ClinicalTrials.gov
ClinicalTrials.gov Menu

A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03718299
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

Brief Summary:
This is a Phase 4 multicenter, uncontrolled open-label study design. There will be a total of 10 study visits at Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Week 28, Week 40, Week 52 and Week 64, with subjects receiving tildrakizumab injections at Week 0, Week 4, Week 16, Week 28, Week 40, and Week 52. The total study duration will be approximately 64 weeks, excluding a screening period.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Injections of tildrakizumab Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Moderate to Severe Plaque Psoriasis
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
tildrakizumab 100 mg Drug: Injections of tildrakizumab
given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52




Primary Outcome Measures :
  1. Improvement in quality of life measured by change from baseline in Psychological General Well-Being scale [ Time Frame: baseline, week 28 and week 52 ]
    The Psychological General Well-Being scale is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.


Secondary Outcome Measures :
  1. Improvement in quality of life measured by change from baseline in Psychological General Well-Being scale over time [ Time Frame: baseline, weeks 4, 8, 12, 16, 40, 64 ]
  2. Improvement in quality of life measured by change from baseline in Dermatology Life Quality Index over time [ Time Frame: week 64 ]
  3. Proportion of subjects with Dermatology Life Quality Index score of 0 or 1 [ Time Frame: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64 ]
  4. Proportion of subjects with Dermatology Life Quality Index score <5 from baseline [ Time Frame: Baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64 ]
  5. Proportion of subjects with a reduction of ≥ 5 points in Dermatology Life Quality Index from baseline [ Time Frame: baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64 ]
  6. Changes from baseline in a Body Surface Area involvement,Static Physician's Global Assessment , and/or Body Surface Area x Physician's Global Assessment over time [ Time Frame: weeks 4, 8, 12, 16, 28, 40, 52, 64 ]
  7. Changes from baseline Psoriasis Area Severity Index (% of Psoriasis Area Severity Index improvement from baseline, absolute Psoriasis Area Severity Index ) over time [ Time Frame: baseline, weeks 4,16, 28 and 52 ]
  8. Change from baseline in itch, pain, and scaling using numerical rating scales over time [ Time Frame: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64 ]
  9. Proportion of patients with itch score of 0, pain score of 0, and scaling score of 0 over time [ Time Frame: weeks 4, 8, 12, 16, 28, 40, 52, and 64 ]
  10. Improvement from baseline in work productivity measured by change in Work Productivity and Activity Impairment scale over time [ Time Frame: baseline, weeks 16, 28, 40, 52, 64 ]
  11. Assessment of patient satisfaction with treatment measured by change from baseline in Treatment Satisfaction Questionnaire for Medication over time [ Time Frame: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64 ]
  12. Assessment of Tildrakizumab overall satisfaction over time using numerical rating scales [ Time Frame: weeks 4, 8, 12, 16, 28, 40, 52, 64 ]
  13. Assessment of Patient happiness with psoriasis control over time using numerical rating scale [ Time Frame: weeks 4, 8, 12, 16, 28, 40, 52, 64 ]

Other Outcome Measures:
  1. Treatment-emergent AEs [ Time Frame: baseline, weeks 4, 8, 12, 16, 28, 40, 52,,64 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Subjects are non-immunocompromised males or females 18 years of age or older.
  2. Subjects have ≥3% total body surface area plaque psoriasis.
  3. Subjects are candidates for phototherapy or systemic therapy.
  4. Subject must be diagnosed at least 6 months prior to entering the study.
  5. Females must be surgically sterile, postmenopausal for >5 years, or using a highly effective form of birth control (<1% failure rate), for at least 30 days prior to test article exposure, with a negative serum pregnancy test within 7 days before the first dose of test article.

Exclusion Criteria:

  1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
  2. Subject is younger than 18 years of age.
  3. Subjects with uncontrolled mental illness or active suicidal ideations based on baseline mental health questionnaire of choice.
  4. Subject is known, or suspected of being unable to comply with the study protocol, in the opinion of the investigator.
  5. Subject is currently enrolled in an investigational drug or device 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): NCT03718299


Contacts
Contact: Anna Houlihan (914)760-8796 anna.houlihan@sunpharma.com

Locations
United States, California
Site 01 Not yet recruiting
San Francisco, California, United States, 94118
Contact: Tina Bhutani, MD    415-476-4701    tina.bhutani@ucsf.edu   
United States, Michigan
Site 02 Not yet recruiting
Holland, Michigan, United States, 49424
Contact: Jayme Heim, NP    616-395-9379    heim.jayme@gmail.com   
Sponsors and Collaborators
Sun Pharma Global FZE

Responsible Party: Sun Pharma Global FZE
ClinicalTrials.gov Identifier: NCT03718299     History of Changes
Other Study ID Numbers: TIL2018-1
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases