If you are a male or female with a confirmed diagnosis of Atopic Dermatitis (AD) of at least 6 months aged between 18 and 65, then you may be eligible to participate in a study investigating a new drug being developed for the treatment of AD.
Study Payment* £3,325.
*Terms & Conditions apply.
Study Information
Simbec-Orion Clinical Pharmacology are currently running a three-part study to investigate the study drug, SYX-5219, for the treatment of Atopic Dermatitis (AD).
SYX-5219 is being developed as a potential treatment for a condition known as atopic dermatitis (AD); a skin condition often referred to as eczema which causes inflammation, redness and irritation of the skin. Currently, there are limited treatment options available for this condition (particularly for moderate to severe AD) which are considered long term and effective and there are no known cures. Therefore, there is an unmet need to develop potential new treatments which could be more effective.
The objectives of this study are to determine the safety, tolerability (degree to which side effects of a drug can be tolerated) and levels of SYX-5219 in the blood and urine when SYX-5219 is given in different conditions e.g., following administration of different dose strengths, single and multiple doses, in the presence and absence of food and in the intended patient population.
This study is split into three separate parts (Part 1, Part 2 and Part 3), and you will only participate in Part 3 of the study.
Part 3 Standard Group
The purpose of Part 3 is to evaluate the study objectives when SYX-5219 is administered as multiple doses across a period of 42 days at a selected dose strength.
Part 3 will consist of up to 45 participants with a confirmed diagnosis of AD for at least 6 months. The dose strength of SYX-5219 to be administered will be based upon a dose which has been evaluated and confirmed as safe in the previous parts of the study (conducted in healthy volunteers). Each participant will either receive SYX-5219 or a placebo (which contains no active drug) in the form of an oral capsule(s) which participants will swallow.
Screening Visit
Day -35 to Day -1
Clinic Visit 1 & First Dose Administration
Day 1
At Home Dosing
Day 2 – Day 42
Return Clinic Visits
Day 8, 15, 29 & 43
Follow Up Visit
Day 65 (14 days after last dose)
Eligibility Criteria
You may be eligible for this study as a participant if you have a current diagnosis of AD (for at least 6 months). Prior to your participation in this study, it is expected that you will have received the standard of care treatments for AD and during your participation in the study, any care which you are receiving will not be withheld, with the exception of certain medications which you will be required to stop taking in order to participate in the study. This is explained below, exactly which medications you will not be permitted to take and what period of time you will be required to stop taking these medications for.
Prior to dosing on Day 1, you will be required to stop any AD medications which you may be taking to manage your condition. Based on which medications you may be taking; you will be required to stop using these medications for certain periods of time prior to the first dose. You may refer to the table below which will outline exactly how long you need to stop taking certain types of medication for; however, if you are unsure, then please contact a member of the study team who will be able to advise accordingly.
At least 1 week prior to the Day 1 visit, you will be required to apply an unmedicated emollient of your choice on your skin (including on any areas which are affected by AD). You should continue to use this emollient throughout the study i.e., from at least 1 week prior to Day 1 until completion of the post-study follow up visit. If you are unsure as to which emollient you should use or whether the current product which you use is appropriate, then please ensure that you discuss with the study doctor at your screening visit who will be able to advise accordingly as to which is the most appropriate product to use.
Prohibited Medications & Restriction Windows
| Medication Type | From | Until |
|---|---|---|
| Rituximab or other medications which are classified as cell-depleting agents (e.g. Ocrelizumab, Ofatumumab, Obinutuzumab, Alemtuzumab, Daratumumab, Isatuximab, Belantamab mafodotin) | Within 6 months prior to the Day 1 visit | Completion of the post-study follow up visit |
| Biologics (e.g. Dupilumab (Dupixent), Tralokinumab (Adtralza / Adbry), Lebrikizumab, Nemolizumab) | Within 12 weeks or 5 half‑lives (whichever is longer) prior to the Day 1 visit | Completion of the post-study follow up visit |
| Steroids (oral, intravenous, intraarticular, rectal), medications associated with suppressing the immune system (methotrexate, cyclosporine, JAK inhibitors), blood products (immunoglobulins) (e.g. Cyclosporine , Methotrexate, Azathioprine, Mycophenolate mofetil, Prednisolone, methylprednisolone, Upadacitinib, Abrocitinib, Baricitinib.) | Within 4 weeks or 5 half‑lives (whichever is longer) prior to the Day 1 visit | Completion of the post-study follow up visit |
| Medications which may be applied to your skin i.e., topical medicated emollients or antibiotics (e.g. Doublebase Gel / Doublebase Once Emollient Gel / Doublebase Dayleve Gel , Epimax Rang, Cetraben Cream / Lotion / Ointment , Hydromol Cream / Ointment / Bath Additive, Zeroderma Rang, Emollin Spra, Epaderm Cream / Ointment, Balneum Intensive Cream / Balneum Cream, Zerobase Cream / Ointment, Zerodouble Cream, E45 Itch Relief Cream, Zerolive Emollient Cream / Gel, Oilatum Junior Bath Additive, Dermamist Spray, AproDerm Range, Diprobase Daily Moisturising Cream, Epizone Cream / Ointment, Dermatonics Natural Care Range, Epimax Paraffin-Free Ointment) | Within 1 week prior to the Day 1 visit | Completion of the post-study follow up visit |
| Diphenhydramine or hydroxyzine containing antihistamines (incl. corticosteroids, cyclosporin, tacrolimus, pimecrolimus, doxepin) | Within 1 week prior to the Day 1 visit | Completion of the post-study follow up visit |
| Changes to your leukotriene antagonist asthma treatment | Within 4 weeks prior to the Day 1 visit | Completion of the post-study follow up visit |
| Starting a new allergen specific immunotherapy regimen, or changing the regimen (preventative treatment for allergies) | Within 4 weeks prior to the Day 1 visit | Completion of the post-study follow up visit |
