Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NDI-034858 · 1 trial · 1 indication
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...
NDI-034858 is an investigational small molecule being studied for the treatment of active psoriatic arthritis. It is not approved by the FDA and is currently in clinical development. A Phase 2 trial evaluated its efficacy, safety, and tolerability in participants with this condition.
NDI-034858 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's potential in treating psoriatic arthritis.
NDI-034858 is in Phase 2 clinical development. A Phase 2 trial for psoriatic arthritis has been completed. The drug is investigational and has not received FDA approval.
NDI-034858 has one completed Phase 2 trial, NCT05153148, which evaluated its efficacy, safety, and tolerability in 305 participants with active psoriatic arthritis. The trial was randomized, double-blind, and placebo-controlled, and took place in the United States, Czechia, Germany, and Poland.
No, NDI-034858 is not FDA approved. It is an investigational drug currently in clinical development for psoriatic arthritis. Its Phase 2 trial has been completed, but it has not yet received regulatory approval.