Plaque PsoriasisPhase 1NCT04594928
A Study Evaluating the Effects of GLPG3667 Given as an Oral Treatment for 4 Weeks in Adults With Moderate to Severe Plaque Psoriasis
A Phase 1 study testing GLPG3667 in people with Plaque Psoriasis, run by Lakefront Biotherapeutics NV at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- GLPG3667
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 19 Oct 2020to 4 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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:
- Positive QuantiFERON-TB Gold test result, AND/OR
- 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 locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Poland5 sites
Early Clinical Trials Unit University Clinical Centre
Gdansk, 80-214
Barbara Rewerska Diamond Clinic Specjalistyczne Poradnie Lekarskie
Krakow, 31-559
Centrum Medyczne All-Med
Lodz, 94-048
Reumed Sp. z o. o.
Lublin, 20-607
WIP Warsaw IBD Point
Warsaw, 00-728
About this study
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
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
- Being tested
- GLPG3667, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG3667Drug
GLPG3667 capsules
PlaceboDrug
Matching placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| GLPG3667 Dose A | Experimental | Daily doses of GLPG3667 for 4 weeks. Receives: Drug: GLPG3667 |
| GLPG3667 Dose B | Experimental | Daily doses of GLPG3667 for 4 weeks. Receives: Drug: GLPG3667 |
| Placebo | Placebo comparator | Placebo to match will be administered as capsules for daily oral use. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From screening through study completion, an average of 3 months
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.
Measured: At week 4
Secondary outcomes (2)
Observed GLPG3667 plasma trough concentrations (Ctrough).
To characterize the pharmacokinetics (PK) of GLPG3667 in subjects with moderate to severe plaque psoriasis.
Measured: Between Day 1 pre-dose and Day 30
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.
Measured: Between Day 1 pre-dose and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start19 Oct 2020
- Primary completion4 May 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helen Timmis, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594928
- Sponsor's protocol ID
- GLPG3667-CL-112
- Other IDs
- 2020-001427-14
- Status last verified
- May 2021
- First submitted
- 5 Oct 2020
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04594928
- Acronym / sponsor ID
- GLPG3667-CL-112
- Conditions
- Plaque Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GLPG3667 Dose A | Experimental | Drug: GLPG3667Daily doses of GLPG3667 for 4 weeks. |
| GLPG3667 Dose B | Experimental | Drug: GLPG3667Daily doses of GLPG3667 for 4 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to match will be administered as capsules for daily oral use. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLPG3667GLPG3667 capsules | Drug | GLPG3667 Dose A, GLPG3667 Dose B |
| PlaceboMatching placebo capsules | Drug | Placebo |
Primary outcome
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.
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.
2 secondary outcomes
Observed GLPG3667 plasma trough concentrations (Ctrough).
Time frame: Between Day 1 pre-dose and Day 30
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Timmis, MD study director
Lakefront Biotherapeutics NV
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLPG3667 in people with Plaque Psoriasis, run by Lakefront Biotherapeutics NV at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Poland, Bulgaria, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.