The BCD-089 (aIL6R) in Patients With Active Rheumatoid Arthritis

NCT03455842 | Completed Phase 2

• 1 other identifier: BCD-089-2
• Study Type: interventional
• Target: 105
• Locations: 2 countries
• Sites: 4

Brief Summary

The study is Phase II randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety, pharmacokinetics and pharmacodynamics of 2 dosing regimens (qw and q2w, s/c) of monoclonal antibody to IL6R (BCD-089) in patients with active rheumatoid arthritis and inadequate response to methotrexate.

Conditions

Seropositive RA

Outcome Measures

Primary Outcomes (1)

• ACR20

  week 12

Secondary Outcomes (17)

• ACR50

  week 4, week 8, week 16, week 24, week 36, week 48, week 52

• ACR70

  week 4, week 8, week 16, week 24, week 36, week 48, week 52

• Low RA activity

  week 4, week 8, week 12, week 16, week 24, week 36, week 48, week 52

• Low RA activity

  week 4, week 8, week 12, week 16, week 24, week 36, week 48, week 52

• Low RA activity

  week 4, week 8, week 12, week 16, week 24, week 36, week 48, week 52

Study Arms (3)

BCD-089 weekly

EXPERIMENTAL

Biological: BCD-089, 162 mg, s/c, qw

BCD-089 biweekly

EXPERIMENTAL

Biological: BCD-089, 162 mg, s/c, q2w

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

BCD-089, 162 mg, s/c, qw BIOLOGICAL

Subcutaneous injections of anti-IL6R every week

BCD-089 weekly

BCD-089, 162 mg, s/c, q2w BIOLOGICAL

Subcutaneous injections of anti-IL6R every other week

BCD-089 biweekly

placebo DRUG

Subcutaneous injections of placebo every week, until week 12. Thereafter subcutaneous injections of anti-IL6R every other week

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Males and females aged 18 - 80 years, at IC signing date.
• Diagnosis of rheumatoid arthritis, according to ACR 2010 criteria, at least for 6 month prior to IC signing date.
• Active rheumatoid arthritis at IC signing date.
• Therapy with methotrexate for at least 3 month prior to IC signing date.
• Stable dose of methotrexate (10-25 mg/week) for 4 weeks prior to IC signing date.
• Persistent activity of RA despite methotrexate (provided by Sponsor) therapy within screening period (4-6weeks).
• Patients, with following parameters of laboratory investigations:
• Hemoglobin ≥ 80 g/l;
• White blood cells ≥ 3,0×109/l;
• Platelets ≥ 100×109/l;
• Neutrophils ≥ 2×109/l;
• ALT and AST \< 1,5 × UNL (according to the local / central laboratory normal values)
• Serum creatinine \< 1,7 × UNL (according to the local / central laboratory normal values)
• Negative urine pregnancy test for women at screening (only for women with childbearing potential - not applied to women at menopause for at least 2 years or surgically sterilized).

You may not qualify if:

• \. History of therapy with tocilizumab or other monoclonal antibodies to IL6R / IL6.
• \. History of therapy with rituximab or other B-cell depleting medicines. 3. Felty's syndrome (any form). 4. ACR1991 functional status IV. 5. Low disease activity of rheumatoid arthritis (DAS28-CRP(4) \< 3,2). 6. Known allergy or intolerance of any investigational drug/placebo ingredients.
• \. Concomitant medication including any of the following:
• Requirement \> 10 mg / day of oral prednisolone (or equivalent);
• Requirement \< 10 mg / day of oral prednisolone (or equivalent), if the dose was not stable for 4 weeks prior the date of informed consent sign (it is allowed to include patients on topical steroids);
• Requirement of NSAID, if dose was not stable for 4 weeks prior the date of informed consent sign (it is allowed to include patients received NSAID occasionally to treat intercurrent fever or allergy).
• Intake of alkalizing agents at any time during 12 month prior the date of IC sign.
• Intraarticular administration of steroids within 4 month prior the date of IC sign
• Vaccination with live or attenuated vaccines at any time during 8 weeks preceding the date of IC sign 8. Leflunomide intake within 8 weeks prior the date of IC sign. 9. Therapy with TNF inhibitors, JAK-inhibitors, T-lymphocyte co-stimulation blockers within 2 month prior to the date of IC sign.
• \. Diagnosis or history of severe immunodeficiency. 11. HIV, HCV, HBV, Syphilis. 12. Diagnosis or history of tuberculosis. 13. Latent TB (positive Diaskin test® or QuantiFERON®-TB Gold or T-SPOT.TB or Mantoux/PPD with lack of TB signs on chest X-ray).
• \. It is allowed to include patients with inconclusive Diaskin test® or QuantiFERON®-TB Gold or T-SPOT.TB or Mantoux/PPD, providing that TB has been ruled out (and documented) by TB-specialist (Phtisyatrician) 15. It is allowed to include patients with positive Mantoux/PPD with no signs of TB on chest X-ray, providing that Diaskin test® or QuantiFERON®-TB Gold or T-SPOT.TB was additionally made with negative results and TB has been ruled out (and documented) by TB-specialist (Phtisyatrician) 16. History of Herpes Zoster. 17. Documented chicken pox within 30 days prior to IC sign 18. Diagnosis of any other chronic infection (sepsis, invasive mycosis, histoplasmosis etc.), which may increase the risk of infectious adverse events.
• \. Any acute infection or chronic infection flare within 30 days prior to informed consent sign, which may increase (according to the PI opinion) the risk of infectious adverse events.
• \. Severe infections (required hospitalization, systemic antimicrobial/antifungal/antiviral treatment) within 6 months prior to date of IC sign.
• \. Systemic antimicrobial, antifungal, antiviral or anthelminthic medication within 2 months prior to fate of IC date.
• \. More than 4 cases of acute respiratory infections within 6 month prior to IC date.

Sponsors & Collaborators

• Biocad: lead

Study Sites (4)

1st City Clinical Hospital

Minsk, Belarus

Location

Chelyabinsk Regional Clinical hospital

Chelyabinsk, Russia

Location

Kazan State Medical University

Kazan', Russia

Location

North-Western State Medical University n.a. I.I.Mechnikov

Saint Petersburg, Russia

Location

Related Publications (1)

• Mazurov V.I., Korolev M.A., Prystrom A.M., Kunder E.V., Soroka N.F., Kastanayan A.A., Povarova T.V., Plaksina T.V., Antipova O.V., Kretchikova D.G., Smakotina S.A., Tciupa O.A., Puntus E.V., Raskina T.A., Shilova L.N., Kropotina T.V., Nesmeyanova O.B., Popova T.A., Vinogradova I.B., Linkova Yu.N., Dokukina E.A., Plotnikova A.V., Pukhtinskaia P.S., Zinkina-Orikhan A.V., Eremeeva A.V., Lutckii A.A. Effectiveness and safety of levilimab in combination with methotrexate in treatment of patients with active rheumatoid arthritis resistant to methotrexate monotherapy (double-blinded randomized placebo controlled phase III clinical study SOLAR). Modern Rheumatology Journal. 2021;15(4):13-23. https://doi.org/10.14412/1996-7012-2021-4-13-23

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

levilimab

Study Officials

• Roman Ivanov, PhD

  Biocad

  STUDY CHAIR

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: February 22, 2018
• First Posted: March 7, 2018
• Study Start: February 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: October 22, 2019
• Last Updated: November 18, 2021

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); RU (3)