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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000658-83 | EudraCT Number |
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The primary objective of this study was to evaluate the effect of GLPG3970 compared to placebo on the signs and symptoms of Rheumatoid Arthritis (RA) in participants with moderately to severely active RA and an inadequate response to methotrexate (MTX).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG3970 | Experimental | Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks. |
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| Placebo | Placebo Comparator | Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG3970 | Drug | GLPG3970 powder and solvent for oral solution to be reconstituted prior to use. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in DAS-28 (CRP) at Week 6 | The DAS28 (CRP) is a derived measurement with differential weighting given to each component such as TJC28, SJC28, patient's global assessment of disease activity, and serum CRP level.
The DAS28 (CRP) score was calculated using the below formula: DAS28 (CRP) = 0.56 x square root of TJC28 + 0.28 x square root of SJC28 + 0.36 x Ln[1+CRP(in mg/L)] + 0.014 x patient's disease activity VAS (in mm) + 0.96. A lower score is considered as better disease activity. | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | Treatment-Emergent Adverse Events (TEAE) were defined as
Serious TEAE was defined as a TEAE that
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Key Inclusion Criteria:
Key Exclusion Criteria:
Current therapy with any conventional disease-modifying antirheumatic drug (DMARD) other than MTX, including
Current or previous treatment with a biologic DMARD (bDMARD). Except for participants who received bDMARDs only in a single clinical study setting:
Participants who received an intra-articular or parenteral corticosteroid injection within 4 weeks prior to screening.
Participants who received a prior surgical intervention within 12 weeks prior to screening or likely requirement for surgery during the study.
Participant has a history of tuberculosis (TB) diagnosis or evidence of active or latent infection with Mycobacterium tuberculosis as defined by one of the following assessments:
Participant has any active systemic infection within the last 2 weeks prior to first IP dosing, or poorly controlled chronic cardiac, pulmonary or renal disease.
Participant has a known or suspected history of or a current immunosuppressive condition, or a history of invasive opportunistic infections (e.g. human immunodeficiency virus [HIV] infection, histoplasmosis, listeriosis, coccidiodmycosis, pneumocystosis, aspergillosis).
Participant has a chronic hepatitis B virus (HBV) infection, as defined by persistent HBV surface antigen (HBsAg) positivity. Participant has hepatitis C virus (HCV) infection, as defined by positive HCV antibody at screening and detectable HCV viremia. Participants with positive HCV antibody must undergo reflex HCV ribonucleic acid (RNA) testing, and participants with HCV RNA positivity will be excluded. Participants with positive HCV antibody and negative HCV RNA are eligible.
Participant testing positive at screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as detected by real time polymerase chain reaction (RT-PCR), participants presenting any signs or symptoms as detected at baseline following careful physical examination (e.g. cough, fever, headaches, fatigue, dyspnea, myalgia, anosmia, dysgeusia, anorexia, sore throat, others) or reporting any signs and symptoms for the 2 preceding weeks, or participants who have been exposed to individuals with confirmed or suspected diagnosis of SARS-CoV-2 within 2 weeks prior to baseline. In addition, any other locally applicable standard diagnostic criteria may also apply to rule out SARS-CoV-2 infection.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Galapagos Medical Director | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center Teodora | Rousse | 7000 | Bulgaria | |||
| UMHAT Sv. Ivan Rilski EAD |
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Participants remained on a stable dose (10 to 20 mg/week) of MTX as background medication.
Study was conducted across 4 countries (Georgia, Poland, Bulgaria, and Ukraine). A total of 54 participants were screened, out of which 28 were randomized and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | GLPG3970 | Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks. |
| FG001 | Placebo | Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 29, 2020 | Jan 27, 2022 |
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| Placebo |
| Drug |
Placebo powder and solvent for oral solution to be reconstituted prior to use. |
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| From first dose of study drug until end of the study (up to 8 weeks) |
| Plasma Concentration (Ctrough) of GLPG3970 | Ctrough was defined as plasma concentration level at the end of the dosing interval. | Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose |
| Sofia |
| 1431 |
| Bulgaria |
| Aversi Clinic Ltd | Tbilisi | 0160 | Georgia |
| Consilium Medulla-multiprofile clinic Ltd | Tbilisi | 0186 | Georgia |
| Centrum Medyczne Grunwald | Poznan | 60-369 | Poland |
| Centrum Badan Klinicznych S.C. | Poznan | 60-773 | Poland |
| GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine | Kharkiv | 61039 | Ukraine |
| SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU | Vinnytsia | 21029 | Ukraine |
| Medical Center Clinic of Modern Rheumatology | Zaporizhzhya | 69005 | Ukraine |
| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set (SAS) consisted of all participants who received at least 1 dose of investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | GLPG3970 | Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks. |
| BG001 | Placebo | Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Disease Activity Score Based on 28 Joints C-reactive Protein [DAS28 (CRP)] | The DAS28 (CRP) is a derived measurement with differential weighting given to each component such as Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), patient's global assessment of disease activity, and serum CRP level. DAS28 (CRP) = 0.56 x square root of TJC28 + 0.28 x square root of SJC28 + 0.36 x Ln[1+CRP(in mg/L)] + 0.014 x patient's disease activity VAS (in mm) + 0.96. A lower score is considered as better disease activity. | Mean | Standard Deviation | Score on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in DAS-28 (CRP) at Week 6 | The DAS28 (CRP) is a derived measurement with differential weighting given to each component such as TJC28, SJC28, patient's global assessment of disease activity, and serum CRP level.
The DAS28 (CRP) score was calculated using the below formula: DAS28 (CRP) = 0.56 x square root of TJC28 + 0.28 x square root of SJC28 + 0.36 x Ln[1+CRP(in mg/L)] + 0.014 x patient's disease activity VAS (in mm) + 0.96. A lower score is considered as better disease activity. | Full analysis set (FAS) consisted of all randomized participants who had been administered at least 1 dose of investigational product. Participants with available data at specified timepoint were included. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline and Week 6 |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events | Treatment-Emergent Adverse Events (TEAE) were defined as
Serious TEAE was defined as a TEAE that
| Participants in the safety analysis set | Posted | Number | Participants | From first dose of study drug until end of the study (up to 8 weeks) |
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| Secondary | Plasma Concentration (Ctrough) of GLPG3970 | Ctrough was defined as plasma concentration level at the end of the dosing interval. | Pharmacokinetic analysis set (PKAS) consisted all participants who received at least 1 dose of investigational product with available plasma concentration data. Participants with available plasma concentration at specified time point were included. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose |
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From first dose of study drug until end of the study (up to 8 weeks)
Safety analysis set
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GLPG3970 | Participants received 400 mg GLPG3970 oral solution, QD for a period 6 weeks. | 0 | 16 | 0 | 16 | 6 | 16 |
| EG001 | Placebo | Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks. | 0 | 12 | 0 | 12 | 2 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA (23.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Galapagos Medical Information | Galapagos NV | +32 15 342 900 | medicalinfo@glpg.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 7, 2021 | Jan 27, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
| D007592 | Joint Diseases |
| D001327 | Autoimmune Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
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| Participants |
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