NCT06030076 A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis
| NCT ID | NCT06030076 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Almirall, S.A. |
| Condition | Plaque Psoriasis |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-09-06 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-09-06 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main aim of this study is to assess the effects of switching from another biologic to tildrakizumab on patient-reported outcomes and to assess psoriasis intensity, patient's quality of life prior and after switching and the individual rationales for switching biologics.
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent. 2. \>=18 years of age. 3. Moderate-to-severe plaque psoriasis currently treated with a biologic therapy (TNFα antagonist, IL12/23 antagonist, IL17 antagonist). 4. Switch to tildrakizumab due to: 1. primary or secondary treatment failure (PASI \>= 3 or ΔPASI \< 75 and/or DLQI \> 5) 2. adverse events, contraindication, intolerance 3. patient wish (dosing regimen), lack of adherence, or other, including nonmedical reason 5. Treatment with tildrakizumab planned in the frame of clinical practice. Exclusion Criteria: 1. Patient appears to be unwilling or unable to comply with the requirements of the study or who, in the opinion of the Investigator, should not participate in the study. 2. \>=3 previous biologic treatments in the last 3 years. 3. Participation in a clinical trial simultaneous to participation in SW-ATCH. 4. Any condition preventing prescription of Tildrakizumab according to the SmPC, including but not restricted to any contraindication or history of hypersensitivity or intolerance. 5. Patient dependent on the Investigator. 6. Previous treatment with Tildrakizumab.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06030076 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Plaque Psoriasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06030076 currently recruiting?
Yes, NCT06030076 is actively recruiting participants. Contact the research team at medicalat@almirall.com for enrollment information.
Where is the NCT06030076 trial being conducted?
This trial is being conducted at Graz, Austria.
Who is sponsoring the NCT06030076 clinical trial?
NCT06030076 is sponsored by Almirall, S.A.. The trial plans to enroll 50 participants.
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