Long-Term Treatment Effect With Tildrakizumab in Participants With Plaque Psoriasis

NCT04339595 | Terminated Phase 4

• 2 other identifiers: M-14745-442019-003218-15
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the psoriasis disease control over time in participants who had received Tildrakizumab for at least the last 5 years and have discontinued it and to describe blood and skin inflammatory biomarkers and its correlation disease relapse.

Conditions

Plaque Psoriasis

Keywords

Human Antibody; Interleukin (IL) -23p19; Tildrakizumab; Moderate-To-Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (12)

• Number of Participants with Presence of Blood Inflammatory Biomarkers at Baseline

  Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  Baseline

• Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 12

  Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  Week 12

• Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 24

  Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  Week 24

• Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 36

  Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  Week 36

• Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 48

  Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  Week 48

• Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 60

  Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  Week 60

• Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 72

  Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  Week 72

• Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 84

  Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  Week 84

• Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 96/End of Study (EOS)

  Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  Week 96/End of study (EOS)

• Number of Participants with Presence of Skin Inflammatory Biomarkers at Baseline

  Inflammatory biomarkers will be assessed using a small piece of 4 millimeter (mm) of skin biopsy sample collected at Baseline (stored in RNAlater solution).

  Baseline

• Number of Participants with Presence of Skin Inflammatory Biomarkers at Week 48 or End of Study (EOS)

  Inflammatory biomarkers will be assessed using a small piece of 4 millimeter (mm) of skin biopsy sample collected at Week 48 or until the date of initiation of any systemic therapy including phototherapy whichever comes first (EOS) (stored in RNAlater solution).

  up to Week 48

• Percentage of Participants Who Experienced Psoriasis Relapse

  Psoriasis Area and Severity Index (PASI) is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). Relapse is defined using the following thresholds: PASI greater than (\>) 3 (participants who had a PASI lesser than or equal to \[\<=\] 3 at baseline); PASI \> 5 (participants who had a PASI \<= 5 at baseline); DLQI \> 5 (participants 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).

  Baseline up to Week 96/ End of study (EOS)

Secondary Outcomes (21)

• Time to Psoriasis Relapse

  Baseline up to Week 96(EOS)

• Absolute Psoriasis Area and Severity Index (PASI) Scores

  Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)

• Change from Baseline in Absolute Psoriasis Area and Severity Index (PASI) Scores

  Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)

• Absolute Body Surface Area (BSA) Scores

  Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)

• Change from Baseline in Absolute Body Surface Area (BSA) Scores

  Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS)

Study Arms (1)

Tildrakizumab

EXPERIMENTAL

Biological: Tildrakizumab

Interventions

Tildrakizumab BIOLOGICAL

Participants who have participated and completed the long-term extension phase of the reSURFACE 2 study (NCT01729754) and 12 weeks after the last Tildrakizumab dose will be included in the present study. Participants will not receive any study medication during the present study. Participants will remain in the study for 96 weeks or until they initiate any systemic therapy for psoriasis (including phototherapy), whichever occurs first.

Tildrakizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants provide signed written informed consent prior to perform any study-related activity
• Participants has completed the long-term extension of the reSURFACE 2 study

You may not qualify if:

• Participants unable to comply with the requirements of the study
• Participants who in the opinion of the investigator should not participate in the study

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (3)

Site 0003

Lodz, Poland

Location

Site 0001

Wroclaw, Poland

Location

Site 0002

Wroclaw, Poland

Location

MeSH Terms

Interventions

tildrakizumab

Study Officials

• Study Director

  Almirall, SAS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 9, 2020
• Study Start: January 29, 2020
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: December 8, 2021

Record last verified: 2021-11

Locations

PL (3)