The inhibition of TYK2 in paradoxical psoriasis. A clinical trial to evaluate the effect of Deucravacitinib in paradoxical psoriasis compared to placebo treatment.
Zusammenfassung der Studie
Our research project aims to study the efficacy of the drug Deucravacitinib for the treatment of paradoxical psoriasis compared to taking a placebo.
(BASEC)
Untersuchte Intervention
Participants will be randomly assigned to two groups, group A and group B. Group A will receive treatment with the Deucravacitinib 6 mg tablet, while members of group B will receive a tablet that has the same appearance but contains no active substance (a placebo). This medication must be taken orally once a day during the first four weeks. It is important to note that neither the participants nor the study staff will know to which treatment group each individual belongs.
For individuals with psoriasis or psoriatic arthritis, there is the possibility to continue beyond the first four weeks. At that point, all participants will receive the study medication, which must be taken orally once a day for an additional twelve weeks.
(BASEC)
Untersuchte Krankheit(en)
Paradoxical psoriasis is a rare side effect of biological treatment (anti-TNF) that requires discontinuation of the biological treatment. Currently, there is no specific treatment for paradoxical psoriasis.
(BASEC)
1. Adult (>18 years) 2. Clinical diagnosis of paradoxical psoriasis induced by TNF inhibitors, determined by medical history and confirmation of diagnosis by physical examination 3. Women of childbearing potential must use highly effective contraceptive methods throughout the study duration and for 28 days after the last dose of the study medication; and men must use a mechanical contraceptive method (condom) 4. The patient is in general good health 5. The patient is willing to undergo biopsies. (BASEC)
Ausschlusskriterien
1. Use of another anti-psoriatic treatment during the study (for some medications, there are withdrawal periods to observe) 2. Recent infection(s) requiring treatment with intravenous or oral anti-infectives. 3. A positive serological test for hepatitis B, hepatitis C, or HIV; Active tuberculosis 4. History of lymphoproliferative disease or malignant tumor in the last 5 years 5. Pregnant or breastfeeding patient (BASEC)
Studienstandort
Lausanne, Zürich, Andere
(BASEC)
Buochs
(BASEC)
Sponsor
Dermatologie CHUV
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Curdin Conrad
+41 21 314 70 60
curdin.conrad@clutterchuv.chDermatologie CHUV
(BASEC)
Allgemeine Auskünfte
CHUV centre hospitalier universitaire vaudois,
+41 21 3143427;+41 21 3143427
curdin.conrad@clutterchuv.ch(ICTRP)
Allgemeine Auskünfte
CHUV centre hospitalier universitaire vaudois
(ICTRP)
Wissenschaftliche Auskünfte
CHUV centre hospitalier universitaire vaudois,
+41 21 3143427;+41 21 3143427
curdin.conrad@clutterchuv.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
11.04.2024
(BASEC)
ICTRP Studien-ID
NCT06281106 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
TYK2 inhibition in paradoxical psoriasis (TYPP) (BASEC)
Wissenschaftlicher Titel
Tyrosine Kinase 2 (TYK2) Inhibition in Paradoxical Psoriasis A Randomized, Double-blind, Placebo-controlled Multi-center Study Evaluating the Effect of Deucravacitinib on Severity of Psoriasis in Patients With Paradoxical Psoriasis (ICTRP)
Öffentlicher Titel
TYK2 Inhibition in Paradoxical Psoriasis (ICTRP)
Untersuchte Krankheit(en)
Psoriasis (ICTRP)
Untersuchte Intervention
Drug: Deucravacitinib (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
1. Clinical diagnosis of Paradoxical Psoriasis caused by anti-TNF treatment, with with
Investigator Global Assessment = 2 and Body Surface Area = 2%
2. Females who are of child-bearing potential should be practicing highly-effective
contraception methods throughout the study and for 28 days after the last dose of
study drug
3. Male subjects with a mechanical contraceptive method
4. be in good health
5. be willing to have skin biopsies taken
Exclusion Criteria:
1. Use of any other anti-psoriatic therapy. Certain washout periods of treatments needs
to be respected
2. Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30
days prior to the Baseline visit or oral anti-infectives within 14 days prior to the
Baseline visit
3. A positive serology test for hepatitis B, hepatitis C, HIV
4. History of lymphoproliferative disease or of malignancy within the past 5 years.
5. Chronic recurring bacterial infections or active tuberculosis
6. Positive pregnancy test at Screening and at the Baseline visit
7. Female subjects who are pregnant or breast-feeding or considering becoming pregnant
during the study
8. History of clinically significant alcohol or drug abuse in the last 12 months
9. Known hypersensitivity to Deucravacitinib or any of its excipients
10. Current severe progressive or uncontrolled disease
11. Live vaccine within 12 weeks before Baseline Visit. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Paradoxical Psoriasis Investigator Global Assessment (ICTRP)
Paradoxical Psoriasis Body Surface Area;Paradoxical Psoriasis palmoplantar Psoriasis Area and Severity Index;Paradoxical Psoriasis Scalp Investigator General Assessment;Psoriasis Area and Severity Index (PASI);American College of Rheumatology (ACR) Score (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Centre Hospitalier Universitaire Vaudois (ICTRP)
Weitere Kontakte
Curdin Conrad, Professor;Franziska Stuber, RN;Franziska Stuber, RN, franziska.stuber@chuv.ch, +41 21 3143427;+41 21 3143427, CHUV centre hospitalier universitaire vaudois, (ICTRP)
Sekundäre IDs
KOFAM 2023-01731, IM011-1118 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06281106 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar