A phase IV interventional study to assess the disease-modifying effect of long-term treatment with tildrakizumab in adult patients with moderate-to-severe plaque psoriasis

A phase IV interventional study to assess the disease-modifying effect of long-term treatment with tildrakizumab in adult patients with moderate-to-severe plaque psoriasis - MODIFY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003218-15-PL

Enrollment

Registered

2019-09-06

Start date

2019-11-03

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe plaque psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858

Interventions

Trade Name: Illumetri Product Name: Illumetri Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: TILDRAKIZUMAB CAS Number: 1326244-10-3 Other descriptive name: TILD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Provide written informed consent prior to perform any study-related activity 2. Has completed the long-term extension of the reSURFACE 2 study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

Exclusion criteria: 1. Patients unable to comply with the requirements of the study 2. Patients who in the opinion of the investigator should not participate in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: To describe blood and skin inflammatory biomarkers and its correlation with psoriasis disease severity over time after having discontinued long-term treatment with tildrakizumab;Secondary Objective: - To assess time to disease relapse in the overall and in the different tildrakizumab responder populations - To assess changes in disease status (PASI, BSA, Physician Global Assessment [PGA], nailPGA, and scalpPGA) from baseline and until the End of Study (EoS) - To assess changes in Patient Reported Outcomes (PROs) from baseline and until the EoS ;Primary end point(s): - Descriptive analysis of blood and skin inflammatory biomarkers (YES [presence of inflammatory biomarkers]/NO [no presence of inflammatory biomarkers]) at each visit - Proportion of patients with psoriasis relapse during the 96-week follow-up period (YES [relapse]/ NO [disease control]), where relapse is defined using the following thresholds: ? PASI >3* (in patients who had a PASI =3 at baseline) ? PASI >5* (in patients who had a PASI =5 at baseline) ? DLQI >5* (in patients who had a DLQI =5 at baseline) ? Initiation of any topical drug/medication for psoriasis†^ ? Initiation of any systemic therapy for psoriasis (biologic or non-biologic)† *Only to be considered at first occurrence †To be considered at every occurrence ^Only apply to topical drugs/medications (not soaps, shampoos, emollients, keratolytics, etc, will be included in this group);Timepoint(s) of evaluation of this end point: please see section E.5.1	—

Measure

Time frame

Main Objective: To describe blood and skin inflammatory biomarkers and its correlation with psoriasis disease severity over time after having discontinued long-term treatment with tildrakizumab;Secondary Objective: - To assess time to disease relapse in the overall and in the different tildrakizumab responder populations - To assess changes in disease status (PASI, BSA, Physician Global Assessment [PGA], nailPGA, and scalpPGA) from baseline and until the End of Study (EoS) - To assess changes in Patient Reported Outcomes (PROs) from baseline and until the EoS ;Primary end point(s): - Descriptive analysis of blood and skin inflammatory biomarkers (YES [presence of inflammatory biomarkers]/NO [no presence of inflammatory biomarkers]) at each visit - Proportion of patients with psoriasis relapse during the 96-week follow-up period (YES [relapse]/ NO [disease control]), where relapse is defined using the following thresholds: ? PASI >3* (in patients who had a PASI =3 at baseline) ? PASI >5* (in patients who had a PASI =5 at baseline) ? DLQI >5* (in patients who had a DLQI =5 at baseline) ? Initiation of any topical drug/medication for psoriasis†^ ? Initiation of any systemic therapy for psoriasis (biologic or non-biologic)† *Only to be considered at first occurrence †To be considered at every occurrence ^Only apply to topical drugs/medications (not soaps, shampoos, emollients, keratolytics, etc, will be included in this group);Timepoint(s) of evaluation of this end point: please see section E.5.1

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Secondary

Measure	Time frame
Secondary end point(s): - Time to relapse during the 96-week follow-up period, defining relapse as the above mentioned categories - Absolute PASI score and change from baseline in the absolute PASI score over time, from baseline EoS visit - Absolute BSA score and change from baseline in the absolute BSA score over time, from baseline to EoS visit - Absolute DLQI and DLQI-R scores and change from baseline in the absolute DLQI and DLQI-R scores over time, from baseline to EoS visit - Absolute PGA, nail PGA and scalp PGA scores and change in the absolute PGA, nail PGA and scalp PGA scores over time, from baseline to EoS visit - Absolute pain- and pruritus-NRS scores and change from baseline in the absolute pain- and pruritus-NRS scores over time, from baseline to EoS visit;Timepoint(s) of evaluation of this end point: please see section E.5.2	—

Measure

Time frame

Secondary end point(s): - Time to relapse during the 96-week follow-up period, defining relapse as the above mentioned categories - Absolute PASI score and change from baseline in the absolute PASI score over time, from baseline EoS visit - Absolute BSA score and change from baseline in the absolute BSA score over time, from baseline to EoS visit - Absolute DLQI and DLQI-R scores and change from baseline in the absolute DLQI and DLQI-R scores over time, from baseline to EoS visit - Absolute PGA, nail PGA and scalp PGA scores and change in the absolute PGA, nail PGA and scalp PGA scores over time, from baseline to EoS visit - Absolute pain- and pruritus-NRS scores and change from baseline in the absolute pain- and pruritus-NRS scores over time, from baseline to EoS visit;Timepoint(s) of evaluation of this end point: please see section E.5.2

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Countries

Poland

Contacts

Public ContactInternat. Clinical Trial Manager

Almirall S.A.

mireia.condeclaveria.external@almirall.com+34932912913

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026