Moderate to Severe Chronic Plaque PsoriasisPhase 2NCT00601107
A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis
A Phase 2 study testing Doxercalciferol in people with Moderate to Severe Chronic Plaque Psoriasis, run by Genzyme, a Sanofi Company at 19 sites in United States.
Trial summary
The purpose of this study was to evaluate the safety and effectiveness of an investigational drug called doxercalciferol in participants with moderate to severe chronic plaque psoriasis, in comparison with a placebo ("sugar pill"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Chronic Plaque Psoriasis
- What is being tested?
- Doxercalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 19 sitesUnited States
- Study dates
- Apr 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 static Physician's Global Assessment (PGA) of moderate or severe at the Day 1 visit
- Participant had a minimum PASI score of 10 at the Day 1 visit
- Participant was a candidate to receive systemic psoriasis therapy in the opinion of the Investigator
- Participant of childbearing potential, was willing to use an effective contraceptive method throughout the study, which included barrier methods, hormones, or intrauterine devices
Who cannot join
- Used vitamin D analogues, multivitamin supplements containing greater than (>) 400 international unit (IU) vitamin D, topical retinoids, topical pimecrolimus, and topical tacrolimus within 14 days prior to the Day 1 visit
- Used drugs known to influence serum calcium (such as lithium, digoxin, thiazide diuretics, teriparatide, bisphosphonates, and calcitonin) and multivitamin supplements containing calcium and/or calcium-containing antacids exceeding a total of 1 gram/day within 14 days prior to the Day 1 visit
- Used keratolytics or coal tar (except shampoo containing coal tar or salicylic acid) within 14 days prior to the Day 1 visit
- Used low potency topical corticosteroids (Classes VI and VII), except on the groin, scalp, palms, soles and face, within 14 days prior to the Day 1 visit
- Used medium potency topical corticosteroids (Classes III - V) or high potency topical corticosteroids (Classes I and II) within 14 days prior to the Day 1 visit
- Used systemic retinoids, systemic corticosteroids, methotrexate, cyclosporine, azathioprine, thioguanine or other systemic immunosuppressant agents within 28 days prior to the Day 1 visit
Show all 21Show fewer
- Used phototherapy, including Ultraviolet B within 14 days or Psoralen plus Ultraviolet A within 28 days prior to the Day 1 visit
- Used a biological agent (including, but not limited to, etanercept, adalimumab, efalizumab, infliximab, or alefacept) within 5 half-lives of the drug prior to the Day 1 visit
- Used systemic antibiotics within 14 days prior to the Day 1 visit. Antibiotic treatment of infections during the Treatment Period was not excluded
- Used investigational drugs within 28 days prior to the Day 1 visit
- Current erythrodermic, guttate, generalized pustular, unstable psoriasis or other chronic active skin conditions that may interfere with the study
- Screening visit laboratory result exceeded the following limits: alanine transaminase (ALT) or aspartate transaminase (AST) >1.5 times the upper limit of normal (ULN); bilirubin >ULN; serum creatinine, calcium, or phosphorus >ULN; spot urine calcium/creatinine ratio >0.4
- History of nephrolithiasis
- Chronic kidney disease as evidenced by a calculated glomerular filtration rate (GFR) less than (<) 60 milliliter/minute/1.73 square meter (mL/min/1.73 m^2) at the screening visit
- Symptomatic coronary or cerebral vascular disease, human immunodeficiency virus, active viral hepatitis, or any other clinically significant, unstable medical condition that would interfere with the completion of the study
- Clinically significant electrocardiogram (EKG) abnormality at screening
- Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy was not an exclusion
- Active ethanol or drug abuse, excluding tobacco use
- Active severe psychiatric illness that could interfere with the conduct of the study
- Pregnant or breast-feeding women
- Known allergy or hypersensitivity to vitamin D or other ingredients in the study drug formulation
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Study site
Albuquerque, New Mexico
Study site
Alpharetta, Georgia
Study site
Andover, Massachusetts
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
East Windsor, New Jersey
Study site
Greer, South Carolina
Study site
Hot Springs, Arizona
Study site
Indianapolis, Indiana
Study site
Irvine, California
Study site
Little Rock, Arkansas
Study site
Nashville, Tennessee
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Santa Monica, California
Study site
St Louis, Missouri
Study site
Stony Brook, New York
Study site
Troy, Michigan
Study site
West Bloomfield, Michigan
About this study
Official title: A Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Efficacy and Safety of Doxercalciferol Capsules in the Treatment of Subjects With Moderate to Severe Chronic Plaque Psoriasis
The purpose of this study was to evaluate the safety and effectiveness of an investigational drug called doxercalciferol in participants with moderate to severe chronic plaque psoriasis, in comparison with a placebo ("sugar pill"). All study related care was provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation was 28 weeks.
Read the detailed description
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging, parallel group study to evaluate the efficacy and safety of doxercalciferol given orally, once daily for 24 weeks to participants with moderate to severe chronic plaque psoriasis. Participants were randomized and stratified by site and Psoriasis Area Severity Index (PASI) score to one of three active treatment groups or to the placebo group.
- Being tested
- Doxercalciferol, Placebo
- Keywords
- psoriasis, psoriasis vulgaris, plaque psoriasis, chronic plaque psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxercalciferolDrug
Also called Hectorol®
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Doxercalciferol 2.5 mcg/day | Experimental | Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24. Receives: Drug: Doxercalciferol |
| Doxercalciferol 5 mcg/day | Experimental | Doxercalciferol 5 mcg capsules orally once daily up to Week 24. Receives: Drug: Doxercalciferol |
| Doxercalciferol 7.5 mcg/day | Experimental | Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24. Receives: Drug: Doxercalciferol |
| Placebo | Placebo comparator | Placebo matching to doxercalciferol capsules orally once daily up to Week 24. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at 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].
Measured: Week 12 or Early Termination
Secondary outcomes (2)
Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 24 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].
Measured: 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
Static PGA of psoriasis is scored on a 5-point scale (0 = clear to 4 = severe), reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. Clear (erythema: no, scale: no, induration: no thickness); Almost Clear (erythema: light pink, scale: fine scale, induration: barely palpable); Mild (erythema: light red, scale: coarse scale on most lesions, induration: slight but visible elevation, indistinct edges); Moderate (erythema: red, scale: coarse adherent scale predominates, induration: moderate elevation with edges); and Severe (erythema: dark red to purple, scale: thickened adherent scale, induration: marked thickness distinct and pronounced edges). Percentage of participants with static PGA score of clear or almost clear are reported.
Measured: Week 12 or Early Termination, Week 24 or Early Termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Moderate to Severe Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601107
- Sponsor's protocol ID
- HECTPS02507
- Status last verified
- Apr 2014
- First submitted
- 15 Jan 2008
- Last updated
- 5 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Efficacy and Safety of Doxercalciferol Capsules in the Treatment of Subjects With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00601107
- Acronym / sponsor ID
- HECTPS02507
- Keywords
- psoriasis, psoriasis vulgaris, plaque psoriasis, chronic plaque psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Jan 2008 (estimated)
- Results
- Posted 5 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the safety and effectiveness of an investigational drug called doxercalciferol in participants with moderate to severe chronic plaque psoriasis, in comparison with a placebo ("sugar pill"). All study related care was provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation was 28 weeks.
Detailed description
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging, parallel group study to evaluate the efficacy and safety of doxercalciferol given orally, once daily for 24 weeks to participants with moderate to severe chronic plaque psoriasis. Participants were randomized and stratified by site and Psoriasis Area Severity Index (PASI) score to one of three active treatment groups or to the placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Doxercalciferol 2.5 mcg/day | Experimental | Drug: DoxercalciferolDoxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24. |
| Doxercalciferol 5 mcg/day | Experimental | Drug: DoxercalciferolDoxercalciferol 5 mcg capsules orally once daily up to Week 24. |
| Doxercalciferol 7.5 mcg/day | Experimental | Drug: DoxercalciferolDoxercalciferol 7.5 mcg capsules orally once daily up to Week 24. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matching to doxercalciferol capsules orally once daily up to Week 24. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 static Physician's Global Assessment (PGA) of moderate or severe at the Day 1 visit
- Participant had a minimum PASI score of 10 at the Day 1 visit
- Participant was a candidate to receive systemic psoriasis therapy in the opinion of the Investigator
- Participant of childbearing potential, was willing to use an effective contraceptive method throughout the study, which included barrier methods, hormones, or intrauterine devices
Key exclusion criteria (21 listed)
- Used vitamin D analogues, multivitamin supplements containing greater than (>) 400 international unit (IU) vitamin D, topical retinoids, topical pimecrolimus, and topical tacrolimus within 14 days prior to the Day 1 visit
- Used drugs known to influence serum calcium (such as lithium, digoxin, thiazide diuretics, teriparatide, bisphosphonates, and calcitonin) and multivitamin supplements containing calcium and/or calcium-containing antacids exceeding a total of 1 gram/day within 14 days prior to the Day 1 visit
- Used keratolytics or coal tar (except shampoo containing coal tar or salicylic acid) within 14 days prior to the Day 1 visit
- Used low potency topical corticosteroids (Classes VI and VII), except on the groin, scalp, palms, soles and face, within 14 days prior to the Day 1 visit
- Used medium potency topical corticosteroids (Classes III - V) or high potency topical corticosteroids (Classes I and II) within 14 days prior to the Day 1 visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxercalciferolAlso: Hectorol® | Drug | Doxercalciferol 2.5 mcg/day, Doxercalciferol 5 mcg/day, Doxercalciferol 7.5 mcg/day |
| Placebo | Drug | Placebo |
Primary outcome
Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 12 or Early Termination
Time frame: 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].
2 secondary outcomes
Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 24 or Early Termination
Time frame: 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
Time frame: Week 12 or Early Termination, Week 24 or Early Termination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Genzyme, a Sanofi Company
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxercalciferol in people with Moderate to Severe Chronic Plaque Psoriasis, run by Genzyme, a Sanofi Company at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 12 or Early Termination (time frame: Week 12 or Early Termination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2014.