Phase
Condition
Rosacea
Treatment
Placebo
Deucravacitinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female participants ≥ 18 years of age at the time of signing the informedconsent document.
Participant is able to understand and voluntarily sign an informed consent documentprior to participation in any study assessments or procedures.
Participant is able to adhere to the study visit schedule and other protocolrequirements.
Diagnosis of PPR, baseline IGA ≥ 3, and baseline inflammatory lesion count ≥ 12
Participant agrees to discontinue all treatments for PPR from screening throughstudy completion aside from the study drug
Participant is judged to be in otherwise good overall health as judged by theinvestigator, based on medical history, physical examination, and laboratorytesting. (NOTE: The definition of good health means a participant does not haveuncontrolled significant co-morbid conditions).
Participant agrees not to receive a live vaccine during the study and for at least 4weeks after the last study drug dose.
Females of childbearing potential (FCBP) must have a negative pregnancy test atScreening and Baseline. While on the study drug and for at least 90 days after thelast dose of the study drug, male and female participants must be willing to takeappropriate contraceptive measures to avoid pregnancy or fathering a child. FCBP whoengage in activity in which conception is possible must use one of the approvedcontraceptive options described below:
Option 1: Any one of the following highly effective contraceptive methods:hormonal contraception (oral, injection, implant, transdermal patch, vaginalring); intrauterine device (IUD); tubal ligation; or partner's vasectomy OR
Option 2: Male or female condom (latex condom or nonlatex condom NOT made outof natural [animal] membrane [for example, polyurethane]); PLUS one additionalbarrier method: (a) diaphragm with spermicide; (b) cervical cap withspermicide; or (c) contraceptive sponge with spermicide.
The female participant's chosen form of contraception must be effective by the time the female participant is enrolled into the study.
Exclusion
Exclusion Criteria:
The presence of any of the following will exclude a participant from enrollment:
Participants with other skin diseases that would interfere with the study assessmentin the opinion of the investigator.
Active bacterial, fungal, or viral skin infection within 2 weeks from studyinitiation.
Participants has clinically significant (as determined by the investigator) renal,hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular,neurological, psychiatric, immunologic, or other major uncontrolled diseases (e.g.,malignancy, TB, HIV, HBV, HCV, thromboembolic events) that will affect the health ofthe participant during the study or interfere with the interpretation of studyresults.
Participant has previously received treatment with TYK2 inhibitor
Current topical or oral treatments (e.g., topical corticosteroids, topicalcalcineurin inhibitors, topical JAK inhibitors, topical metronidazole, topicalminocycline, topical ivermectin, topical azelaic acid, topical brimonidine, topicaloxymetazoline oral antibiotics) within 2 weeks of baseline
Use of systemic immunosuppressive medications, including, but not limited to,cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil,azathioprine, methotrexate, tacrolimus within 4 weeks of study initiation
History of adverse systemic or allergic reactions to any component of the studydrug.
Current participation in any other study with an investigational medication
Participant who is pregnant or breast feeding or plans on becoming pregnant orbreastfeeding
Participant has received a live vaccine < 4 weeks of Baseline/Week 0 visit.
ANY of the following abnormalities in the clinical laboratory tests at screening, asassessed by the study-specific laboratory and confirmed by a single repeat, ifdeemed necessary
Absolute neutrophil count of <1.2 x 109/L (<1200/mm3);
Hemoglobin <11.0 g/dL or hematocrit <33%;
Platelet count of <150 x 109/L (<150,000/mm3);
Absolute lymphocyte count of <0.80 x 109 /L (<800/mm3);
Estimated Glomerular Filtration Rate (eGFR) less than 60 mL/ml/min/1.73m2 basedon CKD-Epi 2021 (creatine equation);
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >2times the ULN;
Total bilirubin ≥ 1.5 times the ULN; participants with a history of Gilbert'ssyndrome may have a direct bilirubin measured and would be eligible for thisstudy provided the direct bilirubin is ≤ ULN
Study Design
Study Description
Connect with a study center
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
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