Psoriasis, Plaque-typePhase 2NCT01891019
Thalidomide in the Treatment of Chronic Plaque Psoriasis.
A Phase 2 study testing Thalidomide oral in people with Psoriasis, Plaque-type, run by Wake Forest University at 1 site in United States.
Trial summary
The objective of this study is to obtain information on the effectiveness of thalidomide in psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Plaque-type
- What is being tested?
- Thalidomide oral
- Type of treatment
- Pill or oral medicine
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male or female subjects 18 years of age or older.
- Stable or worsening psoriasis that involves 5% or greater of total body surface area (BSA) involvement with a minimum PASI score of 8.
- Moderate to severe plaque-type psoriasis, defined by a minimum score of 1 for each of erythema, scaling, and plaque thickness (using a 0 - 4 scale).
- Patients receiving systemic retinoids, prednisone, methotrexate, or cyclosporine should be on a stable dose at least 28 days prior to the first dose of thalidomide.
- Patients receiving topical treatments should be consistent with such treatments throughout the study.
- The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
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- The ability to understand and sign a written informed consent form, which must be obtained prior to treatment.
- The ability to understand, agree to, and comply with the requirements of the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.).**
- (Because of the known teratogenic effects of thalidomide and in an effort to prevent to the greatest extent possible any chance of fetal exposure to thalidomide, THALOMID(thalidomide) is approved for marketing only under a special restricted distribution program approved by the FDA. Under this program, the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.), only prescribers and pharmacists registered with the program are allowed to prescribe and dispense thalidomide (Zeldis JB et al. 1999). In addition, patients must be advised of, agree to, and comply with the requirements of the S.T.E.P.S. Program. To monitor patient compliance with the S.T.E.P.S. program, all patients must complete the S.T.E.P.S. program informed consent and participate in a mandatory and confidential surveillance registry.)
Who cannot join
- Unstable psoriasis
- Unable or unwilling to meet all criteria for contraception as required in STEPS.
- Known allergy to thalidomide.
- Known history of neuropathy.
- Abnormal laboratory test results that the investigator feels would compromise patient safety or evaluation of drug safety.
- The introduction of drugs for other medical conditions which are known to affect psoriasis (e.g., lithium, beta-adrenergic blockers, etc.) during the period 4 weeks prior to and during the study period.
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- Use of any investigational therapy within the 4 weeks prior to the first dose of thalidomide.
- Expectation of exposure to strong sunlight during the course of the study (e.g. planned holiday in high sunlight area) or intention of sunbathing for prolonged periods of time during the course of the study.
- Current drug or alcohol abuse (drug screening not required).
- Medical conditions that preclude thalidomide therapy. Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina, 27157
About this study
The objective of this study is to obtain information on the effectiveness of thalidomide in psoriasis.
- Conditions
- Psoriasis, Plaque-type
- Being tested
- Thalidomide oral
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thalidomide oralDrug
Also called Thalomid
Thalidomide will be administered nightly, with each subject taking 2 capsules totaling 100 milligrams for the initial two weeks of treatment, 3 capsules totaling 150 milligrams for week 2 to week 4, and 4 capsules totaling 200 milligrams for week 4 to end of treatment. The subjects will take the medication for 12 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI) Score
The change from Baseline to Week 12 (or end of treatment) in the composite score (PASI) of the signs of psoriasis (erythema, scaling, plaque thickness).
Measured: 12 weeks
Secondary outcomes (1)
Subject Global Assessment
Investigator and Subject Global Assessment of Response at Weeks 2, 4, 8, 12 (or end of treatment) and at Week 16 (follow-up).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startApr 2003
- Primary completionSep 2005
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis, Plaque-typeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891019
- Sponsor's protocol ID
- 03-147
- Other IDs
- 21737
- Status last verified
- Aug 2018
- First submitted
- 27 Jun 2013
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalidomide in the Treatment of Chronic Plaque Psoriasis.
- ClinicalTrials.gov ID
- NCT01891019
- Acronym / sponsor ID
- 03-147
- Conditions
- Psoriasis, Plaque-type
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Sep 2005 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to obtain information on the effectiveness of thalidomide in psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects 18 years of age or older.
- Stable or worsening psoriasis that involves 5% or greater of total body surface area (BSA) involvement with a minimum PASI score of 8.
- Moderate to severe plaque-type psoriasis, defined by a minimum score of 1 for each of erythema, scaling, and plaque thickness (using a 0 - 4 scale).
- Patients receiving systemic retinoids, prednisone, methotrexate, or cyclosporine should be on a stable dose at least 28 days prior to the first dose of thalidomide.
- Patients receiving topical treatments should be consistent with such treatments throughout the study.
Key exclusion criteria (10 listed)
- Unstable psoriasis
- Unable or unwilling to meet all criteria for contraception as required in STEPS.
- Known allergy to thalidomide.
- Known history of neuropathy.
- Abnormal laboratory test results that the investigator feels would compromise patient safety or evaluation of drug safety.
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 |
|---|---|---|
| Thalidomide oralAlso: ThalomidThalidomide will be administered nightly, with each subject taking 2 capsules totaling 100 milligrams for the initial two weeks of treatment, 3 capsules totaling 150 milligrams for week 2 to week 4, and 4 capsules totaling 200 milligrams for week 4 to end of treatment. The subjects will take the medication for 12 weeks. | Drug | – |
Primary outcome
Psoriasis Area and Severity Index (PASI) Score
Time frame: 12 weeks
The change from Baseline to Week 12 (or end of treatment) in the composite score (PASI) of the signs of psoriasis (erythema, scaling, plaque thickness).
1 secondary outcome
Subject Global Assessment
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
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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.
Steve Feldman, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide oral in people with Psoriasis, Plaque-type, run by Wake Forest University at 1 site 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 9 inclusion and 10 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 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Psoriasis Area and Severity Index (PASI) Score (time frame: 12 weeks). 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 13 Aug 2018.