Recent Updates
Recently added Catalysts

GLPG1690

Phase 3

Idiopathic Pulmonary Fibrosis | Small molecule | Respiratory |Lakefront Biotherapeutics|Trials Updated: May 4, 2021

GLPG1690 development status

Highest phase Phase 3 (NCT03711162)
Phase scored for LKFTPhase 2
Registered trials 7 across 1 sponsor since Jul 2014

GLPG1690 target and mechanism

ModalitySmall molecule

Also known as GLPG1690 single ascending doses, GLPG1690 film-coated tablets, GLPG1690 film-coated, [14C]-GLPG1690 solution for infusion, GLPG1690 for infusion, [14C]-GLPG1690 capsules

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment56

FDA Designations

No designations recorded

GLPG1690 clinical trials

GLPG1690 · 2 trials · 2 indications

Phase 2 2
NCT03798366A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Systemic SclerosisSystemic Sclerosis
COMPLETED33 Analytics
NCT02738801Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis
COMPLETED23 Analytics
PHASE2COMPLETED
A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Systemic Sclerosis
Systemic SclerosisUnlock trial analytics
PHASE2COMPLETED
Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in mRSS at Week 4
Baseline, Week 4

The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.

Change From Baseline in mRSS at Week 8
Baseline, Week 8

The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.

Change From Baseline in mRSS at Week 16
Baseline, Week 16

The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.

Change From Baseline in mRSS at Week 24
Baseline, Week 24

The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.

Number of Patients With Treatment-Emergent Adverse Events (AEs)
From screening up to Day 98
Mean Maximum Observed Plasma Concentration (Cmax; Micrograms Per Milliliter [µg/mL]) of GLPG1690
Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28
Median Time to Occurrence of GLPG1690 Cmax (Tmax; Hours [h])
Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28
Mean Area Under the Plasma Concentration-Time Curve (AUC[t]; µg.h/mL) of GLPG1690
Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28
Mean GLPG1690 Plasma Concentration Observed at Predose (Ctrough; µg/mL)
Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28
Mean Peak Area Ratio of Lysophosphatidic Acid (LPA) C18:2 Species in Blood
Baseline (Day -1), predose and 1.5 and 6 hours postdose on Day 28, predose on Day 84, and Day 98 (or early discontinuation)

LPA species C18:2 concentrations were determined in blood using a validated liquid chromatography tandem mass spectometry (LC/MS-MS) method. The baseline reference timepoint was Day -1 (mean of the pre-dosing duplicates).

Mean Peak Area Ratio of LPA C18:2 Species in Bronchoalveolar Lavage Fluid (BALF)
Baseline (Day -1) and Day 84

LPA species C18:2 concentrations were determined in BALF using a validated LC/MS-MS method. The baseline reference timepoint was Day -1 (mean of the pre-dosing duplicates).

Secondary Endpoints

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Baseline up to end of the study (36 weeks)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GLPG1690 600 mgEXPERIMENTALParticipants received GLPG1690 600 milligrams (mg), orally once daily for 24 weeks.
PlaceboPLACEBO_COMPARATORParticipants received GLPG1690 matching placebo, orally once daily for 24 weeks.
GLPG1690 600 mg once daily (QD)EXPERIMENTAL -
Placebo QDPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
GLPG1690DRUGFilm-coated tablets of GLPG1690 for oral use.
PlaceboDRUGFilm-coated tablets of GLPG1690 matching placebo for oral use.
GLPG1690 600 mg QDDRUGGLPG1690 capsules, administered at a dose of 600 mg, orally QD
Placebo QDDRUGMatching placebo capsules, administered orally QD
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Able and willing to comply with the protocol requirements and to sign the informed consent form (ICF) as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations. * Male and female participants ≥18 years at the tim...

Countries:United StatesBelgiumGermanyItalySpainUnited KingdomUkraine
Unlock Eligibility Criteria

Frequently asked questions about GLPG1690

What is GLPG1690 used for?

GLPG1690 is an investigational small molecule being studied for the treatment of idiopathic pulmonary fibrosis and systemic sclerosis. It has been evaluated in Phase 2 clinical trials in both of these respiratory and fibrotic conditions. It is not approved for any indication.

Who is developing GLPG1690?

GLPG1690 is being developed by Lakefront Biotherapeutics, which trades under the ticker LKFT. The company is the sponsor of the clinical program evaluating GLPG1690 in idiopathic pulmonary fibrosis and systemic sclerosis.

What phase is GLPG1690 in?

GLPG1690 is in Phase 2 clinical development. It has completed Phase 2 trials in idiopathic pulmonary fibrosis and systemic sclerosis. It is investigational and has not been approved by the FDA or any other regulatory agency.

What clinical trials is GLPG1690 in?

GLPG1690 has been studied in two completed Phase 2 trials. NCT03798366 evaluated its effectiveness and safety in participants with systemic sclerosis across the United States, Belgium, Germany, Italy, Spain, and the United Kingdom. NCT02738801 assessed safety, tolerability, pharmacokinetics, and pharmacodynamics in subjects with idiopathic pulmonary fibrosis in Ukraine and the United Kingdom.

Is GLPG1690 the same as GLPG1690 film-coated tablets?

Yes, GLPG1690 film-coated tablets is one of several formulations and study labels used for the same investigational drug, GLPG1690. Other names include GLPG1690 oral suspension, GLPG1690 for infusion, [14C]-GLPG1690 solution for infusion, [14C]-GLPG1690 capsules, and GLPG1690 600 mg QD.