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New treatment option for Plaque Psoriasis
Official title Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis
ClinicalTrials.gov ID: NCT04537689
What this study is testing
What is Ixekizumab?
Ixekizumab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for plaque psoriasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Psoriasis (PsO) is a systemic immune disease that affect 2-4% of the population worldwide. PsO causes tremendous burden in terms of quality of life, psychological impact, disability and work productivity of affected individuals.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 90
You may be able to join if
- 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,
You likely can't join if
- 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...
- Evidence of active tuberculosis or other active infections (like Hepatitis C/B), malignancy; active or known use of other immunosuppressive drugs...
- Previous exposure to any systemic immunosuppressants (eg. methotrexate) or phototherapy
- History or current signs of a severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic...
- Having current or history of malignancy, except non-melanoma skin cancer, within the previous 5 years that have been adequately treated.
See the full eligibility criteria
- 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. AIDS, rheumatoid arthritis, organ rejection etc) at the screening...
- Previous exposure to any systemic immunosuppressants (eg. methotrexate) or phototherapy
- 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.
- As treatment regimen is different, participants with evidence of PsA will be excluded
The study team makes the final eligibility decision.
Where it's taking place
- Outram Park, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Outram Park, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.