Trial Outcomes & Findings for 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 (NCT NCT04577781)

Last Updated: 2022-07-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

Baseline and Week 6

Results posted on

2022-07-18

Participant Flow

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.

Participants remained on a stable dose (10 to 20 mg/week) of MTX as background medication.

Participant milestones

Participant milestones
Measure	GLPG3970 Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.	Placebo Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
Overall Study STARTED	16	12
Overall Study COMPLETED	13	10
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	GLPG3970 Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.	Placebo Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
Overall Study Adverse Event	2	2
Overall Study Physician Decision	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GLPG3970 n=16 Participants Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks.	Placebo n=12 Participants Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.	Total n=28 Participants Total of all reporting groups
Age, Continuous	45.9 years STANDARD_DEVIATION 11.3 • n=5 Participants	41.4 years STANDARD_DEVIATION 8.6 • n=7 Participants	44.0 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Disease Activity Score Based on 28 Joints C-reactive Protein [DAS28 (CRP)]	6.13 Score on a scale STANDARD_DEVIATION 0.87 • n=5 Participants	5.68 Score on a scale STANDARD_DEVIATION 0.88 • n=7 Participants	5.93 Score on a scale STANDARD_DEVIATION 0.89 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 6

Population: 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.

Outcome measures

Outcome measures
Measure	GLPG3970 n=13 Participants Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks.	Placebo n=10 Participants Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
Change From Baseline in DAS-28 (CRP) at Week 6	-1.29 Score on a scale Standard Error 0.224	-1.24 Score on a scale Standard Error 0.258

SECONDARY outcome

Timeframe: From first dose of study drug until end of the study (up to 8 weeks)

Population: Participants in the safety analysis set

Treatment-Emergent Adverse Events (TEAE) were defined as * Any adverse event (AE) with an onset date on or after the IP start date and no later than 14 days after last dose of IP, or worsening of any AE on or after the IP start date. * Improvement or no change of any ongoing AEs on or after the IP start date are not considered treatment-emergent. If an AE was ongoing at the time of first IP intake and if there was no change or an improvement in its toxicity grade or its seriousness status, this AE was not considered as treatment-emergent. Serious TEAE was defined as a TEAE that * Resulted in death and was life-threatening; * Required in-patient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly / birth defect; * Was medically significant;

Outcome measures

Outcome measures
Measure	GLPG3970 n=16 Participants Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks.	Placebo n=12 Participants Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
Number of Participants With Treatment Emergent Adverse Events Serious TEAE	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events TEAE	6 Participants	2 Participants
Number of Participants With Treatment Emergent Adverse Events TEAE leading to death	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events Treatment related TEAE	4 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events TEAEs leading to study drug discontinuation	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose

Population: 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.

Ctrough was defined as plasma concentration level at the end of the dosing interval.

Outcome measures

Outcome measures
Measure	GLPG3970 n=11 Participants Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks.	Placebo Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
Plasma Concentration (Ctrough) of GLPG3970 Day 15: Pre-dose	95.3 Nanogram per milliliter Geometric Coefficient of Variation 115	—
Plasma Concentration (Ctrough) of GLPG3970 Day 29: Pre-dose	103 Nanogram per milliliter Geometric Coefficient of Variation 73.8	—
Plasma Concentration (Ctrough) of GLPG3970 Day 43: Pre-dose	49.8 Nanogram per milliliter Geometric Coefficient of Variation 697	—

Adverse Events

GLPG3970

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	GLPG3970 n=16 participants at risk Participants received 400 mg GLPG3970 oral solution, QD for a period 6 weeks.	Placebo n=12 participants at risk Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
Investigations Alanine aminotransferase increased	12.5% 2/16 • Number of events 2 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set	0.00% 0/12 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set
Investigations Lipase increased	6.2% 1/16 • Number of events 1 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set	8.3% 1/12 • Number of events 1 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set
Investigations SARS-CoV-2 test positive	6.2% 1/16 • Number of events 1 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set	0.00% 0/12 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set
Gastrointestinal disorders Constipation	0.00% 0/16 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set	8.3% 1/12 • Number of events 1 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set
Gastrointestinal disorders Dyspepsia	12.5% 2/16 • Number of events 2 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set	0.00% 0/12 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set
Hepatobiliary disorders Cholelithiasis	6.2% 1/16 • Number of events 1 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set	0.00% 0/12 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set
Hepatobiliary disorders Hepatitis	6.2% 1/16 • Number of events 1 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set	0.00% 0/12 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set
Metabolism and nutrition disorders Hyperglycaemia	6.2% 1/16 • Number of events 1 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set	0.00% 0/12 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set
Infections and infestations Nasopharyngitis	0.00% 0/16 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set	8.3% 1/12 • Number of events 1 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set
Infections and infestations COVID-19	0.00% 0/16 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set	8.3% 1/12 • Number of events 1 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set
Infections and infestations Pharyngitis	6.2% 1/16 • Number of events 1 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set	0.00% 0/12 • From first dose of study drug until end of the study (up to 8 weeks) Safety analysis set

Additional Information

Galapagos Medical Information

Galapagos NV

Phone: +32 15 342 900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER