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Trial record 2 of 2 for:    NCT01729754

Long-Term Treatment Effect With Tildrakizumab in Participants With Plaque Psoriasis (MODIFY)

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ClinicalTrials.gov Identifier: NCT04339595
Recruitment Status : Recruiting
First Posted : April 9, 2020
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Almirall, S.A.

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Biological: Tildrakizumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : January 29, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Tildrakizumab Biological: Tildrakizumab
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.




Primary Outcome Measures :
  1. Number of Participants with Presence of Blood Inflammatory Biomarkers at Baseline [ Time Frame: Baseline ]
    Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  2. Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 12 [ Time Frame: Week 12 ]
    Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  3. Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 24 [ Time Frame: Week 24 ]
    Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  4. Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 36 [ Time Frame: Week 36 ]
    Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  5. Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 48 [ Time Frame: Week 48 ]
    Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  6. Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 60 [ Time Frame: Week 60 ]
    Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  7. Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 72 [ Time Frame: Week 72 ]
    Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  8. Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 84 [ Time Frame: Week 84 ]
    Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  9. Number of Participants with Presence of Blood Inflammatory Biomarkers at Week 96/End of Study (EOS) [ Time Frame: Week 96/End of study (EOS) ]
    Inflammatory biomarkers will be assessed using blood serum/plasma sample collected for local safety analysis.

  10. Number of Participants with Presence of Skin Inflammatory Biomarkers at Baseline [ Time Frame: 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).

  11. Number of Participants with Presence of Skin Inflammatory Biomarkers at Week 48 or End of Study (EOS) [ Time Frame: up to Week 48 ]
    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).

  12. Percentage of Participants Who Experienced Psoriasis Relapse [ Time Frame: Baseline up to Week 96/ End of study (EOS) ]
    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).


Secondary Outcome Measures :
  1. Time to Psoriasis Relapse [ Time Frame: Baseline up to Week 96(EOS) ]
    Time to relapse is defined as the time interval between the last administration of Tildrakizumab and the relapse of psoriasis in days.

  2. Absolute Psoriasis Area and Severity Index (PASI) Scores [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS) ]
    The 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).

  3. Change from Baseline in Absolute Psoriasis Area and Severity Index (PASI) Scores [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS) ]
    The 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). Change from baseline will be calculated by subtracting post-dose value from baseline value.

  4. Absolute Body Surface Area (BSA) Scores [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS) ]
    The BSA is a numerical score used to measure the total area of the body affected by psoriasis. The palm method will be applied: the participant's palm, including the five digits is used as a reference (representing approximately 1% of the total body surface area) and is used to repeatedly cover the lesions on the body. The investigator totals the number of palms required and then estimates the percentage (%) in each of the four body regions: head (including scalp) and neck (10%); upper extremities (20%); trunk (30%); and lower extremities (40%).

  5. Change from Baseline in Absolute Body Surface Area (BSA) Scores [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS) ]
    The BSA is a numerical score used to measure the total area of the body affected by psoriasis. The palm method will be applied: the participant's palm, including the five digits is used as a reference (representing approximately 1% of the total body surface area) and is used to repeatedly cover the lesions on the body. The investigator totals the number of palms required and then estimates the percentage (%) in each of the four body regions: head (including scalp) and neck (10%); upper extremities (20%); trunk (30%); and lower extremities (40%). Change from baseline will be calculated by subtracting post-dose value from baseline value.

  6. Absolute Dermatology Quality of Life Index (DLQI) Scores [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS) ]
    DLQI is a questionnaire to evaluate the impact on participant's quality of life due to psoriasis. It is composed of 10 items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 (no effect at all on participant's life) to 30 (extremely large effect on participant's life), with lower scores indicating better quality of life.

  7. Absolute Dermatology Quality of Life Index Scoring Modification (DLQI-R) Scores [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS) ]
    The DLQI-R is a scoring modification for the DLQI to better evaluate not relevant responses on the DLQI that could lead to underestimation of the impact on quality of life. DLQI-R is a scoring modification involves multiplying the original DLQI score by a conversion factor that increases with the number of not relevant responses.

  8. Change from Baseline in Absolute Dermatology Quality of Life Index (DLQI) Scores [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS) ]
    DLQI is a questionnaire to evaluate the impact on participant's quality of life due to psoriasis. It is composed of 10 items related to symptoms, feelings, daily activities, leisure, working/studying activities, personal relationships & opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores & ranges from 0 (no effect at all on participant's life) to 30 (extremely large effect on participant's life), with lower scores indicating better quality of life. Change from baseline will be calculated by subtracting post-dose value from baseline value.

  9. Change from Baseline in Absolute Dermatology Quality of Life Index Scoring Modification (DLQI-R) Scores [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS) ]
    DLQI-R is a scoring modification for the DLQI to better evaluate not relevant responses on the DLQI that could lead to underestimation of the impact on quality of life. DLQI-R, a scoring modification involves multiplying the original DLQI score by a conversion factor that increases with the number of not relevant responses. Change from baseline will be calculated by subtracting post-dose value from baseline value.

  10. Absolute Physician's Global Assessment (PGA) Scores [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS) ]
    The PGA is used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score.

  11. Change from Baseline in Absolute Physician Global Assessment (PGA) Scores [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS) ]
    The PGA is used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score. Change from baseline will be calculated by subtracting post-dose value from baseline value.

  12. Absolute Nail Physician Global Assessment (nPGA) Scores [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS) ]
    The nPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe nail psoriasis lesions. Only in participants with nail involvement the nPGA assessment will be performed.

  13. Change from Baseline in Absolute Nail Physician Global Assessment (nPGA) Scores [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS) ]
    The nPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe nail psoriasis lesions. Only in participants with nail involvement the nPGA assessment will be performed. Change from baseline will be calculated by subtracting post-dose value from baseline value.

  14. Absolute Scalp Physician Global Assessment (scPGA) Scores [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS) ]
    The scPGA score is used to assess the average severity of scalp psoriasis lesions. The scPGA is also 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe scalp psoriasis lesions. Only in participants with scalp involvement, the scPGA assessment will be performed.

  15. Change from Baseline in Absolute Scalp Physician Global Assessment (scPGA) Scores [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS) ]
    The scPGA score is used to assess the average severity of scalp psoriasis lesions. The scPGA is also 5-point scale ranging from 0 (clear) to 4 (severe), where higher score indicates severe scalp psoriasis lesions. Only in participants with scalp involvement, the scPGA assessment will be performed. Change from baseline will be calculated by subtracting post-dose value from baseline value.

  16. Absolute Pain-Numeric Rating Scale (Pain-NRS) and Pruritus-Numeric Rating Scale (Pruritus-NRS) Scores [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS) ]
    Both Pain-NRS and Pruritus-NRS are a unidimensional segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain or pruritus. The 11-point numeric scale of NRS ranges from 0 to 10, describing pain severity extremes scale 0 (no pain) to 10 (worst imaginable pain) and pruritus-severity extremes scale 0 (no pruritis) to 10 (worst imaginable pruritus), where higher scores indicates worse pain and pruritus.

  17. Change from Baseline in Absolute Pain- and Pruritus-Numeric Rating Scale (NRS) Scores [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and Week 96/ End of study (EOS) ]
    Both Pain-NRS and Pruritus-NRS are a unidimensional segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain or pruritus. The 11-point numeric scale of NRS ranges from 0 to 10, describing pain severity extremes scale 0 (no pain) to 10 (worst imaginable pain) and pruritus-severity extremes scale 0 (no pruritis) to 10 (worst imaginable pruritus), where higher scores indicates worse pain and pruritus. Change from baseline will be calculated by subtracting post-dose value from baseline value.

  18. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 96/ End of study (EOS) ]
    An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death, or is life threatening, or requires in participant hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is any other medically important event.

  19. Number of Participants with Clinically Significant Abnormalities in Physical Examination [ Time Frame: Baseline up to Week 96/ End of study (EOS) ]
    Physical Examination includes measuring height, weight, body mass index, waist circumference (cm), and waist hip ratio.

  20. Number of Participants with Clinically Significant Change from Baseline in Vital Signs [ Time Frame: Baseline up to Week 96/ End of study (EOS) ]
    Following vital signs with clinically significant observation will be measured as safety variables: diastolic and systolic blood pressure, heart rate, respiratory rate and body temperature. Change from baseline will be calculated by subtracting post-dose value from baseline value.

  21. Number of Participants with Clinically Significant Change from Baseline in Laboratory Parameters [ Time Frame: Baseline up to Week 96/ End of study (EOS) ]
    Clinically Significant hematology and biochemical parameters will be assessed. Change from baseline will be calculated by subtracting post-dose value from baseline value.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04339595


Contacts
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Contact: Ignasi Pau-Charles +34 932 913 317 ignasi.pau@almirall.com

Locations
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Poland
Site 0001 Recruiting
Wroclaw, Poland
Site 0002 Not yet recruiting
Wroclaw, Poland
Site 0003 Recruiting
Łódź, Poland
Sponsors and Collaborators
Almirall, S.A.
Investigators
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Study Director: Study Director Almirall, SAS
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Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT04339595    
Other Study ID Numbers: M-14745-44
2019-003218-15 ( EudraCT Number )
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Almirall, S.A.:
Human Antibody
Interleukin (IL) -23p19
Tildrakizumab
Moderate-To-Severe Plaque Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases