AI-Powered Research

The patients eligible for inclusion in this study must fulfill all of the
following criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Male and female subjects aged 18 to 45 years of age inclusive, and otherwise
in good health as determined by medical history, physical examination, and
vital signs. Electrocardiograms and laboratory tests should be consistent with
normal values at screening.
3. Body weight between 50 and 120 kg, both inclusive, at screening.
4. Patients with papulo-pustular acne vulgaris (inflammatory acne):
- presenting at baseline with :
* 20 to 100 facial inflammatory lesions (papules, pustules and nodules),
* presenting at baseline and screening with
* no more than 2 facial inflammatory nodules or cysts,
* and a minimum of 10 non-inflammatory facial lesions (open and closed
comedones)
- who are candidates for systemic treatment and for whom in the opinion of the
investigator, an appropriate previous treatment with topical anti-acne
medication :
* failed,
* or was not well tolerated,
* or is not indicated (e.g., due to large body surface area affected, e.g.,on
the back)
5. Patients with Grade 3 (moderate) or Grade 4 (severe) IGA score confirmed by
central
reading of standardized image capture (Visia® system) by an independent
dermatologist
at screening and by the investigator*s clinical evaluation at baseline.
6. Able to communicate well with the investigator, to understand and comply
with the requirements of the study.

Exclusion Criteria

The patients fulfilling any of the following criteria are not eligible for
inclusion in this study:
1. Previous treatment with investigational drugs at the time of screening, or
within 4 weeks or 5 half-lives of baseline, whichever is longer; or more as
required by local regulations.
2. Previous treatment with any topical anti-acne therapy:
* prescription treatment within 2 weeks prior to baseline
* OTC within 1 week prior to baseline
The use of medicated anti-acne creams, medicated cleansers or medicated soaps
is prohibited.
3. Previous treatment with any oral/systemic anti-acne therapy:
* oral antibiotics, dapsone, oral zinc within 4 weeks prior to baseline,
retinoids, within 6 months prior to baseline and
* hormonal therapy (within 1 month prior to baseline.
If women of child bearing potential are using oral contraception, this
contraception can be used under certain conditions.
4. Previous treatment with systemic corticosteroids or immunomodulators (e.g.
cyclosporine, methotrexate, azathioprine) within 4 weeks prior to baseline.
5. Previous treatment with biologics (e.g anti-TNF* agents, anti-IL-1, or
anti-IL-17) within 3 months or 5 half-lives (whichever is longer) prior to
baseline.
6. Previous treatment with anti-IL-12/23 blocking agents (e.g. briakinumab and
ustekinumab or p19 antibodies) within 6 months prior to baseline.
7. Previous surgical, physical (such as ThermaClear*), light (including blue or
UV light, photodynamic therapy) or laser therapy within 4 weeks prior to
baseline.
8. Previous facial treatment with medium depth chemical peels (excluding home
regimens) within 3 months prior to baseline.
9. Concomitant medication(s) known to inhibit OAT3 or BCRP and that cannot be
discontinued or replaced by safe alternative medication within 5 half-lives or
1 week (whichever is longer) to baseline and for the duration of the study.
10. Any other forms of acne.
11. Any severe, progressive or uncontrolled medical or psychiatric condition or
other factors at randomization that in the judgment of the investigator
prevents the patient from participating in the study.
12. Active systemic infections (other than common cold) within 2 weeks prior to
baseline.
13. Subjects with eGFR <60 mL/min/1.73m2 at screening.
14. History or presence of crystals or stones in urine.
15. History or symptoms of malignancy of any organ system, treated or
untreated, within the past 5 years.
16. Chronic infection with Hepatitis B or C.
17. History of auto-immune or immunodeficiency diseases, or a positive HIV test
result at screening.
18. Pregnant or nursing women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive hCG laboratory test.
19. Women of child-bearing potential, unless they are using basic methods of
contraception during dosing of study treatment.
20. Sexually active males must use a condom during intercourse while taking
drug and for 2 weeks after stopping study medication and should not father a
child in this period.
21. History of drug abuse or unhealthy alcohol use.
22. Donation or loss of 400 ml or more of blood within 8 weeks prior to
baseline, or longer if required by local regulation.
23. Inability or unwillingness to undergo repeated venipunctures.
24. Any surgica

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Baseline-adjusted total inflammatory facial lesion count at Week 12</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Number and severity of adverse events</p><br>

Updated 4/15/2024

Home Terms & Conditions Privacy Policy