Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
alitretinoin · 2 trials · 2 indications
The investigator assigned PGA grades according to a 5-point scale (clear \[not detectable\], almost clear \[less than 10% of affected hand surface\], mild disease \[less than 10% of affected hand surface\], moderate disease \[10% to 30% of affected hand surface\], severe disease \[\>30% of affected hand surface\]). PGA ratings were based on an integrated clinical picture of signs, symptoms, and the extent of disease. Symptoms included erythema, scaling, hyperkeratosis/lichenification, vesiculation, edema, fissures, and pruritus/pain. The PGA scale ranges from 0 (no symptom) to 4 (severe disease). Participants were considered as responders when they had a PGA of clear or almost clear.
The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis \[PPP\]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value.
The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis \[PPP\]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value. PPPASI 50 response and PPPASI 75 response are defined as a 50% and 75% decrease, respectively, in the PPPASI score from Baseline.
| Arm | Type | Description |
|---|---|---|
| Alitretinoin | EXPERIMENTAL | Patients will receive alitretinoin 30mg capsule for up to 24 weeks |
| Placebo | EXPERIMENTAL | Patients will receive placebo 30mg capsule for up to 24 weeks |
| Active | ACTIVE_COMPARATOR | to receive study drug (alitretinoin, 20 patients) |
| Name | Type | Description |
|---|---|---|
| alitretinoin | DRUG | Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks |
| Placebo | DRUG | Patients receive matching placebo for up to 24 weeks |
Inclusion Criteria: * all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis * rated as severe by the physician * unresponsive to highly potent topical corticosteroids, such as clobetasol Exclusion Criteria: * patients whose disease is adequately controlled by sta...
Alitretinoin is an investigational small molecule being studied for the treatment of severe chronic hand eczema and for the pustular form of psoriasis. In clinical trials, it has been evaluated in patients with these dermatological conditions.
Alitretinoin is being developed by GSK plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol GSK.
Alitretinoin has completed a Phase 3 clinical trial for severe chronic hand eczema and a Phase 2 clinical trial for the pustular form of psoriasis. It remains an investigational drug and is not approved for any use.
Alitretinoin was studied in NCT00817063, a Phase 3 trial in 599 patients with severe chronic hand eczema in the United States, and in NCT01245140, a Phase 2 trial in 33 patients with pustular psoriasis in France, Germany, Netherlands, and the United Kingdom. Both trials are completed.
Alitretinoin is a retinoid, a class of compounds related to vitamin A. In clinical trials, it has been tested as a treatment for skin conditions including eczema and psoriasis.