 | A Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Participants With Active Psoriatic Arthritis | PHASE2 | COMPLETED | 305 | — | — | Jan 6, 2022 | Jun 2, 2023 | May 31, 2024 | 56 | United States, Czechia +2 |
ACR20 is composite measure defined as improvement of 20 percent(%) from baseline in both number of tender (68) \& number of swollen (66) joints \& a 20% improvement in at least 3 of following 5 criteria: patient global assessment of psoriatic arthritis (PGA-PsA) \[visual analog scale (VAS) where, 0=very good, no symptoms \& 100=very poor, severe symptoms\], physician global assessment of psoriatic arthritis (PhGA-PsA) \[(VAS) where 0=no disease activity \& 100=maximum disease activity\], patient global assessment of psoriatic arthritis pain (PGAAP) \[(VAS) where 0=no pain \& 100=most severe pain\], disability history questionnaire i.e., Health Assessment Questionnaire-Disability Index \[HAQ-DI\] (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip \& activities, 0=without difficulty to 3=unable to do) \& acute phase reactant like high sensitivity C-reactive protein \[hsCRP\]). Percentages are rounded off to the nearest decimal.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo capsules, orally, QD for 12 weeks. |
| NDI-034858 Low Dose | EXPERIMENTAL | Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks. |
| NDI-034858 Medium Dose | EXPERIMENTAL | Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks. |
| NDI-034858 High Dose | EXPERIMENTAL | Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| NDI-034858 | DRUG | NDI-034858 oral capsule |
| Placebo | OTHER | NDI-034858-matching oral placebo capsule |
Inclusion Criteria: * Participant has PsA on the basis of the Classification Criteria for Psoriatic Arthritis with peripheral symptoms at the screening visit. * Participant has a history of PsA symptoms for ≥ 6 months prior to the screening visit. * Participant has ≥ 3 tender joints and ≥ 3 swollen...