Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as NDI-034858, TAK-279
NDI-034858 study drug · 2 trials · 2 indications
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.
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 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. |
| 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 | DRUG | NDI-034858 oral capsule |
| Placebo | OTHER | NDI-034858-matching oral placebo capsule |
| NDI-034858 study drug | DRUG | NDI-034858 2 mg oral capsules. |
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 being developed for the treatment of moderate to severe plaque psoriasis, a chronic inflammatory skin condition. It is an investigational small molecule under development by Takeda Pharmaceutical Company Limited. The clinical program has focused on adults with moderate to severe forms of the disease.
NDI-034858 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is advancing the small molecule for moderate to severe plaque psoriasis in dermatology.
NDI-034858 is in the NDA/BLA stage of development for moderate to severe plaque psoriasis. It is an investigational small molecule and has not been approved by the FDA. The program has completed a Phase 2 clinical trial.
NDI-034858 has been studied in one completed Phase 2 trial, NCT04999839, titled Study of NDI-034858 in Participants With Moderate to Severe Plaque Psoriasis. The randomized, double-blind, placebo-controlled trial enrolled 259 adults aged 18 and older in the United States and Canada.
NDI-034858 is not FDA approved. It is an investigational small molecule in the NDA/BLA stage of development for moderate to severe plaque psoriasis. The only listed clinical trial, NCT04999839, was a completed Phase 2 study.