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Rheumatoid ArthritisPhase 2LADYBUGNCT04577781

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

A Phase 2 study testing GLPG3970 in people with Rheumatoid Arthritis, run by Lakefront Biotherapeutics NV at 9 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
GLPG3970
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
9 sitesin 4 countries
Study dates
12 Oct 2020to 7 Apr 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.
  • Participant testing positive at screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as detected by real time polymerase chain reaction (RT-PCR), participants presenting any signs or symptoms as detected at baseline following careful physical examination (e.g. cough, fever, headaches, fatigue, dyspnea, myalgia, anosmia, dysgeusia, anorexia, sore throat, others) or reporting any signs and symptoms for the 2 preceding weeks, or participants who have been exposed to individuals with confirmed or suspected diagnosis of SARS-CoV-2 within 2 weeks prior to baseline. In addition, any other locally applicable standard diagnostic criteria may also apply to rule out SARS-CoV-2 infection.
  • Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

9 sites in 4 countries.

9 sites in 4 countries

Ukraine3 sites

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

    Kharkiv, 61039

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

    Vinnytsia, 21029

  • Medical Center Clinic of Modern Rheumatology

    Zaporizhzhya, 69005

Other trials in Ukraine

Bulgaria2 sites

  • Medical Center Teodora

    Rousse, 7000

  • UMHAT Sv. Ivan Rilski EAD

    Sofia, 1431

Other trials in Bulgaria

Georgia2 sites

  • Aversi Clinic Ltd

    Tbilisi, 0160

  • Consilium Medulla-multiprofile clinic Ltd

    Tbilisi, 0186

Other trials in Georgia

Poland2 sites

  • Centrum Medyczne Grunwald

    Poznan, 60-369

  • Centrum Badan Klinicznych S.C.

    Poznan, 60-773

Other trials in Poland

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

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).

Being tested
GLPG3970, Placebo
Keywords
Arthritis, Rheumatic Diseases, Moderately active rheumatoid arthritis, Severely active rheumatoid arthritis, Joint Diseases, Autoimmune Diseases, Musculoskeletal Diseases, Musculoskeletal and connective tissue disorders
Medical subject headings
Arthritis, Rheumatoid, Arthritis, Rheumatic Diseases, Joint Diseases, Autoimmune Diseases, Musculoskeletal Diseases, Connective Tissue Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLPG3970Drug

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

  • PlaceboDrug

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

Study groups in NCT04577781
Study groupRoleWhat they receive
GLPG3970ExperimentalParticipants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.
Receives: Drug: GLPG3970
PlaceboPlacebo comparatorParticipants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 6

Secondary outcomes (2)

  1. Number of Participants With Treatment Emergent Adverse Events

    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;

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

  2. Plasma Concentration (Ctrough) of GLPG3970

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start12 Oct 2020
  3. Primary completion26 Mar 2021
  4. Study completion7 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04577781
Sponsor's protocol ID
GLPG3970-CL-209
Other IDs
2020-000658-83
Acronym
LADYBUG
Status last verified
Mar 2022
First submitted
30 Sep 2020
Last updated
18 Jul 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GLPG3970 in people with Rheumatoid Arthritis, run by Lakefront Biotherapeutics NV at 9 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Ukraine, Bulgaria, Georgia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in DAS-28 (CRP) at Week 6 (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04577781.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.

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LADYBUG Clinical Trial NCT04577781 | AzTrials