Clinical trial NCT03718299: A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2018-10-24
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

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.

Primary outcomes:
measure: Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale
timeFrame: baseline, week 28 and week 52
Secondary outcomes:
measure: Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale Over Time
timeFrame: baseline, weeks 4, 8, 12, 16, 40, 64
measure: Improvement in Quality of Life Measured by Change From Baseline in Dermatology Life Quality Index Over Time
timeFrame: week 64
measure: Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1
timeFrame: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64
measure: Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5
timeFrame: Baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64
measure: Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline
timeFrame: baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64
measure: Changes From Baseline in Percent Affected Body Surface Area
timeFrame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
measure: Change From Baseline in Static Physician's Global Assessment
timeFrame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
measure: Changes From Baseline Body Surface Area x Physician's Global Assessment Over Time
timeFrame: weeks 4, 8, 12, 16, 28, 40, 52, 64
measure: Changes From Baseline Psoriasis Area Severity Index (% of Psoriasis Area Severity Index Improvement From Baseline, Absolute Psoriasis Area Severity Index ) Over Time
timeFrame: baseline, weeks 4,16, 28 and 52
measure: Change From Baseline in Itch-Numeric Rating Scale
timeFrame: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64
measure: Change From Baseline in Scaling-Numeric Rating Scale
timeFrame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
measure: Change From Baseline in Pain-Numeric Rating Scale
timeFrame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
measure: Proportion of Patients With Itch Score of 0
timeFrame: weeks 4, 8, 12, 16, 28, 40, 52, and 64
measure: Proportion of Patients With Scaling Score of 0
timeFrame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
measure: Proportion of Patients With Pain Score of 0
timeFrame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
measure: Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
timeFrame: baseline, weeks 16, 28, 40, 52, 64
measure: Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
timeFrame: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64
measure: Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
timeFrame: weeks 4, 8, 12, 16, 28, 40, 52, 64
measure: Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale
timeFrame: weeks 4, 8, 12, 16, 28, 40, 52, 64
Other outcomes:
measure: Treatment-emergent AEs
timeFrame: baseline, weeks 4, 8, 12, 16, 28, 40, 52,,64
Locations:
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Grandville
country: United States
facility: Site 02
state: Michigan
Study officials:
References: