Psoriasis Clinical Trials

• Subject has signed an Informed Consent Form (ICF) prior to any study-specific procedures being performed

• ≥ 18 years old, irrespective of their race and ethnicity.

• Body Mass Index (BMI) 18.0-40.0 kg/m2, inclusive, at screening.

• Participants are willing and able to adhere to study protocol requirements and restrictions including but not limited to scheduled outpatient visits, inpatient stay, laboratory tests, and 12-lead ECGs.

• The subject must be judged to be in good health by the investigator to participate in the study, based on clinical evaluations, including laboratory safety tests, medical history, physical examination, vital signs and 12-lead ECG completed at the screening visit and prior to the first dose of study drug.

• Female subject is postmenopausal (at least 1 year; to be confirmed by FSH if less than 2 years since last menstrual period), permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy) or if of childbearing potential and engaged in sexual activity that can result in pregnancy must agree to use any two of the highly effective contraception methods listed below. Male participants with a partner of childbearing potential must also agree to use any two of the highly effective contraception methods listed below between them and their partner. This criterion must be followed from screening visit to 6 weeks after the last dose in females and for 90 days after the last dose for males.

• The following applies to all female participants with childbearing potential and female partners of male participants enrolled in the study.

‣ Implantable progestogen-only hormone contraception associated with inhibition of ovulation.

‣ Intrauterine device.

‣ Intrauterine hormone-releasing system.

‣ Bilateral tubal occlusion.

‣ Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation:

‣ Oral

‣ Intravaginal

‣ Transdermal

‣ Injectable

∙ Progestogen-only hormone contraception (oral or injectable) associated with inhibition of ovulation.

∙ Vasectomized partner

∙ Sexual abstinence -this is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated about the duration of the study and the preferred and usual lifestyle of the participant.

∙ A combination of male condoms with either cervical cap, diaphragm, or sponge with spermicide (double-barrier methods)

• The following applies to all male participants in the study:

∙ Sexual abstinence- this is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence must be evaluated for the study and the participant's preferred and usual lifestyle.

∙ A combination of male condoms with either cervical cap, diaphragm, or sponge with spermicide (double-barrier methods).

∙ Vasectomy

• Negative serum B-human chorionic gonadotropin test at screening (for all females) and negative urine pregnancy at randomization (Day 1) (females of childbearing potential) prior to administration of investigational product.

• For Atopic Dermatitis Cohort:

• Diagnosis of AD at least 12 months prior to screening, as defined by the American Academy of Dermatology: Guidelines of care for the management of atopic dermatitis (Eichenfield 2014):

∙ EASI score ≥ 16 at Screening and baseline (Day 0)

‣ vIGA score of ≥3 at screening and baseline (Day 0)

‣ ≥10% of body surface area (BSA) involvement at screening and baseline (Day 0)

‣ Peak pruritis NRS≥4 (average score of daily scores 7 days before Day 0)

• History, documented by a physician and/or investigator, of inadequate response to existing topical medications within 6 months preceding screening, or history of intolerance to topical therapy as defined by at least 1 of the following:

∙ Inability to achieve good disease control defined as mild disease or better (e.g., IGA≤2) after use of at least a medium potency topical corticosteroid (TCS) for at least 4 weeks, or for the maximum duration recommended by the product prescribing information (e.g. 14 days for super potent TCS), whichever is shorter (Note: a TCS may be used with or without topical calcineurin inhibitors \[TCNIs\])

‣ Documented history of clinically significant adverse reactions with the use of TCS, such as skin atrophy, allergic reactions, or systemic effects that, in the opinion of the investigator, outweigh the benefits of retreatment

‣ Failed systemic therapies intended to treat AD within 6 months preceding screening (will be considered as having inadequate response to topical therapy)

⁃ Documented history of clinically significant adverse reactions with the use of TCS, such as skin atrophy, allergic reactions, or systemic effects that, in the opinion of the investigator, outweigh the benefits of retreatment

⁃ For Plaque Psoriasis Cohort:

⁃ Confirmed diagnosis of plaque psoriasis for at least 6 months prior to baseline (Day 0)

⁃ Plaque psoriasis involving ≥10% body surface area (BSA) in the affected skin other than the face and scalp at screening and baseline (Day 0)

⁃ Static Physician's Global Assessment (sPGA) score ≥3 at screening and baseline (Day 0)

⁃ PASI score of ≥12 at screening and baseline (Day 0)

⁃ Subject must be candidate for phototherapy or systemic therapy

⁃ Subject had no significant flare in psoriasis for at least 3 months before screening