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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-16

Study Completion Date

2021-11-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Tildrakizumab 100 Milligrams (mg) in Participants With Moderate-Severe Chronic Plaque Psoriasis and Its Impact on Their Quality of Life (TRIBUTE)

NCT04229836

Plaque Psoriasis

COMPLETED PHASE4

A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011)

NCT01729754

Plaque Psoriasis

COMPLETED PHASE3

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

NCT04339595

Plaque Psoriasis

TERMINATED PHASE4

A Study to Evaluate the Efficacy and Safety of Subcutaneous MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-010)

NCT01722331

Plaque Psoriasis

COMPLETED PHASE3

Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasis

NCT03897088

Scalp Psoriasis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

tildrakizumab 100 mg

Group Type OTHER

Injections of tildrakizumab

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Injections of tildrakizumab

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No