RecruitingPhase 2ACTRN12624000746538

A Phase 2, Proof-of-concept, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AT-5214 in Subjects with Moderate to Severe Facial Acne Vulgaris

Sponsor

Atacama Therapeutics Australia, Pty Ltd.

Enrollment

100 participants

Start Date

Nov 13, 2024

Study Type

Interventional

Conditions

Acne vulgaris

Summary

This phase 2 study is a randomized, placebo-controlled, double-blind trial of an oral drug called AT-5214 vs placebo in participants with moderate to severe facial acne vulgaris. The study will assess the efficacy and safety of AT-5214.

Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Inclusion Criteria8

Males and females aged >/= 16years at time of signing informed consent.
Subject has oily skin as measured on three locations on the face using Sebometer, oily skin being defined as sebum level >100mcg/cm2.
Subject has moderate to severe (3 or 4 on IGA scale) facial acne vulgaris (including the nose).
Nonsmoker and/or ex-smoker who has discontinued smoking and/or use of nicotine-containing products, including vaping, for at least 6 months prior to Screening.
Subject has used the same type and brand of make-up, other facial products (including cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the study start and agrees to continue his/her other general skin and hair care products and regimen for the entire study.
Body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive).
Females of childbearing potential and not abstinent, must be willing to use at least 2 highly effective methods of contraception (hormonal contraception [stable dose for 3 months], intrauterine device/intrauterine hormone-releasing system, and barrier contraceptive method [diaphragm, cervical cap, contraceptive sponge, condom) from screening to 30 days after the last dose of study intervention. Females who are abstinent are not required to use a contraceptive method unless they become sexually active. Alternatively, females must be postmenopausal for >/=1 year or surgically sterile (with tubal ligation, hysterectomy, or bilateral oophorectomy) for >/=6 months.
Males with female partners of childbearing potential will agree to use barrier contraceptive (i.e., condom) and their female partners must use a highly effective method of contraception from screening to 90 days after the last dose of study intervention. Males also must refrain from sperm donations during this time period. Males who are abstinent are not required to use a contraceptive method unless they become sexually active.

Exclusion Criteria30

Subject has rosacea.
Presence of a significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
Abnormal blood pressure (resting heart rate < /=40 or >/=100 bpm or resting blood pressure <90/40 mmHg or >150/90 mmHg) at screening or before the first administration of study intervention.
Any other abnormal vital signs that are considered to be clinically significant by the investigator.
Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
Breast cancer within the past 10 years.
Any clinically significant laboratory abnormality at the screening visit or before the administration of the first dose of study intervention.
Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QTcF (QT with Fredericia’s correction) >/=450 msec.
Subject is pregnant, lactating, or is planning to become pregnant during the study.
Inability to tolerate oral medication.
Subject has used any of the following topical preparations on the face:
Topical anti-acne treatments including but not limited to over-the-counter acne cleaners or treatments, benzoyl peroxide, azelaic acid, sulfa-based products, corticosteroids and salicylic acid within 2 weeks of the initiation of treatment.
Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of the initiation of treatment.
Topical anti-acne treatments containing antibiotics within 4 weeks of the initiation of treatment.
Subject has used any of the following systemic medications:
Corticosteroids (including intramuscular and intralesional injections) within four weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four [4] weeks prior to the initiation of treatment).
Antibiotics within 4 weeks of the initiation of treatment with the exception of 5 days or less of antibiotic therapy during this period, but with no antibiotics use permitted within 1 week prior to the initiation of treatment.
Spironolactone within 4 weeks of the initiation of treatment with the exception of 5 days or less of spironolactone therapy during this period, but with no spironolactone use permitted within 1 week prior to the initiation of treatment.
Retinoid therapy within 6 months of the initiation of treatment.
Live vaccine(s) within 1 month before Screening or plans to receive such vaccines during the study.
Currently enrolled in an investigational drug or device study. Received an investigational drug or treated with an investigational device within 60 days or a minimum of 5 half-lives of the active investigational product prior to screening.
Positive prestudy drug screen.
Positive human immunodeficiency virus (HIV) or hepatitis C antibody test (HCV), or hepatitis B surface antigen (HBsAg) at screening or 3 months before enrollment.
Subject is a smoker or user of nicotine products. Ex-smokers are eligible as long as they stopped smoking at least 6 months prior to Screening.
Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
Facial procedures, including light treatment, lasers, peels and dermabrasion within 2 months prior to initiation of treatment and throughout the study.
Regular alcohol consumption within 6 months before the study defined, current evidence of substance dependence or self-reported alcoholic intake > 2 drinks/day for female subjects and > 3 drinks/day for male subjects.
Regular use of known drugs of abuse or a history of drug abuse within 12 months prior to screening.
Sensitivity to any of the study drug, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

This is a multi centre, double-blind, randomized, placebo-controlled proof-of-concept trial to evaluate the efficacy and safety of AT-5214 in participants with moderate to severe acne vulgaris. App

This is a multi centre, double-blind, randomized, placebo-controlled proof-of-concept trial to evaluate the efficacy and safety of AT-5214 in participants with moderate to severe acne vulgaris. Approximately 100 participants will be randomized in a 1:1 ratio to receive either AT-5214 oral tablet or an identical placebo oral tablet. Eligible participants who withdraw before the start of treatment will be replaced. Participants will receive oral AT-5214 or placebo tablets, 4 mg twice daily (BID) for 12 weeks. Participants will be provided with a diary card which they will be trained to use to record daily administration of the study drug. Compliance with the study treatment will be measured by return of unused drugs at the end of the treatment period (12 weeks).