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Rheumatoid ArthritisPhase 2NCT03241108

Study of an Anti-TLR4 mAb in Rheumatoid Arthritis

A Phase 2 study testing NI-0101 in people with Rheumatoid Arthritis, run by Light Chain Bioscience - Novimmune SA at 19 sites in 7 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

This is a Phase 2, PoC, randomized, placebo-controlled, double blind, international multicentre study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
NI-0101
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
19 sitesin 7 countries
Study dates
10 May 2017to 20 Jun 2018
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients
  • Age >= 18 years old
  • BMI: < 30 and > 18
  • Diagnosis of RA according to 2010 ACR/EULAR criteria and with a disease duration of at least 6 months since diagnosis
  • Patient must present with active RA, characterized by at least 6 swollen joints out of 66 assessed and 6 tender joints out of 68 assessed and by the presence of synovitis (measured by ultrasound) in at least one of the 6 swollen joints
  • C-reactive protein (CRP) level > 0.7 mg/dL or if the CRP level is between 0.3 mg/dL and 0.7 mg/dL (included) then patient must also present an ESR > 30mm/hr
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  • Patients must have received MTX treatment for at least 3 months and have been on a stable dose of MTX for at least 6 weeks prior to start of screening
  • ACPA-positive RA patients
  • Women must be postmenopausal (> 12 months without menses) or surgically sterile or using two effective contraception methods for at least 4 weeks prior to the randomization date and agree to continue contraception for the duration of their participation in the study (until the end of follow up period)
  • Sexually active male patients must use a barrier method of contraception during the course of the study (and until the end of the follow up period)
  • Patients must give written informed consent for study participation

Who cannot join

  • A documented history of an autoimmune disease other than RA by ACR classification, or Sjögren syndrome
  • Administration of cytotoxic drugs and immune suppressants (other than MTX) within 3 months prior to screening
  • Previous multiple administrations of any biological DMARD or targeted synthetic DMARD
  • Known primary immunodeficiency
  • Pregnant or breastfeeding women
  • Suspicion of active or latent tuberculosis
Show all 13Show fewer
  • HIV, HCV, HBV infection
  • Infection reported during screening not recovered 72h prior to first dose
  • History of anaphylactic reactions to any protein therapeutics or excipients
  • Any history of malignancy, excluding cured basal or squamous cell carcinoma of the skin, or cervical in situ carcinoma
  • Clinically significant cardiac disease requiring medication, such as congestive heart failure, unstable angina, myocardial infarction within 6 months prior to randomization
  • Moderate to severe renal insufficiency, clinically relevant liver function test abnormalities or pancytopenia
  • Major psychiatric or neurological disorder

Trial locations and contacts

19 sites in 7 countries.

19 sites in 7 countries

Georgia6 sites

  • ARENSIA Phase I Unit at the Research Institute of Clinical Medicine

    Tbilisi, 0112

  • High Technology Medical Center; University clinic

    Tbilisi, 0144

  • Emergency Cardiology Center by Acad. G.Chapidze

    Tbilisi, 0159

  • Insitute of Clinical Cardiology

    Tbilisi, 0159

  • Tbilisi Central Hospital

    Tbilisi, 0159

  • Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186

Other trials in Georgia

Bulgaria4 sites

  • Multi-profile Hospital for Active Treatment "Trimontsium"

    Plovdiv, 4000

  • University Multiprofile Hospital for Active Treatment "Kaspela"

    Plovdiv, 4001

  • Multiprofile Hospital for Active Treatment - Shumen AD

    Shumen, 9705

  • University Multiprofile Hospital for Active TreatmenT "St. Ivan Rilski"

    Sofia, 1612

Other trials in Bulgaria

Serbia4 sites

  • Institute of Rheumatology

    Belgrade, 11000

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Special Hospital for Rheumatic Diseases "Novi Sad"

    Novi Sad, 21112

  • General Hospital "Djordje Joanovic"

    Zrenjanin, 23000

Other trials in Serbia

Poland2 sites

  • Centrum Miriada

    Bialystok, 15-297

  • Zespól Poradni Specjalistycznych REUMED

    Lublin, 20-582

Other trials in Poland

Bosnia and Herzegovina1 site

  • Clinic for internal medicine with centre for dialysis

    Mostar, 88000

Other trials in Bosnia and Herzegovina

Hungary1 site

  • CRU Hungary Ltd

    Miskolc, 3529

Other trials in Hungary

Moldova1 site

  • Republican Clinical Hospital, ARENSIA Phase I unit

    Chisinau, MD2025

Other trials in Moldova

About this study

Official title: Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an Anti-Toll Like Receptor 4 Monoclonal Antibody in Patients With Rheumatoid Arthritis

This is a Phase 2, PoC, randomized, placebo-controlled, double blind, international multicentre study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis

Read the detailed description

The study foresees the randomization of at least 81 moderate to severe, ACPA positive, RA patients who are inadequate responders to MTX, in two double blind arms (NI-0101:placebo, with a ratio of 2:1). Patients will receive NI-0101 or placebo infusions up to a maximum of 6 administrations (every two weeks for 12 weeks). All patients will continue receiving a stable dose of MTX. After 12 weeks, patients will enter the follow up period with monthly visits for a minimum of 12 weeks.

Being tested
NI-0101, Placebo
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • NI-0101Drug

    Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody targeting TLR4

  • PlaceboOther

    Placebo

Study groups in NCT03241108
Study groupRoleWhat they receive
NI-0101ExperimentalA therapeutic humanized monoclonal antibody, administered by intravenous infusion every 2 weeks.
Receives: Drug: NI-0101
PlaceboPlacebo comparatorThe placebo matches NI-0101 without active ingredient, administered by intravenous infusion every 2 weeks.
Receives: Other: Placebo

What is being measured

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

  1. Incidence, severity, causality and outcomes of Adverse Events (AEs)

    Incidence, severity, causality and outcomes of Adverse Events (AEs) (serious and non-serious), with particular attention being paid to infusion-related reactions and infections

    Measured: From screening up to 24 weeks after first treatment administration

  2. Withdrawal for safety reasons

    Measured: From randomization up to 24 weeks after first treatment administration

  3. Evolution of laboratory parameters

    Measured: From screening up to 24 weeks after first treatment administration

  4. Level of potential circulating antibodies against NI-0101

    Level of potential circulating antibodies against NI-0101 to determine immunogenicity; i.e. the development of anti-drug antibodies (ADA).

    Measured: From screening up to 24 weeks after first treatment administration

  5. Levels of CRP

    Levels of C-Reactive protein (CRP)

    Measured: From screening up to 24 weeks after first treatment administration

  6. Levels of inflammatory cytokines/chemokines

    IL-6, TNFa, IP-10, MCP-1, sICAM, CXCL13

    Measured: From screening up to 24 weeks after first treatment administration

  7. DAS28 CRP

    Measure of Disease Activity Scores (DAS) for Rheumatism in 28 tender or swollen joints and C-Reactive protein (CRP) - DAS28-CRP

    Measured: From screening to 24 weeks after first treatment administration

  8. ACR criteria

    Proportion of patients achieving American College of Rheumatology Criteria (ACR20, ACR50 and ACR70)

    Measured: From randomization to 24 weeks after first treatment administration

  9. Proportion of patient achieving remission

    Proportion of patient achieving remission (defined as DAS28 < 2.6)

    Measured: From randomization to 24 weeks after first treatment administration

  10. EULAR response

    Proportion of patients achieving European League Against Rheumatism (EULAR) response criteria - good, moderate and no response

    Measured: From randomization to 24 weeks after first treatment administration

  11. Joint Count

    Mean number of Tender Joint Count/Swollen Joint Count.

    Measured: From screening to 24 weeks after first treatment administration

  12. SDAI score

    Mean improvement from baseline in Simplified Disease Activity Index (SDAI) score

    Measured: From randomization to 24 weeks after first treatment administration

  13. HAQ-DI score

    Mean improvement from baseline in the Health Assessment Questionnaire without Disability Index (HAQ-DI) score

    Measured: From randomization to 24 weeks after first treatment administration

  14. SF-36 score

    Mean improvement from baseline in 36-Item Short-Form Health Survey (SF-36) score

    Measured: from randomization to 24 weeks after first treatment administration

  15. DAS28-ESR

    Measure of Disease Activity Scores (DAS) for Rheumatism in 28 tender or swollen joints and Erythrocyte Sedimentation Rate (ESR) levels - DAS28-ESR

    Measured: From screening to 24 weeks after first treatment administration

  16. CDAI score

    Mean improvement from baseline in Clinical Disease Activity Index (CDAI) score scores

    Measured: From randomization to 24 weeks after first treatment administration

  17. Exploratory PK analysis - Cmax

    Peak drug plasma concentration (Cmax)

    Measured: From randomization to 24 weeks after first treatment administration

  18. Exploratory PK analysis - Tmax

    Time when plasma concentration is at peak (Tmax)

    Measured: From screening up to 24 weeks after first treatment administration

  19. Exploratory PK analysis - Ctrough

    Plasma drug concentration immediately prior next dosing (Ctrough)

    Measured: From randomization to 24 weeks after first treatment administration

  20. Exploratory PK analysis - AUC

    Area under the plasma concentration versus time curve (AUC)

    Measured: From randomization to 24 weeks after first treatment administration

  21. Exploratory PK analysis - CL

    Systemic drug clearance (CL)

    Measured: From randomization to 24 weeks after first treatment administration

Timeline

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

  1. First posted7 Aug 2017
  2. Study start10 May 2017
  3. Primary completion20 Jun 2018
  4. Study completion20 Jun 2018

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03241108
Sponsor's protocol ID
NI-0101-04
Other IDs
2016-005017-45, 2016
Status last verified
Aug 2017
First submitted
26 Jun 2017
Last updated
14 Aug 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NI-0101 in people with Rheumatoid Arthritis, run by Light Chain Bioscience - Novimmune SA at 19 sites in 7 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 11 inclusion and 13 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 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Georgia, Bulgaria, Serbia, Poland, Bosnia and Herzegovina and 2 more countries. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence, severity, causality and outcomes of Adverse Events (AEs) (time frame: From screening up to 24 weeks after first treatment administration). The study lists 21 primary outcomes in all. 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 NCT03241108.

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 14 Aug 2018.

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