None listed
Conditions
Brief summary
Psoriasis is an auto-immune disease of the skin, characterised by inflammation and thick patches of abnormal skin that are red, itchy, and scaly. In an effort to address the need for effective treatments for psoriasis, Samumed has developed a small molecule inhibitor of the Wnt pathway, SM04755. In addition to the critical role the Wnt pathway plays in tissue repair and regeneration, the Wnt pathway has been associated with inflammation and inflammatory diseases. SM04755 may play a role in attenuating acute inflammation and may have potential benefit in a variety of disease states such as psoriasis following topical administration. This new study is a Phase I, randomised double-blind placebo controlled, multiple ascending-dose (MAD) safety study of topical SM04755 in subjects with mild to moderate plaque psoriasis. SM04755 will be administered daily using a single-use topical solution formulation. Dose levels will be 15, 45 and 90 mg SM04755 per mL. Some subjects at each dose level will also receive placebo. Subjects will receive 28 days of daily drug administration and will be followed for approximately 28 days after last treatment. Samumed is conducting this trial to evaluate the safety, tolerability and systemic exposure of multiple doses of SM04755 topical solution in subjects who have mild to moderate plaque psoriasis. Safety monitoring throughout the study will allow for the estimation of the maximum recommended dose to be used for future studies conducted in individuals with psoriasis.
Interventions
This is a Phase I, randomised double-blind placebo controlled, multiple ascending-dose (MAD) safety study of topical SM04755 in subjects with mild to moderate plaque psoriasis.
This is the first study in humans where multiple doses of topical SM04755 will be given to subjects with the health condition of plaque psoriasis.
SM04755 will be supplied for daily use as a single-use topical solution formulation containing SM04755 in water, benzyl alcohol, propylene glycol, hydroxypropyl methylcellul
This is a Phase I, randomised double-blind placebo controlled, multiple ascending-dose (MAD) safety study of topical SM04755 in subjects with mild to moderate plaque psoriasis. This is the first study in humans where multiple doses of topical SM04755 will be given to subjects with the health condition of plaque psoriasis. SM04755 will be supplied for daily use as a single-use topical solution formulation containing SM04755 in water, benzyl alcohol, propylene glycol, hydroxypropyl methylcellulose and FD&C yellow #6. Subjects will receive 28 days of daily drug administration and will be followed for approximately 28 days after last treatment. The participant will apply 0.8mL solution topically to the target plaque lesion.. Dose escalation levels will be 15, 45 and 90 mg SM04755 per mL. Some subjects at each dose level will also receive placebo. During dose-escalation, subjects will receive either SM04755 or placebo.. The dose of SM04755 will be escalated in successive cohorts. Safety data for each cohort will be reviewed by the Safety Review Committee (SRC) prior to escalation to the next cohort and immediately following any Dose Limiting Toxicity (DLT). If 4 or more subjects in the active group experience a DLT at any dose level, no further subjects will be started at that dose, nor will higher doses be started. The MTD is defined as the highest dose level at which, of the 16 subjects enrolled in that dose cohort, less than 4 subjects in the active group develop a DLT. Compliance to the study protocol, applicable regulatory requirements and investigator's obligations will be monitored by Datapharm Australia Pty Ltd on behalf of the sponsor according to ICH GCP guidelines and standard operation procedures. All electronic clinical record forms will by 100% source verified against corresponding source documentation for each subject and includes but not limited to drug accountability and preparation procedures, appropriate consenting procedures and adherence to dosing procedures. At-site monitoring will be carried out according to the schedule outlined in the monitoring plan and includes for cause visits if need arises.
Sponsors
Samumed Pacific Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- BMI of 18 to 40, inclusive - Mild to moderate plaque psoriasis less than or equal to 10% body surface area - A single, non-intertriginous lesion with target plaque area great than or equal to 30 and less than or equal to 60 cm2. - Target Plaque Severity Score greater than or equal to 5 and less than or equal to 10 with Induration score greater than or equal to 2 and less than or equal to 4. - Willing to avoid extensive sun exposure, phototherapy, or use of a tanning salon - Subject must read and understand the informed consent form, and sign it prior to any study-related procedure being performed - Willingness to comply with all scheduled study visits, laboratory tests, contraception requirements, and other study procedures - Study cohort is open for randomization
Exclusion criteria
- Women who are pregnant or lactating. - Women of childbearing potential who are sexually active and are not willing to use birth control - Males who are sexually active and not willing to use a condom - History of allergy to investigational product/placebo ingredients - Recent use of any topical treatment for plaque psoriasis - Prior treatment with prescription medication for plaque psoriasis with no improvement in condition - Prior treatment of plaque psoriasis with biologic therapies - History of or current skin disease - History of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, musculoskeletal, immunologic, neurologic or dermatologic disease - History of malignancy within the last 5 years - Recent treatment with an investigational product - History of cardiac arrhythmia - Has current drug-induced psoriasis - Excessive hair in the treatment area - Unwilling to refrain from blood, plasma, platelet, or sperm donation - Clinically significant laboratory abnormalities at Screening - Clinically significant vital signs at Screening - Active infection of hepatitis B or C or HIV - Recent active infection or febrile illness - Recent serious illness requiring hospitalization - Positive urine drug screen result at Screening - Previous treatment with SM04755 - Subjects who have a current or pending disability claim, workers’ compensation, or litigation(s) - Subjects who are immediate family members of personnel directly affiliated with the study at any investigative site, or are directly affiliated with the study at any investigative site. - Subjects employed by Samumed, LLC, or any of its affiliates or development partners responsible for the conduct of the study
Outcome results
None listed