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...
Soquelitinib is an investigational small molecule being studied for Peripheral T-Cell Lymphoma, Not Otherwise Specified and Atopic Dermatitis. It is in Phase 2 clinical development for Atopic Dermatitis and is also being evaluated in a Phase 3 trial for certain types of relapsed or refractory peripheral T-cell lymphoma.
Soquelitinib is a kinase inhibitor, as indicated by its -tinib suffix. It is being studied for its effects in immune-mediated and oncologic conditions, including Atopic Dermatitis and Peripheral T-Cell Lymphoma. The specific molecular target is not disclosed in available information.
Soquelitinib is being developed by Corvus Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker CRVS. The company is conducting clinical trials of Soquelitinib in the United States, Australia, and Canada.
Soquelitinib is in Phase 2 clinical development for Atopic Dermatitis, with a Phase 2 trial currently recruiting participants. It has also advanced to a Phase 3 trial for relapsed or refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified and related T-cell lymphomas. Soquelitinib is not FDA approved and remains investigational.
Soquelitinib is being studied in three clinical trials. NCT07441395 is a Phase 2 trial in moderate to severe Atopic Dermatitis, recruiting 200 participants. NCT06561048 is a Phase 3 trial in relapsed or refractory peripheral T-cell lymphoma, recruiting 150 participants. NCT06345404 was a Phase 1 trial in Atopic Dermatitis that has been completed.
Soquelitinib is not FDA approved. It is an investigational drug in clinical development. It has received Orphan Drug and Fast Track designations from the FDA for its lymphoma indication, which are regulatory designations that do not constitute approval.