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

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ClinicalTrials.gov Identifier: NCT04594928
Recruitment Status : Completed
First Posted : October 20, 2020
Last Update Posted : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: GLPG3667 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of GLPG3667 in Subjects With Moderate to Severe Plaque Psoriasis
Actual Study Start Date : October 19, 2020
Actual Primary Completion Date : May 4, 2021
Actual Study Completion Date : May 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: GLPG3667 Dose A
Daily doses of GLPG3667 for 4 weeks.
Drug: GLPG3667
GLPG3667 capsules

Experimental: GLPG3667 Dose B
Daily doses of GLPG3667 for 4 weeks.
Drug: GLPG3667
GLPG3667 capsules

Placebo Comparator: Placebo
Placebo to match will be administered as capsules for daily oral use.
Drug: Placebo
Matching placebo capsules




Primary Outcome Measures :
  1. Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation in subjects with moderate to severe plaque psoriasis. [ Time Frame: From screening through study completion, an average of 3 months ]
    To evaluate the safety and tolerability of GLPG3667 compared to placebo in subjects with moderate to severe plaque psoriasis.

  2. Psoriasis Area and Severity Index (PASI) % change [ Time Frame: At week 4 ]
    To evaluate signs of clinical efficacy of GLPG3667 compared to placebo in subjects with moderate to severe plaque psoriasis.


Secondary Outcome Measures :
  1. Observed GLPG3667 plasma trough concentrations (Ctrough). [ Time Frame: Between Day 1 pre-dose and Day 30 ]
    To characterize the pharmacokinetics (PK) of GLPG3667 in subjects with moderate to severe plaque psoriasis.

  2. Change from baseline in interleukin 17 [IL-17] levels between treatment groups and time points. [ Time Frame: Between Day 1 pre-dose and Day 60 ]
    To evaluate blood pharmacodynamics (PD) markers in response to administration of GLPG3667 in subjects with moderate to severe plaque psoriasis.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04594928


Locations
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Bulgaria
MC Comac Medical Ltd.
Sofia, Bulgaria, 1612
Poland
Early Clinical Trials Unit University Clinical Centre
Gdańsk, Poland, 80-214
Barbara Rewerska Diamond Clinic Specjalistyczne Poradnie Lekarskie
Kraków, Poland, 31-559
Reumed Sp. z o. o.
Lublin, Poland, 20-607
WIP Warsaw IBD Point
Warsaw, Poland, 00-728
Centrum Medyczne All-Med
Łódź, Poland, 94-048
Slovakia
Summit Clinical Research, s.r.o.
Bratislava, Slovakia, 831 01
Sponsors and Collaborators
Galapagos NV
Investigators
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Study Director: Helen Timmis, MD Galapagos NV
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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT04594928    
Other Study ID Numbers: GLPG3667-CL-112
2020-001427-14 ( EudraCT Number )
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases