Study of the Efficacy and Safety of Goflikicept and Olokizumab as the Second-line Therapy in Patients With Still's Disease

NCT07625384 | Not Yet Recruiting Phase 3

• 1 other identifier: CL04018375
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 25

Brief Summary

The primary objective of the study is to evaluate the efficacy and safety of goflikicept (GFC) and olokizumab (OKZ) in patients with Still's disease

Conditions

Still Disease

Keywords

Still's Disease; Goflikicept; RPH-104; Olokizumab

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who achieved and maintained low disease activity or remission according to DAVID criteria at Day 7 (excluding the arthritis criterion) and achieved DAVID remission criteria at Day 28

  Low disease activity according to DAVID criteria is defined as the absence of fever and the presence of only one of the following criteria: * typical skin rash * arthritis * C-reactive protein (CRP) level \> 10 mg/L * Patient's global assessment of arthritis (PtGA) ≥ 5 cm Remission according to DAVID criteria is defined as the absence of fever, typical skin rash, arthritis, CRP level ≤ 10 mg/L and PtGA \< 5 cm

  Day 7 (low disease activity or remission) and Day 28 (remission)

Secondary Outcomes (23)

• Proportion of patients who developed a flare of Still's disease within 24 weeks after randomization

  at screening, Day 28 (week 4), and every 4 weeks up to Day 168 (week 24)

• Proportion of patients with resolution of fever on Day 3 and Day 7

  Day 3 and Day 7

• Proportion of patients who achieved inactive disease while on low-dose glucocorticosteroids (0.1 mg/kg/day) during the study

  at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)

• Proportion of patients who achieved inactive disease without glucocorticosteroids during the study

  at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)

• Proportion of patients with Disease Activity Score-28 (DAS28) <2.6 during the study

  at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)

Other Outcomes (13)

• Proportion of patients who prematurely discontinued study treatment due to adverse events (AEs)

  Up to Day 252 (Week 36), with follow-up visits at Weeks 4, 8, and 22 (Olokizumab group)

• Number of patients with clinically significant laboratory abnormalities

  at screening and up to Day 252 (week 36)

• Number of patients with clinically significant vital sign abnormalities

  at screening and up to Day 252 (week 36)

Study Arms (3)

Goflikicept

EXPERIMENTAL

Goflikicept is administered at a dose of 320 mg intravenously (IV) infusion on Day 0, followed by 160 mg subcutaneously (SC) on Day 14 and subsequently 160 mg SC every 2 weeks

Biological: Goflikicept

Placebo

PLACEBO COMPARATOR

Placebo is administered at a dose of 320 mg intravenously (IV) infusion on Day 0, followed by 160 mg subcutaneously (SC) on Day 14 and subsequently 160 mg SC every 2 weeks

Drug: Placebo

Olokizumab

OTHER

Participants who do not respond to treatment with Goflikicept (including those switched from placebo) are transitioned to second-line therapy with Olokizumab. Olokizumab is administered at 128 mg intravenously at the initiation visit, followed by response assessment at Day 7. Participants who respond to treatment continue Olokizumab at a dose of 64 mg subcutaneously every 2 weeks during the treatment period

Biological: Olokizumab

Interventions

Placebo DRUG

0.9% Sodium Chloride solution for Injection

Placebo

Goflikicept BIOLOGICAL

solution for subcutaneous injection and intravenous infusion, 40 mg/mL

Also known as: RPH-104, Arcerix

Goflikicept

Olokizumab BIOLOGICAL

solution for subcutaneous injection and intravenous infusion, 160 mg/mL

Also known as: Artlegia

Olokizumab

Eligibility Criteria

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

You may qualify if:

• Voluntarily signed and dated Informed Consent Form (ICF) of the patient agreed to take part in this Study
• Confirmed diagnosis of Adult-Onset Still's Disease (AOSD) based on the Yamaguchi M. diagnostic criteria
• Patient with active disease or low disease activity per DAVID criteria
• In case of current corticosteroid (CS) use, doses must be stable for at least 2 weeks prior to Day 0. The maximum allowed dose of CS is 1 mg/kg/day, up to 60 mg/day (prednisolone equivalent)
• In case of current nonsteroidal anti-inflammatory drugs (NSAID) use, dose of NSAIDs must be stable for at least 2 weeks prior to Day 0
• In case of current methotrexate (MTX) use, the dose of MTX must be stable for at least 4 weeks prior to Day 0. The maximum allowed dose is 30 mg/week. In case of prior MTX discontinuation, it must be performed at least 4 weeks before Day 0
• Patient's ability and willingness, in the reasonable opinion of the investigator, to attend the clinical center for all scheduled visits, perform study procedures, and comply with protocol requirements, including consent to receive subcutaneous injections by qualified personnel
• Women of childbearing potential, defined as all women physiologically capable of becoming pregnant (excluding women who are post-menopausal, defined retrospectively as 12 months of natural amenorrhea with appropriate clinical status, e.g., age-appropriate), must agree to use highly effective methods of contraception throughout the study, starting from the signing of the ICF until at least 8 weeks after the last dose of study treatment; and must have a negative pregnancy test (serum human chorionic gonadotropin, hCG)
• Sexually active male participants must agree to use highly effective methods of contraception throughout the study, starting from the signing of the ICF until at least 8 weeks after the last dose of study treatment

You may not qualify if:

• Hypersensitivity to the active and/or inactive ingredients of the investigational product
• Prior use of the following medications:
• Rilonacept - less than 6 weeks prior to Day 0
• Canakinumab - less than 20 weeks prior to Day 0
• Anakinra - less than 1 week prior to Day 0
• TNF-alpha inhibitors: etanercept less than 2 weeks, adalimumab, certolizumab, or golimumab less than 10 weeks prior to Day 0
• IL-6 inhibitors: olokizumab - less than 20 weeks, tocilizumab - less than 16 weeks, or sarilumab less than 8 weeks prior to Day 0
• Janus kinase (JAK) inhibitors - less than 1 week prior to Day 0
• Immunosuppressants (azathioprine less than 3 days, cyclosporine less than 1 week, mycophenolate mofetil less than 1 week, tacrolimus less than 10 days, mercaptopurine less than 2 days, etc., except for methotrexate) - less than 5 half-lives prior to Day 0
• Leflunomide - less than 10 weeks prior to Day 0
• Corticosteroid pulse therapy (e.g., intravenous methylprednisolone 250-1000 mg/day or equivalent dose of dexamethasone for 3 days) - less than 4 weeks (from the completion of pulse therapy) prior to Day 0
• Intravenous immunoglobulin (IVIG) - less than 4 weeks prior to Day 0
• Other biologic drug with immunosuppressive effects - less than 5 half-lives prior to Day 0
• Use of live-attenuated vaccines within less than 3 months prior to Day 0 (start of the treatment period in the study) and/or anticipated need for such vaccination within 3 months after completion of the investigational therapy. Live-attenuated vaccines include vaccines against measles, rubella, mumps, varicella, rotavirus, influenza (intranasal), yellow fever, poliomyelitis (oral polio vaccine), as well as vaccines against tuberculosis (BCG), typhoid (oral typhoid vaccine), and epidemic typhus. Immunocompetent household members of the patient must refrain from receiving oral polio vaccine during the patient's participation in the study
• Presence of conditions or signs that, in the investigator's opinion, indicate impaired immune response and/or significantly increase the risk associated with immunomodulatory therapy, including but not limited to:

Sponsors & Collaborators

• R-Pharm International, LLC: lead

Study Sites (25)

Republic Clinical and Diagnostic Center of the Ministry of Health of the Udmurt Republic

Izhevsk, 426009, Russia

Location

"Vashe Zdorovie" Research Medical Complex, LLC

Kazan', 420097, Russia

Location

Family Clinic No. 4, LLC

Korolyov, 141060, Russia

Location

Limited Liability Company "OLLA-MED"

Moscow, 105554, Russia

Location

State Budgetary Healthcare Institution "A.S. Loginov Moscow Clinical Scientific Center of the Moscow Department of Healthcare"

Moscow, 111123, Russia

Location

V.A. Nasonova Research Institute of Rheumatology (Federal State Budgetary Scientific Institution)

Moscow, 115522, Russia

Location

Limited Liability Company "Firm ORIS"

Moscow, 117321, Russia

Location

State Budgetary Healthcare Institution of the City of Moscow "N.I. Pirogov City Clinical Hospital No. 1 of the Moscow Department of Healthcare"

Moscow, 119049, Russia

Location

I.M. Sechenov First Moscow State Medical University, University Clinical Hospital No. 3, E.M. Tareev Clinic of Rheumatology, Nephrology and Occupational Pathology

Moscow, 119435, Russia

Location

Russian Gerontology Clinical Research Center (RGNC) of Pirogov Russian National Research Medical University

Moscow, 129226, Russia

Location

"Zdorovaya Semya" Medical Center

Novosibirsk, 630099, Russia

Location

Federal Research Center "Institute of Cytology and Genetics of the Siberian Branch of the Russian Academy of Sciences"

Novosibirsk, 630117, Russia

Location

Budgetary Healthcare Institution of the Omsk Region "Regional Clinical Hospital"

Omsk, 644111, Russia

Location

State Budgetary Healthcare Institution "Orenburg Regional Clinical Hospital named after V.I. Voynov"

Orenburg, 460018, Russia

Location

State Budgetary Healthcare Institution "V.A. Baranov Republican Hospital"

Petrozavodsk, 185000, Russia

Location

Limited Liability Company "Medical Technologies"

Saint Petersburg, 191025, Russia

Location

Interleukin LLC

Saint Petersburg, 194214, Russia

Location

State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital"

Saint Petersburg, 194291, Russia

Location

Limited Liability Company "Medical-Sanitary Unit No. 157" (MSU No. 157)

Saint Petersburg, 196066, Russia

Location

State Healthcare Institution "Regional Clinical Hospital" of Saratov

Saratov, 410053, Russia

Location

Smolensk Regional Rheumatology Center at the "RZD-Medicine" Clinical Hospital (Private Healthcare Institution)

Smolensk, 214025, Russia

Location

Siberian State Medical University (Federal State Budgetary Educational Institution of Higher Education of the Ministry of Health of the Russian Federation)

Tomsk, 634050, Russia

Location

State Budgetary Healthcare Institution "G.G. Kuvatov Republican Clinical Hospital"

Ufa, 450005, Russia

Location

State Healthcare Institution "City Clinical Emergency Hospital No. 25"

Volgograd, 400117, Russia

Location

Yaroslavl State Medical University (Federal State Budgetary Educational Institution of Higher Education of the Ministry of Health of the Russian Federation)

Yaroslavl, 150047, Russia

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

olokizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mikhail Samsonov

  R-Pharm International, LLC

  STUDY DIRECTOR

Central Study Contacts

Olga Sankova

CONTACT

+7 (915) 486-45-25; sankova@rpharm.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Based on the Day 7 disease activity assessment, a decision is made to either continue masked therapy or to unmask and switch to second-line therapy. At the Day 7 assessment, responders remain masked. In the event of non-response at the Day 7 assessment, non-responders are unmasked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 4, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): December 14, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

RU (25)