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GLPG3970

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Lakefront Biotherapeutics|Last Updated: Sep 19, 2024

Target and mechanism

ModalitySmall molecule

Also known as GLPG3970 oral solution, GLPG3970 film-coated tablet, GLPG3970 film-coated, [14C]GLPG3970 solution for infusion, GLPG3970 for infusion, [14]GLPG3970 oral solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

GLPG3970 · 6 trials · 4 indications

Phase 2 2Phase 1 4
NCT04577781A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to MethotrexateRheumatoid Arthritis
COMPLETED28 Analytics
NCT04577794A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative ColitisUlcerative Colitis
COMPLETED31 Analytics
PHASE2COMPLETED
A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Rheumatoid Arthritis
NCT0457778128
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PHASE2COMPLETED
A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis
Ulcerative Colitis
NCT0457779431
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Study Endpoints

Primary Endpoints

Change From Baseline in DAS-28 (CRP) at Week 6
Baseline and 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. * TJC28 ranges from 0-28 * SJC28 ranges from 0-28 * High sensitivity C-reactive protein (hsCRP) (in mg/L) * Patient's disease activity VAS (in mm) (ranges from 0 = best to 100 = worst) 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.

Change From Baseline in Total MCS at Week 6
Baseline and Week 6

The MCS is the primary tool for assessing ulcerative colitis activity. Total MCS is the sum of 4 subscores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 (normal) to 3 (severe). The total MCS value ranges from 0 to 12, with higher scores indicating more severe disease. Missing data were imputed using Rubin's multiple imputation.

Absolute oral bioavailability (F [%]) of GLPG3970
From Day 1 pre-dose until Day 4 in Period 1
Recovery of total radioactivity excreted in urine expressed as a percentage of the administered dose (Ae%).
From Day 1 pre-dose until Day 8 in Period 2
Recovery of total radioactivity excreted in feces expressed as a percentage of the administered dose (Ae%).
From Day 1 pre-dose until Day 8 in Period 2
Maximum observed plasma concentration (Cmax) of GLPG3970
Between Day 1 pre-dose and Day 4

To assess the bioavailability (BA) of a GLPG3970 oral tablet formulation (test) relative to that of an oral solution formulation (reference). To assess the effect of food on BA of a single oral dose of the oral tablet formulation of GLPG3970.

Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
Between Day 1 pre-dose and Day 4

To assess the BA of a GLPG3970 oral tablet formulation (test) relative to that of an oral solution formulation (reference). To assess the effect of food on BA of a single oral dose of the oral tablet formulation of GLPG3970.

Area under the plasma concentration-time curve from time zero until the last observed quantifiable concentration (AUC0-t)
Between Day 1 pre-dose and Day 4

To assess the BA of a GLPG3970 oral tablet formulation (test) relative to that of an oral solution formulation (reference). To assess the effect of food on BA of a single oral dose of the oral tablet formulation of GLPG3970.

Maximum observed concentration (Cmax) of sulfasalazine
Between Day 1 pre-dose and Day 12

To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.

Cmax of sulfapyridine
Between Day 1 pre-dose and Day 12

To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.

Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of sulfasalazine
Between Day 1 pre-dose and Day 12

To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.

AUC0-inf of sulfapyridine
Between Day 1 pre-dose and Day 12

To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.

Sulfapyridine to sulfasalazine AUC ratio
Between Day 1 pre-dose and Day 12

To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.

Number of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
From screening through study completion, an average of 20 months

To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult healthy male subjects as single and multiple ascending oral doses, and in subjects with moderate to severe psoriasis when administered daily for 6 weeks

Secondary Endpoints

Number of Participants With Treatment Emergent Adverse Events
From first dose of study drug until end of the study (up to 8 weeks)
Plasma Concentration (Ctrough) of GLPG3970
Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
First dose date up to 14 days after the last dose of study drug (up to 57 days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GLPG3970EXPERIMENTALParticipants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.
PlaceboPLACEBO_COMPARATORParticipants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
Absolute Bioavailability - Period 1EXPERIMENTALParticipants will receive GLPG3970 under fasted conditions followed by an intravenous (i.v.) microtracer microdose of \[14C\]GLPG3970 on Day 1.
Mass Balance - Period 2EXPERIMENTALParticipants will receive \[14C\]GLPG397 under fasted conditions on Day 1.
GLPG3970 solutionEXPERIMENTALSingle oral dose of GLPG3970 in fasted conditions
GLPG3970 tablet fastedEXPERIMENTALSingle oral dose of GLPG3970 in fasted conditions
GLPG3970 tablet fedEXPERIMENTALSingle oral dose of GLPG3970 in fed conditions
Sulfasalazine + GLPG3970EXPERIMENTAL -
GLPG3970 SADEXPERIMENTALSingle doses of GLPG3970 at up to 6 dose levels in ascending order
Placebo SADPLACEBO_COMPARATORSingle doses of placebo
GLPG3970 MADEXPERIMENTALMultiple doses of GLPG3970 at up to 4 dose levels in ascending order, daily for 14 days
Placebo MADPLACEBO_COMPARATORMultiple doses of placebo
GLPG3970 FE-rBAEXPERIMENTALSingle dose of GLPG3970 in fed and fasted state
GLPG3970 FEEXPERIMENTALSingle dose of GLPG3970 in fed and fasted state
GLPG3970 in psoriasis subjectsEXPERIMENTAL -
Placebo in psoriasis subjectsEXPERIMENTAL -

Interventions

NameTypeDescription
GLPG3970DRUGGLPG3970 powder and solvent for oral solution to be reconstituted prior to use.
PlaceboDRUGPlacebo powder and solvent for oral solution to be reconstituted prior to use.
GLPG3970 film-coated tabletDRUGParticipants will receive a single oral dose of GLPG3970.
[14C]GLPG3970 solution for infusionDRUGParticipants will receive an i.v. microtracer microdose.
[14]GLPG3970 oral solutionDRUGParticipants will receive a single oral dose \[14C\]GLPG3970.
GLPG3970 oral solutionDRUGGLPG3970 for oral administration
GLPG3970 tabletDRUGGLPG3970 for oral administration
SulfasalazineDRUGOn Day 1, Day 5 and Day 9, a single oral dose of sulfasalazine tablets in fasted state.
Placebo oral solutionDRUGPlacebo for oral administration
GLPG3970 capsuleDRUGGLPG3970 for oral administration
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites9

Key Inclusion Criteria: 1. A body mass index (BMI) between 18-32 kg/m\^2, inclusive. 2. Diagnosis of RA ≥6 months prior to screening AND meeting the 2010 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) criteria of RA AND ACR functional class I-III. 3. Have ≥6 swol...

Countries:BulgariaGeorgiaPolandUkraineMoldovaUnited KingdomFranceUnited StatesBelgium
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Competitive Landscape -Rheumatoid Arthritis 91 trials

Top 20 of 27 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV5PHASE3Adalimumab, Upadacitinib, Lutikizumab, Ravagalimab
Bristol-Myers Squibb CompanyBMY6PHASE3Abatacept, Zolacabtagene autoleucel, BMS-986528, BMS-986454
Eli Lilly and CompanyLLY4PHASE3Baricitinib, LY4213663, LY4298445
Johnson & JohnsonJNJ1PHASE3Guselkumab
AstraZeneca PLCAZN4PHASE2AZD1163, AZD0120, AZD5492, Surovatamig
Novartis AG Sponsored ADRNVS3PHASE2Ianalumab, PIT565, Secukinumab
Merck & Co., Inc.MRK2PHASE2Tulisokibart, MK-1045
AnaptysBio, Inc.ANAB1PHASE2Rosnilimab
Spyre Therapeutics, IncSYRE1PHASE2SPY002-072
Sanofi SA Sponsored ADRSNY2PHASE2Sarilumab, SAR448501
Immunovant IncIMVT1PHASE2IMVT-1402
XBiotech, Inc.XBIT1PHASE2Natrunix
Amgen Inc.AMGN1PHASE2Inebilizumab, Blinatumomab
Artiva Biotherapeutics, Inc.ARTV2PHASE2AB-101
Gilead Sciences, Inc.GILD1PHASE1GS-0151
Cullinan Therapeutics, Inc.CGEM1PHASE1CLN-978
Xencor, Inc.XNCR1PHASE1Plamotamab
Adicet Bio IncACET1PHASE1ADI-001
Pfizer Inc.PFE2 - tofacitinib
Jade Biosciences, Inc.JBIO1PHASE1JADE201
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