Acne

Phase 1

• Conditions: Inflammatory Acne; MedDRA version: 20.0Level: PTClassification code 10000496Term: AcneSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-003191-30-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-30
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

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 number 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
assessed by the investigator at screening and baseline.
6. Able to communicate well with the investigator, to understand and comply with the requirements of the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 3 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-TNFa 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 of kidney stones and/or repeated presence of crystals in
urine before drug administration.
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.(for example, Chemiluminescence and Polymerase Chain Reaction)
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. History of drug abuse or unhealthy alcohol use.
21. Donation or loss of 400 ml or more of blood within 8 weeks prior to baseline, or longer if required by local regulation.
22. Inability or unwillingness to undergo repeated venipunctures.
23. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.

Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified