A Study Evaluating the Effects of GLPG3667 Given as an Oral Treatment for 4 Weeks in Adults With Moderate to Severe Plaque Psoriasis

NCT ID: NCT04594928

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-19
• Study Completion Date: 2021-05-04

Brief Summary

The purpose of this research study is to assess the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG3667 in multiple daily oral doses in subjects with moderate to severe plaque psoriasis.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

GLPG3667 Dose A

Daily doses of GLPG3667 for 4 weeks.

Group Type: EXPERIMENTAL

GLPG3667

Intervention Type: DRUG

GLPG3667 capsules

GLPG3667 Dose B

Daily doses of GLPG3667 for 4 weeks.

Group Type: EXPERIMENTAL

GLPG3667

Intervention Type: DRUG

GLPG3667 capsules

Placebo

Placebo to match will be administered as capsules for daily oral use.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo capsules

Interventions

GLPG3667

GLPG3667 capsules

Intervention Type: DRUG

Placebo

Matching placebo capsules

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects must be male or female between 18-64 years of age (extremes included), on the date of signing the informed consent form (ICF).
• Subject must be diagnosed (for at least 6 months before screening) of moderate to severe intensity plaque psoriasis. Subject's plaque psoriasis must be stable, defined as no flare during the month before the screening visit and no change of the severity between the screening visit and baseline visit.
• At screening and at baseline (Day 1, predose), PASI >=12 (moderate to severe) and plaque-type psoriasis covering at least 10% of total body surface area (BSA).
• At screening a Physician's Global Assessment (PGA ) score of 3 ("moderate") or 4 ("severe").
• Subject must be considered by dermatologist investigator to be a candidate for systemic therapy of plaque psoriasis (either naïve or history of previous systemic treatment).

Exclusion Criteria

• Subject has a known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator.
• Subjects with psoriasis other than plaque type or complicated psoriasis such as guttate, erythrodermic, exfoliative, inverse, pustular, palmo plantar, infected, or ulcerated psoriasis.
• Subject has evidence of skin conditions other than psoriasis (e.g. eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis.
• Subject is unable to discontinue prohibited therapies for the treatment of plaque psoriasis and/or cannot discontinue phototherapy (ultraviolet B (UVB) or psoralen and ultraviolet A (PUVA)) before the start of the study up to the end of the study.
• Subjects with current or a known or suspected history of immunosuppressive condition, history of invasive opportunistic infections (e.g. human immunodeficiency virus (HIV) infection, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis, or organ or bone marrow transplantation).
• Subjects having an active clinically significant infection or any infection requiring oral or systemic therapy within 2 weeks prior screening or subjects currently on any chronic oral or systemic antiinfective therapy for chronic infection.
• Subject testing positive for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection as detected at screening based on real time polymerase chain reaction (RT-PCR) or at baseline based on Immunoglobulin M (IgM) immunoassay, or subjects who have been in contact with SARS-CoV-2 infected individuals in the two weeks prior to first dosing of IP. Subjects presenting any signs or symptoms of SARS-Cov-2 infection as detected at screening or baseline following careful physical examination (e.g. cough, fever, headaches, fatigue, dyspnea, myalgia, anosmia, dysgeusia, anorexia, sore throat, etc.). In addition, any other locally applicable standard diagnostic criteria may also apply to diagnose SARS-CoV-2 infection.
• Subjects with evidence of active or latent infection with Mycobacterium tuberculosis (TB) as defined by:

1. Positive QuantiFERON-TB Gold test result, AND/OR

2. Chest radiograph (posterior anterior view) taken within 12 weeks prior to screening, read by a qualified radiologist or pulmonologist, with evidence of current active TB or old inactive TB.

• Subjects with a history of TB who have successful treatment documentation are eligible for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helen Timmis, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

MC Comac Medical Ltd.

Sofia, , Bulgaria

Early Clinical Trials Unit University Clinical Centre

Gdansk, , Poland

Barbara Rewerska Diamond Clinic Specjalistyczne Poradnie Lekarskie

Krakow, , Poland

Centrum Medyczne All-Med

Lodz, , Poland

Reumed Sp. z o. o.

Lublin, , Poland

WIP Warsaw IBD Point

Warsaw, , Poland

Summit Clinical Research, s.r.o.

Bratislava, , Slovakia

Countries

Bulgaria; Poland; Slovakia

Other Identifiers

2020-001427-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG3667-CL-112

Identifier Type: -

Identifier Source: org_study_id