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GLPG1205

Phase 2

Idiopathic Pulmonary Fibrosis | Small molecule | Respiratory |Lakefront Biotherapeutics|Trials Updated: Sep 14, 2021

GLPG1205 development status

Highest phase Phase 2
Registered trials 5 across 1 sponsor since Jun 2013

GLPG1205 target and mechanism

Molecular targetGPR84
Target classNegative Allosteric Modulator
ModalitySmall molecule

Also known as GLPG1205 single ascending doses, GLPG1205 film-coated tablets, GLPG1205 film-coated, [14C]-GLPG1205 solution for infusion, GLPG1205 for infusion, GLPG1205 capsules, GLPG1205 q.d

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment132

FDA Designations

No designations recorded

GLPG1205 clinical trials

GLPG1205 · 2 trials · 2 indications

Phase 2 2
NCT03725852A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis
COMPLETED68 Analytics
NCT02337608Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative ColitisUlcerative Colitis
COMPLETED64 Analytics
PHASE2COMPLETED
A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary FibrosisUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis
Ulcerative ColitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Forced Vital Capacity (FVC) at Week 26
Baseline, Week 26

Forced vital capacity (FVC) (in milliliter \[mL\]) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

Changes in Mayo score at Week 8
Screening and Week 8

To evaluate the efficacy of GLPG1205 in terms of changes in Mayo score comparing results at Week 8 with baseline between GLPG1205 treated subjects and placebo subjects

Secondary Endpoints

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation
First dose date up to 30 days after the last dose of study drug (maximum up to 263 days)
Time to Any Major Events Depicted by Cumulative Percentage of Participants With All-cause Deaths, Respiratory-related Deaths, All-cause Hospitalizations, and Respiratory-related Hospitalizations
Day 1 up to Week 30
Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26
Baseline, Week 26
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GLPG1205 100 mgEXPERIMENTALParticipants will receive GLPG1205 100 milligrams (mg) (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care includes nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
PlaceboPLACEBO_COMPARATORParticipants will receive GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care includes nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
GLPG1205 100mg QDEXPERIMENTALGLPG1205 100mg daily dosing in the morning

Interventions

NameTypeDescription
GLPG1205DRUGGLPG1205 will be provided as an oral hard gelatin capsule.
PlaceboDRUGGLPG1205 matching placebo will be provided as an oral hard gelatin capsule.
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion criteria: Participants who meet all of the following criteria are eligible for the study: * A diagnosis of IPF within 5 years prior to the screening visit as per applicable American Thoracic Society (ATS)/European Respiratory Society(ERS)/Japanese Respiratory Society (JRS)/Latin American...

Countries:BulgariaCroatiaFinlandFranceOmanRomaniaSlovakiaSwedenUkraineBelgiumCzechiaGermanyHungaryPolandRussia
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Frequently asked questions about GLPG1205

What is GLPG1205 used for?

GLPG1205 is an investigational small molecule being studied for idiopathic pulmonary fibrosis and ulcerative colitis. It has been evaluated in Phase 2 clinical trials for both conditions. It is not approved for any indication and remains in clinical development.

What does GLPG1205 target?

GLPG1205 targets GPR84, a G protein-coupled receptor. It acts as a negative allosteric modulator of GPR84, meaning it binds to a site distinct from the receptor's natural ligand and reduces receptor signaling rather than blocking the ligand binding site directly.

Who is developing GLPG1205?

GLPG1205 is being developed by Lakefront Biotherapeutics, which trades under the ticker LKFT. The company is the sponsor of the clinical trials evaluating GLPG1205 in idiopathic pulmonary fibrosis and ulcerative colitis.

What phase is GLPG1205 in?

GLPG1205 is in Phase 2 clinical development. It has completed Phase 2 trials in idiopathic pulmonary fibrosis and ulcerative colitis. It is investigational and has not been approved by the FDA or any other regulatory agency for any indication.

What clinical trials is GLPG1205 in?

GLPG1205 has been studied in two completed Phase 2 trials. NCT03725852 evaluated its efficacy and safety in idiopathic pulmonary fibrosis with 68 participants. NCT02337608 evaluated its efficacy and safety in active ulcerative colitis with 64 participants. Both were randomized, double-blind, and placebo-controlled.

Is GLPG1205 the same as GLPG1205 film-coated tablets or GLPG1205 capsules?

Yes. GLPG1205 film-coated tablets, GLPG1205 capsules, GLPG1205 oral suspension, and GLPG1205 for infusion are all dosage forms of the same investigational compound. The various names, including GLPG1205 50mg q.d. and GLPG1205 250 loading dose and 50mg q.d. maintenance dose, refer to different formulations or dosing regimens used in clinical studies.