Systemic Lupus ErythematosusPhase 1TAPINOMANCT04700267
A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus Erythematosus
A Phase 1 study testing GLPG3970 film-coated tablet in people with Systemic Lupus Erythematosus, run by Lakefront Biotherapeutics NV at 14 sites in 5 countries.
Trial summary
This is a first exploration of GLPG3970 in subjects with active systemic lupus erythematosus (SLE) to evaluate the effect on disease biomarkers and to determine its pharmacokinetics (PK) profile, safety and tolerability, and pharmacodynamics (PD) biomarkers related to the investigational product (IP) mechanism of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- GLPG3970 film-coated tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 28 Dec 2020to 6 Oct 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SLE diagnosis defined by American College of Rheumatology (ACR) 1997 criteria ≥4
- Active arthritis in >=4 active joints (according to 28 joint count) and/or cutaneous lupus erythematosus disease area and severity index (CLASI) score >=6.
- Anti-dsDNA antibodies >15 IU/mL.
- Stable standard-of-care (SoC) therapy (defined as no change in prescription for at least 2 weeks prior to first IP dosing) consisting of the following permitted SoC medications:
- Corticosteroids <=20 mg/day (prednisone or equivalent) for at least 2 weeks prior to first IP dosing; AND/OR
- Non-steroidal anti-inflammatory drug (NSAIDs); AND/OR
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- One single antimalarial at a stable dose (hydroxychloroquine <=5 mg/ kg/day, quinacrine 100 mg/day, or chloroquine 2.3 mg/kg/day) for at least 8 weeks prior to first IP dosing; AND/OR
- One single immunosuppressant at a stable dose (azathioprine (AZA) <=2 mg/kg/day, methotrexate (MTX) <=20 mg/week, or mycophenolate mofetil (MMF) <=2 g/day) for at least 8 weeks prior to first IP dosing.
- estimated glomerular filtration rate (eGFR) >=60 mL/min (according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI))
- This list only contains the key inclusion criteria.
Who cannot join
- Lupus nephritis >= Class III
- Severe organ manifestation or life-threatening lupus disease (active severe central nervous system lupus, severe pleuro-pericarditis, severe vasculitis).
- Severe acute respiratory syndrome coronavirus disease 2 (SARS-CoV-2) infection >0
- Unstable condition not related to SLE
- Systemic inflammatory condition other than SLE such as, but not limited to rheumatoid arthritis (RA), spondyloarthropathy, Crohn's disease, ulcerative colitis, or psoriatic arthritis
- Sjögren's syndrome and/or antiphospholipid antibody syndrome who do not require treatment with any prohibited medication are NOT excluded.
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- Active systemic infection
- Poorly controlled chronic cardiac, pulmonary, or renal disease.
- Known or suspected history of or a current immunosuppressive condition, or a history of invasive opportunistic infections
- Treatment with disallowed therapies
- This list only contains the key exclusion criteria.
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
Ukraine5 sites
Medical Centre of Ltd Liability Comp
Kyiv, 01135
Multidisciplinary Medical Center of Odesa National Medical University
Odesa, 65026
N.I.Pirogov Vinnytsia Reg Council
Vinnytsia, 21028
SRI of Invalid Rehabilitation
Vinnytsia, 21029
LLC Suchasna klinika
Zaporizhzhya, 69600
Poland4 sites
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, 85168
Centrum Medyczne Plejady
Krakow, 30363
Medycyna Kliniczna
Warsaw, 00874
FutureMeds sp. Z o. o.
Wroclaw, 50088
Bulgaria3 sites
Medical center Medconsult Pleven
Pleven, 5800
UMHAT-Plovdiv AD
Plovdiv, 4002
UMHAT Sv. Ivan Rilski EAD
Sofia, 1612
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Systemic Lupus Erythematosus
This is a first exploration of GLPG3970 in subjects with active systemic lupus erythematosus (SLE) to evaluate the effect on disease biomarkers and to determine its pharmacokinetics (PK) profile, safety and tolerability, and pharmacodynamics (PD) biomarkers related to the investigational product (IP) mechanism of action and the pathophysiology of SLE.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- GLPG3970 film-coated tablet, Placebo film-coated tablet
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG3970 film-coated tabletDrug
GLPG3970 for oral administration
Placebo film-coated tabletDrug
Placebo for oral administration
| Study group | Role | What they receive |
|---|---|---|
| GLPG3970 | Experimental | One dose level of GLPG3970 Receives: Drug: GLPG3970 film-coated tablet |
| Placebo | Placebo comparator | One dose level of Placebo Receives: Drug: Placebo film-coated tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biomarkers associated with disease anti-dsDNA
To characterize the PD of GLPG3970 compared to placebo in adult subjects with active SLE
Measured: Between Day 1 and 104
Change in biomarkers associated with disease complement component 3 (C3), and complement component 4 (C4)
To characterize the PD of GLPG3970 compared to placebo in adult subjects with active SLE
Measured: Between Day 1 and 104
Number, incidence, and severity of treatment-emergent adverse events (TEAEs)
To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult subjects with active SLE
Measured: From screening through study completion, an average of 5 months
Secondary outcomes (1)
Observed GLPG3970 plasma trough concentrations (Ctrough)
To characterize the PK of GLPG3970 in adult subjects with active SLE
Measured: Between Day 1 and 87
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start28 Dec 2020
- Primary completion6 Oct 2021
- Study completion6 Oct 2021
Why it stopped: Study stopped on business grounds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catherine Vincent, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700267
- Sponsor's protocol ID
- GLPG3970-CL-102
- Other IDs
- 2020-001820-32
- Acronym
- TAPINOMA
- Status last verified
- Oct 2021
- First submitted
- 6 Jan 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT04700267
- Acronym / sponsor ID
- TAPINOMA / GLPG3970-CL-102
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped on business grounds
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 7 Jan 2021 (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.
This is a first exploration of GLPG3970 in subjects with active systemic lupus erythematosus (SLE) to evaluate the effect on disease biomarkers and to determine its pharmacokinetics (PK) profile, safety and tolerability, and pharmacodynamics (PD) biomarkers related to the investigational product (IP) mechanism of action and the pathophysiology of SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLPG3970 | Experimental | Drug: GLPG3970 film-coated tabletOne dose level of GLPG3970 |
| Placebo | Placebo comparator | Drug: Placebo film-coated tabletOne dose level of Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- SLE diagnosis defined by American College of Rheumatology (ACR) 1997 criteria ≥4
- Active arthritis in >=4 active joints (according to 28 joint count) and/or cutaneous lupus erythematosus disease area and severity index (CLASI) score >=6.
- Anti-dsDNA antibodies >15 IU/mL.
- Stable standard-of-care (SoC) therapy (defined as no change in prescription for at least 2 weeks prior to first IP dosing) consisting of the following permitted SoC medications:
- estimated glomerular filtration rate (eGFR) >=60 mL/min (according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI))
Key exclusion criteria (11 listed)
- Lupus nephritis >= Class III
- Severe organ manifestation or life-threatening lupus disease (active severe central nervous system lupus, severe pleuro-pericarditis, severe vasculitis).
- Severe acute respiratory syndrome coronavirus disease 2 (SARS-CoV-2) infection >0
- Unstable condition not related to SLE
- Systemic inflammatory condition other than SLE such as, but not limited to rheumatoid arthritis (RA), spondyloarthropathy, Crohn's disease, ulcerative colitis, or psoriatic arthritis
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 |
|---|---|---|
| GLPG3970 film-coated tabletGLPG3970 for oral administration | Drug | GLPG3970 |
| Placebo film-coated tabletPlacebo for oral administration | Drug | Placebo |
Primary outcome
Change in biomarkers associated with disease anti-dsDNA
Time frame: Between Day 1 and 104
To characterize the PD of GLPG3970 compared to placebo in adult subjects with active SLE
Change in biomarkers associated with disease complement component 3 (C3), and complement component 4 (C4)
Time frame: Between Day 1 and 104
To characterize the PD of GLPG3970 compared to placebo in adult subjects with active SLE
Number, incidence, and severity of treatment-emergent adverse events (TEAEs)
Time frame: From screening through study completion, an average of 5 months
To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult subjects with active SLE
1 secondary outcome
Observed GLPG3970 plasma trough concentrations (Ctrough)
Time frame: Between Day 1 and 87
Results and safety
The study was stopped early (reason given: Study stopped on business grounds). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 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.
Catherine Vincent, MD study director
Lakefront Biotherapeutics NV
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLPG3970 film-coated tablet in people with Systemic Lupus Erythematosus, run by Lakefront Biotherapeutics NV at 14 sites in 5 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 10 inclusion and 11 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: stopped early, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Ukraine, Poland, Bulgaria, Moldova, Spain. 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 was stopped early (reason given: Study stopped on business grounds). Results are not available in the source record.
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?
Change in biomarkers associated with disease anti-dsDNA (time frame: Between Day 1 and 104). The study lists 3 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 21 Oct 2021.