A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adu… (NCT05919082) | Clinical Trial Compass
CompletedPhase 3
A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis
China604 participantsStarted 2023-06-21
Plain-language summary
This study is conducted to assess the efficacy and safety of LEO 90100 when used on the body for the treatment of stable plaque psoriasis in native adult Chinese subjects, compared to Daivobet® ointment.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Chinese native
* Aged 18 or over
* A clinical diagnosis of stable plaque psoriasis for at least 6 months
* Stable plaque psoriasis on the trunk and/or limbs (excluding psoriasis on the face, scalp, genitals, and skin folds) involving 2-30% of the body surface at Day 1 (Visit 2) of the trial.
* Having a Physician Global Assessment of at least 'mild' at Day 1 (Visit 2)
* An mPASI score of at least 2 on the trunk and/or limbs at Day 1 (Visit 2)
* Women of childbearing potential must use an adequate form of birth control throughout the trial and for at least 8 weeks after last administration of IMP
* Male subjects with a female partner of childbearing potential must use adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
* Having a signed and dated informed consent.
Exclusion Criteria:
* Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the specified time periods prior to treatment assignment (depending on treatment)
* Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris within 4 weeks prior to treatment assignment
* Psoralen combined with ultraviolet A therapy (PUVA) within 4 weeks prior to treatment assignment
* Systemic treatment with Apremilast within 4 weeks prior to treatment assignment
* Ultraviolet B (UVB) therapy within 2 weeks prior to treatment assignment
* Topical treatment of psoria…
What they're measuring
1
Percentage of Participants With Physician's Global Assessment of Disease Severity (PGA) Score of 0 (Clear) or 1 (Almost Clear) at Day 29, With at Least a 2-point Reduction From Baseline