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Doxercalciferol

Phase 2

Moderate to Severe Chronic Plaque Psoriasis | Small molecule | Dermatology |Sanofi|Last Updated: May 5, 2014

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment111

FDA Designations

No designations recorded

Clinical trial landscape

Doxercalciferol · 1 trial · 1 indication

Phase 2 1
NCT00601107A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe PsoriasisModerate to Severe Chronic Plaque Psoriasis
COMPLETED111 Analytics
PHASE2COMPLETED
A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis
Moderate to Severe Chronic Plaque Psoriasis
NCT00601107111
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Study Endpoints

Primary Endpoints

Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 12 or Early Termination
Week 12 or Early Termination

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\[l\].

Secondary Endpoints

Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 24 or Early Termination
Week 24 or Early Termination
Percentage of Participants With Static Physician's Global Assessment (PGA) Score of Clear or Almost Clear at Week 12, 24 or Early Termination
Week 12 or Early Termination, Week 24 or Early Termination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Doxercalciferol 2.5 mcg/dayEXPERIMENTALDoxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
Doxercalciferol 5 mcg/dayEXPERIMENTALDoxercalciferol 5 mcg capsules orally once daily up to Week 24.
Doxercalciferol 7.5 mcg/dayEXPERIMENTALDoxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
PlaceboPLACEBO_COMPARATORPlacebo matching to doxercalciferol capsules orally once daily up to Week 24.

Interventions

NameTypeDescription
DoxercalciferolDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites19

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...

Countries:United States
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Frequently asked questions about Doxercalciferol

What is Doxercalciferol used for?

Doxercalciferol is an investigational small molecule being studied for the treatment of moderate to severe chronic plaque psoriasis. It is a vitamin D analog that is being evaluated as a potential therapy for this dermatological condition. The drug is currently in Phase 2 clinical development.

Who makes Doxercalciferol?

Doxercalciferol is being developed by Sanofi, a multinational pharmaceutical company. Sanofi is listed on the stock exchange under the ticker symbol SNY. The company is conducting clinical trials to evaluate the safety and effectiveness of doxercalciferol for the treatment of moderate to severe chronic plaque psoriasis.

What phase is Doxercalciferol in?

Doxercalciferol is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated for the treatment of moderate to severe chronic plaque psoriasis.

What clinical trials is Doxercalciferol in?

Doxercalciferol has been studied in one completed clinical trial, identified by the identifier NCT00601107. This was a Phase 2, randomized, double-blind, placebo-controlled study that enrolled 111 participants with moderate to severe chronic plaque psoriasis. The trial was conducted in the United States and included adults aged 18 years and older.

Is Doxercalciferol FDA approved?

Doxercalciferol is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of moderate to severe chronic plaque psoriasis. The drug has completed one clinical trial, but it has not received regulatory approval and its safety and effectiveness have not been fully established.