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

NCT04577781 | Completed Phase 2 Results DMC

• 2 other identifiers: GLPG3970-CL-2092020-000658-83
• Study Type: interventional
• Target: 28
• Locations: 4 countries
• Sites: 9

Brief Summary

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).

Conditions

Rheumatoid Arthritis

Keywords

Arthritis; Rheumatic Diseases; Moderately active rheumatoid arthritis; Severely active rheumatoid arthritis; Joint Diseases; Autoimmune Diseases; Musculoskeletal Diseases; Musculoskeletal and connective tissue disorders

Outcome Measures

Primary Outcomes (1)

• 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. * 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.

  Baseline and Week 6

Secondary Outcomes (2)

• 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

Study Arms (2)

GLPG3970

EXPERIMENTAL

Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.

Drug: GLPG3970

Placebo

PLACEBO COMPARATOR

Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.

Drug: Placebo

Interventions

GLPG3970 DRUG

GLPG3970 powder and solvent for oral solution to be reconstituted prior to use.

GLPG3970

Placebo DRUG

Placebo powder and solvent for oral solution to be reconstituted prior to use.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A body mass index (BMI) between 18-32 kg/m\^2, inclusive.
• 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.
• Have ≥6 swollen joints (from a swollen joint count evaluated in 66 joints \[SJC66\]) AND ≥8 tender joints (from a tender joint count evaluated in 68 joints \[TJC68\]) at screening and at the baseline visit (Visit 1) prior to the first investigational product (IP) dosing.
• DAS28 (CRP) \>3.2 (moderate disease) at screening.
• Screening serum high sensitivity C-reactive protein (hsCRP) \> upper limit of normal (ULN, central laboratory reference: ≤ 5.0 mg/L).
• Inadequate response to MTX, i.e. treatment-experienced participants who demonstrated inadequate clinical response during treatment with MTX.
• Have received MTX for ≥6 months and on stable dose (10 to 20 mg/week) of MTX for at least 4 weeks prior to screening and willing to continue on their current stable dose and dosing regimen for the duration of the study.
• If taking systemic steroids, prednisone equivalent at a dose of ≤10 mg/day and stable for at least 4 weeks prior to the first IP dosing.

You may not qualify if:

• Current therapy with any conventional disease-modifying antirheumatic drug (DMARD) other than MTX, including
• oral or injectable gold, sulfasalazine, antimalarials, azathioprine, or D-penicillamine within 4 weeks prior to screening,
• cyclosporine within 8 weeks prior to screening, and
• leflunomide within 3 months prior to screening or a minimum 4 weeks prior to screening if after 11 days of standard cholestyramine therapy.
• Current or previous treatment with a biologic DMARD (bDMARD). Except for participants who received bDMARDs only in a single clinical study setting:
• For whom the last dose of bDMARD ≥6 months prior to screening (12 months for rituximab or other lymphocyte depleting agents), AND;
• For whom the bDMARD was effective, without being discontinued due to lack of efficacy.
• 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:
• Positive QuantiFERON-TB Gold test result at screening, OR
• Chest radiograph (posterior anterior view) taken within 12 weeks prior to screening, read by a qualified radiologist or pulmonologist, with evidence of current active TB or old inactive TB.
• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (9)

Medical Center Teodora

Rousse, 7000, Bulgaria

Location

UMHAT Sv. Ivan Rilski EAD

Sofia, 1431, Bulgaria

Location

Aversi Clinic Ltd

Tbilisi, 0160, Georgia

Location

Consilium Medulla-multiprofile clinic Ltd

Tbilisi, 0186, Georgia

Location

Centrum Medyczne Grunwald

Poznan, 60-369, Poland

Location

Centrum Badan Klinicznych S.C.

Poznan, 60-773, Poland

Location

GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

Kharkiv, 61039, Ukraine

Location

SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU

Vinnytsia, 21029, Ukraine

Location

Medical Center Clinic of Modern Rheumatology

Zaporizhzhya, 69005, Ukraine

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis; Rheumatic Diseases; Joint Diseases; Autoimmune Diseases; Musculoskeletal Diseases; Connective Tissue Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Immune System Diseases

Results Point of Contact

• Title: Galapagos Medical Information
• Organization: Galapagos NV

medicalinfo@glpg.com

+32 15 342 900

Study Officials

• Galapagos Medical Director

  Galapagos NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 8, 2020
• Study Start: October 12, 2020
• Primary Completion: March 26, 2021
• Study Completion: April 7, 2021
• Last Updated: July 18, 2022
• Results First Posted: July 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BU (2); UA (3); PL (2); GE (2)