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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 64 Years
Gender All
More Inclusion & Exclusion 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).
This list only contains the key inclusion criteria.

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.
This list only contains the key exclusion criteria.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04594928
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Galapagos NV
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Helen Timmis, MD
Principal Investigator Affiliation Galapagos NV
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Bulgaria, Poland, Slovakia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Arms & Interventions

Arms

Experimental: GLPG3667 Dose A

Daily doses of GLPG3667 for 4 weeks.

Experimental: GLPG3667 Dose B

Daily doses of GLPG3667 for 4 weeks.

Placebo Comparator: Placebo

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

Interventions

Drug: - GLPG3667

GLPG3667 capsules

Drug: - Placebo

Matching placebo capsules

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

MC Comac Medical Ltd., Sofia, Bulgaria

Status

Recruiting

Address

MC Comac Medical Ltd.

Sofia, , 1612

Gdańsk, Poland

Status

Recruiting

Address

Early Clinical Trials Unit University Clinical Centre

Gdańsk, , 80-214

Kraków, Poland

Status

Recruiting

Address

Barbara Rewerska Diamond Clinic Specjalistyczne Poradnie Lekarskie

Kraków, , 31-559

Reumed Sp. z o. o., Lublin, Poland

Status

Recruiting

Address

Reumed Sp. z o. o.

Lublin, , 20-607

WIP Warsaw IBD Point, Warsaw, Poland

Status

Recruiting

Address

WIP Warsaw IBD Point

Warsaw, , 00-728

Centrum Medyczne All-Med, Łódź, Poland

Status

Recruiting

Address

Centrum Medyczne All-Med

Łódź, , 94-048

Summit Clinical Research, s.r.o., Bratislava, Slovakia

Status

Recruiting

Address

Summit Clinical Research, s.r.o.

Bratislava, , 831 01

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