Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||22 Years - 90 Years|
- - Adults (>21-year-old).
- - Diagnosed by dermatologist as plague-type PsO.
- - Having moderate to severe plague-type PsO as defined by the following: - Psoriasis Area and Severity Index (PASI) ≥12/72, - And, investigator Global Assessment Score (IGA) ≥3, - And, PsO involving body surface area involvement (BSA) ≥10% - And Candidate for phototherapy and/or systemic therapy.
- - Topical corticosteroid up to moderate potencies are allowed.
- - Able to provide informed consent.
- - Forms of PsO other than plaque-type.
- - Evidence of skin conditions at the time of the screening visit (e.g. eczema) that would interfere with evaluation of the effect of the investigational product on PsO.
- - Evidence of active tuberculosis or other active infections (like Hepatitis C/B), malignancy; active or known use of other immunosuppressive drugs (eg.
- - Previous exposure to any systemic immunosuppressants (eg.
- - History or current signs of a severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
- - Having current or history of malignancy, except non-melanoma skin cancer, within the previous 5 years that have been adequately treated.
- - History of inflammatory bowel disease.
- - Pregnancy or lactating mothers.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Singapore General Hospital|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Ying Ying Leung, MD|
|Principal Investigator Affiliation||Singapore General Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
First, the investigators hypothesize that a proportion of participants with moderate to severe PsO may sustain good outcomes when a short course of secukinumab is withdrawn. Second, the investigators hypothesize that they can identify the perturbations in the architecture of the immunome which are pathogenic, and to discriminate such perturbations based on treatment and clinical responses, thus distilling therapeutics and diagnostics signatures. Therefore, the objectives of this study are as follow: Specific aim 1: To describe the clinical course, sustained good outcomes, relapse rate, time to relapse and quality of life in PsO participants who stopped a 6-month short course treatment of secukinumab, till the end of 2-years. Specific aim 2: To identify the genomic and immunomics signatures in skin biopsies and blood in PsO participants who has good outcomes (PASI 75) at 6 months, comparing treatment vs.#46; pragmatic control. Specific aim 3: To identify the genomic and immunomics signatures in skin biopsies and blood in PsO participants who sustained good outcomes at 1 year after stopping secukinumab, compared to those relapsed.
Participants will be offered secukinumab as first-line systemic treatment for moderate to severe PsO. The indication for secukinumab will be equivalent to current registered indications. Standard dose of subcutaneous secukinumab for moderate to severe PsO will be given at 300 mg at weeks 0, 1, 2, 3, and 4, then monthly thereafter, for a total duration of 6 months. secukinumab will be withdrawn after 6 months. For some participants, there may be relapse of PsO. Relapses will be managed as per standard care.
Active Comparator: Standard Care
The management of PsO in the control arm will be the same as that in the standard care. The standard care for moderate to severe PsO in Singapore is to start either phototherapy, methotrexate, acitretin or cyclosporin A.
Biological: - secukinumab
Secukinumab for 6 months, given at weeks 0, 1, 2, 3 and 4, then monthly till 6 months. 300mg per administration, subcutaneously.
Drug: - Methotrexate
Oral tablet up to 15mg per week
Drug: - Cyclosporin A
Oral capsule up to 200mg per day
Drug: - Acitretin
Oral capsule up to 25mg per day
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.