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History of Changes for Study: NCT04594928
A Study Evaluating the Effects of GLPG3667 Given as an Oral Treatment for 4 Weeks in Adults With Moderate to Severe Plaque Psoriasis
Latest version (submitted February 19, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 14, 2020 None (earliest Version on record)
2 October 20, 2020 Study Status
3 November 10, 2020 Study Status, Contacts/Locations and Eligibility
4 December 8, 2020 Study Status and Contacts/Locations
5 January 4, 2021 Study Status and Contacts/Locations
6 February 19, 2021 Study Status and Contacts/Locations
Comparison Format:

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Changes (Side-by-Side) for Study: NCT04594928
December 8, 2020 (v4) -- January 4, 2021 (v5)

Changes in: Study Status and Contacts/Locations

Study Identification
Unique Protocol ID: GLPG3667-CL-112 GLPG3667-CL-112
Brief Title: A Study Evaluating the Effects of GLPG3667 Given as an Oral Treatment for 4 Weeks in Adults With Moderate to Severe Plaque Psoriasis A Study Evaluating the Effects of GLPG3667 Given as an Oral Treatment for 4 Weeks in Adults With Moderate to Severe Plaque Psoriasis
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 A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of GLPG3667 in Subjects With Moderate to Severe Plaque Psoriasis
Secondary IDs: 2020-001427-14 [EudraCT Number]2020-001427-14 [EudraCT Number]
Study Status
Record Verification: December 2020 January 2021
Overall Status: Recruiting Recruiting
Study Start: October 19, 2020 October 19, 2020
Primary Completion: March 2021 [Anticipated ] March 2021 [Anticipated ]
Study Completion: March 2021 [Anticipated ] March 2021 [Anticipated ]
First Submitted: October 5, 2020 October 5, 2020
First Submitted that
Met QC Criteria:
October 14, 2020 October 14, 2020
First Posted: October 20, 2020 [Actual ] October 20, 2020 [Actual ]
Last Update Submitted that
Met QC Criteria:
December 8, 2020 January 4, 2021
Last Update Posted: December 9, 2020 [Actual ] January 5, 2021 [Actual ]
Sponsor/Collaborators
Sponsor: Galapagos NV Galapagos NV
Responsible Party: Sponsor Sponsor
Collaborators:
Oversight
U.S. FDA-regulated Drug: No No
U.S. FDA-regulated Device: No No
Data Monitoring: No No
Study Description
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. 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.
Detailed Description:
Conditions
Conditions: Plaque Psoriasis Plaque Psoriasis
Keywords:
Study Design
Study Type: InterventionalInterventional
Primary Purpose: Basic ScienceBasic Science
Study Phase: Phase 1Phase 1
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 33
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: RandomizedRandomized
Enrollment: 30 [Anticipated ] 30 [Anticipated ]
Arms and Interventions
Arms Assigned Interventions
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
Outcome Measures
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.
To evaluate the safety and tolerability of GLPG3667 compared to placebo in subjects with moderate to severe plaque psoriasis.

[Time Frame: From screening through study completion, an average of 3 months ]
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.
To evaluate the safety and tolerability of GLPG3667 compared to placebo in subjects with moderate to severe plaque psoriasis.

[Time Frame: From screening through study completion, an average of 3 months ]
2. Psoriasis Area and Severity Index (PASI) % change
To evaluate signs of clinical efficacy of GLPG3667 compared to placebo in subjects with moderate to severe plaque psoriasis.

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

[Time Frame: At week 4 ]
Secondary Outcome Measures:
3. Observed GLPG3667 plasma trough concentrations (Ctrough).
To characterize the pharmacokinetics (PK) of GLPG3667 in subjects with moderate to severe plaque psoriasis.

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

[Time Frame: Between Day 1 pre-dose and Day 30 ]
4. Change from baseline in interleukin 17 [IL-17] levels between treatment groups and time points.
To evaluate blood pharmacodynamics (PD) markers in response to administration of GLPG3667 in subjects with moderate to severe plaque psoriasis.

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

[Time Frame: Between Day 1 pre-dose and Day 60 ]
Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age: 64 Years 64 Years
Sex: All All
Gender Based:
Accepts Healthy Volunteers: NoNo
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.

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.

Contacts/Locations
Central Contact: Galapagos Medical Information
Telephone: +32 15 34 29 00
Email: medicalinfo@glpg.com
Galapagos Medical Information
Telephone: +32 15 34 29 00
Email: medicalinfo@glpg.com
Study Officials: Judit Molnar, MD
Study Director
Galapagos NV
Judit Molnar, MD
Study Director
Galapagos NV
Locations: BulgariaBulgaria
MC Comac Medical Ltd.
[Recruiting]
Sofia, Bulgaria, 1612
MC Comac Medical Ltd.
[Recruiting]
Sofia, Bulgaria, 1612
Poland
Early Clinical Trials Unit University Clinical Centre
[Recruiting]
Gdańsk, Poland, 80-214
Poland
Reumed Sp. z o. o.
[Recruiting]
Lublin, Poland, 20-607
Reumed Sp. z o. o.
[Recruiting]
Lublin, Poland, 20-607
WIP Warsaw IBD Point
[Recruiting]
Warsaw, Poland, 00-728
WIP Warsaw IBD Point
[Recruiting]
Warsaw, Poland, 00-728
Centrum Medyczne All-Med
[Recruiting]
Łódź, Poland, 94-048
Centrum Medyczne All-Med
[Recruiting]
Łódź, Poland, 94-048
SlovakiaSlovakia
Summit Clinical Research, s.r.o.
[Recruiting]
Bratislava, Slovakia, 831 01
Summit Clinical Research, s.r.o.
[Recruiting]
Bratislava, Slovakia, 831 01
IPDSharing
Plan to Share IPD: No No
References
Citations:
Links:
Available IPD/Information:

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