Deucravacitinib Rosacea

Last updated: January 22, 2025
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Trial Not Available

Phase

2

Condition

Rosacea

Treatment

Placebo

Deucravacitinib

Clinical Study ID

NCT06532136
STUDY-24-00593
  • Ages > 18
  • All Genders

Study Summary

This will be a double-blind, randomized placebo-controlled study in which participants will be randomized 2:1 to receive 6 mg deucravacitinib or placebo once daily for 8 weeks, followed by an open label extension during which all participants will receive 6 mg deucravacitinib once daily for an additional 8 weeks. The open-label extension has been incorporated in order to ensure all participants receive benefit from the study, as well as to benefit from the intra-patient comparison of placebo to drug, and to provide longer-term clinical data.

The study will include 33 adult participants with moderate-to-severe Papulopustular Rosacea (PPR). participants will have baseline Investigator Global Assessment (IGA) score of at least 3 and at least 12 inflammatory lesions.

Beginning at Baseline/Week 0 enrolled participants will receive 6mg deucravacitinib or placebo once daily for 8 weeks. At week 8, those participants originally randomized to placebo will initiate dosing with 6mg deucravacitinib once daily for 8 weeks until Week 16. Participants previously randomized to deucravacitinib will continue to receive deucravacitinib for an additional 8 weeks until Week 16. All participants will return for visits at Weeks 4, 8, 12 and 16 following study treatment initiation for repeat clinical assessments, medication reviews, tape-strip collection, blood and urine sample collections, and monitoring for adverse events.

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

Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 01, 2024
Estimated Completion Date:
January 31, 2026

Study Description

After providing consent, all subjects will be assessed for study eligibility, which includes a review of the subjects past and current medical conditions, familial medical history and detailed review of past and current medications. Subjects will also undergo a review of past topical treatments/therapies for PPR, and clinical assessments (inflammatory lesion count, IGA, CEA, PSA). Subjects will have urine (for urinalysis) and blood (for Complete Blood Count with differential, Comprehensive Metabolic Panel, lipid panel, creatinine kinase, C-Reactive Protein, HIV, HCV and HBV) collected for safety analysis. In addition, subjects will be screened for tuberculosis via PPD or quantiferon gold testing, and pregnancy (if applicable) via serum pregnancy test.

Connect with a study center

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

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