Benefits of tildrakizumab treatment for Romanian patients with severe plaque psoriasis observed in real-life
| ISRCTN | ISRCTN62368057 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62368057 |
| Secondary identifying numbers | TSP_IL_CBS20022023 |
- Submission date
- 02/10/2025
- Registration date
- 16/10/2025
- Last edited
- 16/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
The skin cells in people with psoriasis grow faster than normal, which leads to a buildup that forms these patches. Normally, skin cells renew every 3 to 4 weeks, but in psoriasis this happens in just a few days. The cause of psoriasis is related to the immune system mistakenly attacking healthy skin cells, causing inflammation and faster skin cell growth. It often runs in families and can be triggered or made worse by things like infections, stress, skin injuries, smoking, obesity, and alcohol. Psoriasis affects people differently; some have mild patches, while for others it can be severe and impact their quality of life. The disease usually comes and goes in cycles, with flare-ups followed by periods of less severe symptoms. Psoriasis can be associated with other health problems, such as depression, arthritis that affects the joints, and heart or metabolic issues. Treatments aim to reduce the symptoms and improve the patient's life, often involving medications that calm the immune system and reduce inflammation. A newer type of treatment targets specific parts of the immune system that cause psoriasis. For example, tildrakizumab is a medicine that blocks a protein called IL-23 involved in the inflammation process. This treatment has been shown to be safe and effective for many patients, even those who have other health problems along with psoriasis.
Who can participate?
Patients aged over 18 years with severe psoriasis who have already been prescribed tildrakizumab (Ilumetri®) treatment
What does the study involve?
Tildrakizumab (Ilumetri®) will be administered and patient demographic data will be collected during the screening visit where available (age, gender etc). All the assessments will be performed at the start of the study and at weeks 28, 52 and end of study visit.
What are the possible benefits and risks of participating?
The results of this study may help improve the safety and performance profile of the product. There is no specific and/or direct benefit from participating in this study. Participation in this study is voluntary.
The treatment strategy for the condition will be recommended by the treating physician. Thus, the physician may prescribe an alternative to the treatment already prescribed and decide to discontinue the study participation.
Where is the study run from?
Dermatology clinics or dermatology department in tertiary care centers within the territory of Romania during routine clinical practice settings.
When is the study starting and how long is it expected to run for?
March 2023 to May 2026
Who is funding the study?
Terapia SA a SUN PHARMA Company (Romania)
Who is the main contact?
Mrs Alina Iordache, alina.iordache@cebis-int.com
Contact information
Public, Scientific, Principal Investigator
47 Theodor Pallady
Bucharest
032275
Romania
| Phone | +40 (0)21 320 32 81 |
|---|---|
| alina.iordache@cebis-int.com |
Study information
| Study design | Open-label multicenter prospective non-comparative non-interventional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Open-label multicenter prospective non-comparative |
| Study setting(s) | Hospital, Other |
| Study type | Quality of life, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Real-life effectiveness, tolerability, and impact on quality of life of tildrakizumab in severe plaque psoriasis: a Romanian perspective |
| Study acronym | REAL |
| Study objectives | Primary objectives: Tildrakizumab effectiveness in subjects with severe plaque psoriasis treated according to the Summary of Product Characteristics (SmPC), current clinical practice, and National Therapeutic Protocol Secondary objectives: 1. Percentage of super-responder patients at week 28 visit 2. Tildrakizumab effectiveness in subjects with special areas involvement (e.g., scalp, nails, genitalia, palmo-plantar) 3. Tildrakizumab tolerability profile 4. Tildrakizumab impact on quality-of-life improvement from baseline |
| Ethics approval(s) |
Approved 15/11/2023, National Bioethics Committee for Medicinal Products and Medical Devices (Dr. Calistrat Grozovici street, no.6, district 2, Bucharest, 021105, Romania; +40 (0)213115382; secretariat@bioetica-medicala.ro), ref: 9SNI/04.10.2023 |
| Health condition(s) or problem(s) studied | Severe plaque psoriasis |
| Intervention | This non-interventional study will be conducted in patients with psoriasis by dermatologists across up to 40 centers according to routine clinical practice and provisions of the National Therapeutic Protocol. Data will be collected prospectively. Tildrakizumab (Ilumetri®) will be administered in accordance with approved SmPC. Patient demographic data would be collected during the screening visit where available (age, gender etc). All the assessments for primary and secondary objectives will be performed at baseline and periodically according to the National standards, routine clinical practice, and this study protocol. Each patient will be followed up under the study protocol until completing 16 months of tildrakizumab treatment or until tildrakizumab treatment interruption. Each patient will attend 10 visits. These will be in line with routine clinical practice in Romania. The recommended dose is 100 mg by subcutaneous injection at weeks 0, and 4 and every 12 weeks thereafter. In patients with certain characteristics (e.g., high disease burden, body weight ≥90 kg) 200 mg may provide greater efficacy. According to the National Therapeutic Protocol, for patients with a body weight ≥90 kg who after 3 months of treatment don’t obtain a satisfactory response or who during therapy start losing the response, a 200 mg dose can be used for a maximum period of 6 months and only once. |
| Intervention type | Other |
| Primary outcome measure | Proportion of patients achieving PASI 75, defined as 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) after treatment at week 28 |
| Secondary outcome measures | 1. Proportion of patients achieving PASI 75, defined as 75% reduction (improvement) in the PASI score after treatment at week 52 and end of study visit 2. Proportion of patients maintaining PASI 75 response, defined as the percentage of patients which continue to meet 75% reduction (improvement) in the PASI score after treatment at week 52 and end of study visit 3. Percentage of subjects achieving PASI 90 measured using the PASI 90% reduction (improvement) in the PASI score after treatment at week 28, 52 and end of study visit 4. Percentage of subjects achieving PASI 100 measured using the PASI 100% reduction (improvement) in the PASI score after treatment at week 28, 52 and end of study visit. 5. Special areas scores in patients with scalp psoriasis if applicable, measured using the Psoriasis Scalp Severity Index (PSSI) at baseline, week 28, 52 and end of study visit 6. Special areas scores for palm and sole psoriasis if applicable, measured using the Erythema, Scaling, Induration, Fissuring Scale (ESIFS) at baseline, week 28, 52 and end of study visit 7. Special areas score in patients with nail psoriasis if applicable, measured using the Nail Psoriasis Severity Index (NAPSI) at baseline, week 28, 52 and end of study visit 8. Absolute PASI score measured at baseline, week 28, 52 and end of study visit 9. Percentage of subjects with adverse events, drug-related treatment-emergent adverse events and change from baseline in laboratory parameters as specified in National Therapeutic Protocol, measured using AE forms at each study visit 10. DLQI score measured using the Dermatology Life Quality Index (DLQI) questionnaire at baseline, week 16, 28, 52 and end of study visit |
| Overall study start date | 29/03/2023 |
| Completion date | 01/05/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 400 |
| Key inclusion criteria | 1. Adult patients (>18 years) diagnosed with severe psoriasis 2. Eligible for Tildrakizumab (Ilumetri®) treatment according to SmPC and National Therapeutic Protocol and for whom decision of Tildrakizumab (Ilumetri®) prescription was done before enrolment in the study |
| Key exclusion criteria | 1. Patients who are not fulfilling the inclusion criteria according to the product SmPC and National Therapeutic Protocol 2. Patients participating in other trials |
| Date of first enrolment | 16/11/2023 |
| Date of final enrolment | 23/09/2024 |
Locations
Countries of recruitment
- Romania
Study participating centres
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Sponsor information
Industry
Blvd. Dimitrie Pompeiu no. 9-9A
Bucharest
020335
Romania
| Phone | +40 (0)372 179 600 |
|---|---|
| cristina.cristea2@sunpharma.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/05/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Not known yet |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the confidential nature of the data |
Editorial Notes
02/10/2025: Study's existence confirmed by the National Bioethics Committee for Medicinal Products and Medical Devices.
