Approval Probability
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Also known as diacerein 1% ointment
diacerein 1% · 2 trials · 5 indications
Number and percentage of participants with any treatment-emergent adverse event.
Bioanalytical analyses were performed to determine concentrations levels of diacerein and rhein in plasma using validated bioanalytical methods. For Cohort 1, blood samples were taken at pre-dose and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. For Cohort 2, blood samples were taken at pre-dose and 1, 2, 4, 6, and 8 hours post-dose. Trough PK samples were collected on any 2 available days from Days 3 through 9 for Cohort 1 only. Summary statistics for each scheduled time were only reported if at least 50% of subjects had quantifiable concentrations.
| Arm | Type | Description |
|---|---|---|
| Treatment period | EXPERIMENTAL | Subjects with active lesions as determined Investigator's clinical assessment, will initiate a cycle of applying diacerein 1% ointment once-daily, study medication, at home to their EBS lesions for 8 weeks. Following the Treatment Period, subjects will go Off Treatment for 8 weeks using only investigator approved bland, non-medicated emollient/moisturizer, routine cleansing products and sunscreens. As determined Investigator's clinical assessment, subjects may enter into another Treatment Period of 8 weeks. The duration of a subject's participation in the extension study may be as short as 32 weeks or as long as 52 weeks depending on the cycle initiation schedule for each individual subject. |
| Cohort 1 (Adolescents, Adults) | EXPERIMENTAL | Adolescent and adult subjects with EB (aged 12 years and older) received diacerein 1% ointment daily for 10 days. |
| Cohort 2 (Children) | EXPERIMENTAL | Children with EB (aged 4 to 11 years, inclusive) received diacerein 1% ointment daily for 10 days. |
| Name | Type | Description |
|---|---|---|
| diacerein 1% ointment | DRUG | Topically apply study medication to lesions identified by the Investigator that require. treatment |
Key Inclusion Criteria: * The subject is capable of understanding and complying with protocol requirements. * The subject or the subject's legally acceptable representative signs and dates a written, informed consent/assent form and any required privacy authorization prior to the initiation of any ...
Diacerein 1% is a topical small molecule ointment being developed for epidermolysis bullosa, a rare genetic skin blistering disease. It is applied to the skin and is in Phase 2 clinical development. Castle Biosciences, Inc. (ticker CSTL) is the developer.
Diacerein 1% is being studied for the treatment of epidermolysis bullosa, including epidermolysis bullosa simplex, dystrophic epidermolysis bullosa, and junctional epidermolysis bullosa. It is an investigational topical therapy and has not been approved for any indication.
Castle Biosciences, Inc., which trades under the ticker CSTL, is the developer of diacerein 1% ointment. The company is advancing the topical formulation for epidermolysis bullosa, a rare disease therapeutic area.
Diacerein 1% is in Phase 2 clinical development. It is an investigational product and is not FDA approved. Two clinical trials of the ointment have been completed, and no trials are currently active.
Two completed trials have evaluated diacerein 1%: NCT03472287, a Phase 1 pharmacokinetic study of diacerein and rhein after maximum use in patients with epidermolysis bullosa, and NCT03389308, a Phase 2 long term open-label safety study of the 1% ointment in epidermolysis bullosa simplex. Together they enrolled 62 participants.
Yes. Diacerein 1% and diacerein 1% ointment refer to the same investigational topical product from Castle Biosciences. The 1% designation describes the concentration of diacerein in the ointment formulation used in the epidermolysis bullosa clinical program.