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

NCT03718299 | Completed Phase 4 Results FDA Drug

• 1 other identifier: TIL2018-1
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale

  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. The values reported are change in score from baseline.

  baseline, week 28 and week 52

Secondary Outcomes (19)

• Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale Over Time

  baseline, weeks 4, 8, 12, 16, 40, 64

• Improvement in Quality of Life Measured by Change From Baseline in Dermatology Life Quality Index Over Time

  week 64

• Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1

  baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64

• Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5

  Baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64

• Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline

  baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64

Other Outcomes (1)

• Treatment-emergent AEs

  baseline, weeks 4, 8, 12, 16, 28, 40, 52,,64

Study Arms (1)

tildrakizumab 100 mg

OTHER

Drug: Injections of tildrakizumab

Interventions

Injections of tildrakizumab DRUG

given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52

tildrakizumab 100 mg

Eligibility Criteria

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

You may qualify if:

• Subjects are non-immunocompromised males or females 18 years of age or older.
• Subjects have ≥3% total body surface area plaque psoriasis.
• Subjects are candidates for phototherapy or systemic therapy.
• Subject must be diagnosed at least 6 months prior to entering the study.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (2)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Site 02

Grandville, Michigan, 49418, United States

Location

Related Publications (1)

• Bhutani T, Koo J, Heim J, Bhatia N, Mathew J, Ferro T, Vasquez JG. Improvements in Psoriasis-Related Work Productivity with Tildrakizumab: Results from a Phase 4 Real-World Study in Patients with Moderate-to-Severe Plaque Psoriasis. Dermatol Ther (Heidelb). 2024 Apr;14(4):1019-1025. doi: 10.1007/s13555-024-01131-1. Epub 2024 Apr 4.

  PMID: 38575729 DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Head-Clinical Development
• Organization: Sun Pharmaceutical Industries Limited

clinical.trials@sunpharma.com

2266455645

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: October 15, 2018
• First Posted: October 24, 2018
• Study Start: July 16, 2019
• Primary Completion: November 2, 2021
• Study Completion: November 5, 2021
• Last Updated: February 23, 2023
• Results First Posted: February 23, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)