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Also known as Hectorol®
Doxercalciferol · 1 trial · 1 indication
PASI score: range: 0 (no disease) to 72 (maximal disease). Body was divided into head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent area of skin involved (A) was estimated: 1 (\<10%) to 6 (90% - 100%), and severity was estimated by clinical signs: (erythema \[E\], induration \[I\], and desquamation \[D\]) on a scale: 0=no symptoms, 4=very marked. PASI score= 0.1 (E\[h\] + I\[h\] + D\[h\]) A\[h\] + 0.2 (E\[u\] + I\[u\] + D\[u\]) A\[u\] + 0.3 (E\[t\] + I\[t\] + D\[t\]) A\[t\] + 0.4 (E\[l\] + l\[I\] + D\[l\]) A\[l\].
| Arm | Type | Description |
|---|---|---|
| Doxercalciferol 2.5 mcg/day | EXPERIMENTAL | Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24. |
| Doxercalciferol 5 mcg/day | EXPERIMENTAL | Doxercalciferol 5 mcg capsules orally once daily up to Week 24. |
| Doxercalciferol 7.5 mcg/day | EXPERIMENTAL | Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24. |
| Placebo | PLACEBO_COMPARATOR | Placebo matching to doxercalciferol capsules orally once daily up to Week 24. |
| Name | Type | Description |
|---|---|---|
| Doxercalciferol | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Participant had moderate to severe chronic plaque psoriasis defined by a body surface area (BSA) involvement greater than or equal to (\>=) 10 percent (%) and plaques with at least a slight elevation above the surrounding normal skin at the Day 1 visit * Participant had a stat...
Doxercalciferol is being studied as an oral treatment for moderate to severe chronic plaque psoriasis. It is a small molecule vitamin D receptor agonist developed by Sanofi. The Phase 2 program evaluated doxercalciferol capsules in adults with this skin condition, and the drug remains investigational for this dermatology indication.
Doxercalciferol targets the vitamin D receptor, or VDR, acting as a VDR agonist. By binding and activating this nuclear receptor, the drug modulates vitamin D signaling pathways. This mechanism is the basis for its evaluation in moderate to severe chronic plaque psoriasis.
Sanofi develops doxercalciferol for moderate to severe chronic plaque psoriasis. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company sponsored the Phase 2 clinical program evaluating doxercalciferol capsules in adults with this dermatologic condition.
Doxercalciferol is in Phase 2 development for moderate to severe chronic plaque psoriasis. It is an investigational small molecule and has not been approved for this dermatology indication. The completed Phase 2 trial enrolled 111 participants and was randomized, double blind, and placebo controlled.
Doxercalciferol has been studied in one Phase 2 trial for moderate to severe chronic plaque psoriasis: NCT00601107, titled a study to evaluate the safety and effectiveness of doxercalciferol capsules in participants with moderate to severe psoriasis. The trial is completed, enrolled 111 adults, and was conducted in the United States.