Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Soquelitinib · 3 trials · 11 indications
Time from first study treatment to first occurrence of progression (as assessed by the Independent Review Committee) or death, whichever occurs first
EASI is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head and neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib compared with placebo, including changes in laboratory values, vital signs, and electrocardiograms (ECGs)
| Arm | Type | Description |
|---|---|---|
| Soquelitinib | EXPERIMENTAL | Participants will administer soquelitinib 200 mg orally twice daily for up to 2 years |
| Standard of Care | ACTIVE_COMPARATOR | Participants will receive physician's choice standard of care treatment of either pralatrexate or belinostat for up to 2 years |
| Cohort 1 - Soquelitinib 200 mg once daily | EXPERIMENTAL | Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding. |
| Cohort 2 - Soquelitinib 200 mg twice daily | EXPERIMENTAL | Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding. |
| Cohort 3 - Soquelitinib 400 mg once daily | EXPERIMENTAL | Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding. |
| Placebo | PLACEBO_COMPARATOR | Placebo tablets will be taken orally twice daily for 12 weeks. |
| Soquelitinib Dose Escalation and Dose Expansion | EXPERIMENTAL | In Dose Escalation, participants will receive soquelitinib tablets orally at one of three dose levels (100 mg twice daily, 200 mg once daily, 200 mg twice daily) for 28 days. In Dose Expansion, participants will receive soquelitinib tablets orally at a dose selected from the dose escalation part of the study, for 56 days |
| Name | Type | Description |
|---|---|---|
| Soquelitinib | DRUG | Soquelitinib 200 mg tablets will be taken by mouth two times a day |
| Belinostat | DRUG | Belinostat (1000 mg/m2) will be administered by intravenous infusion once daily on Days 1 through 5 of each 21-day cycle |
| Pralatrexate | DRUG | Pralatrexate (30 mg/m2) will be administered intravenously over 3 to 5 minutes once weekly for 6 weeks in each 7-week cycle |
| Placebo | DRUG | Soquelitinib matching placebo tablets |
Inclusion Criteria: 1. Adult participants ≥18 years of age on the day of signing the informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. 3. Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymph...