Polymyalgia RheumaticaPhase 3NCT07670546
Efficacy and Safety of Olokizumab in Patients With Polymyalgia Rheumatica (PROMISE)
A Phase 3 study testing Olokizumab in people with Polymyalgia Rheumatica, run by R-Pharm International, LLC at 20 sites in Russia.
Trial summary
The primary objective of the study is to evaluate the efficacy of olokizumab (OKZ) 64 mg administered subcutaneously every 2 weeks compared with placebo in participants with polymyalgia rheumatica (PMR). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Polymyalgia Rheumatica
- What is being tested?
- Olokizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 20 sitesRussia
- Study dates
- 11 Jun 2025to 9 Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of written informed consent (IC) signed by the participant
- Confirmed diagnosis of polymyalgia rheumatica (PMR) according to the 2012 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria
- At the time of randomization, participants must meet one of the following conditions:
- stable glucocorticoid (GC) therapy at a dose of ≤20 mg/day prednisone equivalent for at least 2 weeks; or
- no glucocorticoid (GC) therapy for at least 2 weeks
- PMR flare within 3 days prior to randomization meeting the following criteria:
- Polymyalgia Rheumatica Activity Score (PMR-AS) ≥10;
- C-reactive protein (CRP) level ≥5 mg/L in the absence of alternative causes of elevation
Who cannot join
- Presence of cranial symptoms of giant cell arteritis (GCA) within 12 weeks prior to screening
- Presence of concomitant fibromyalgia or neuropathic pain syndrome
- Presence of other systemic rheumatic diseases, including rheumatoid arthritis, Sjögren's syndrome, vasculitis (except GCA), dermatomyositis/polymyositis, and others
- Presence of concomitant conditions associated with chronic pain syndrome that could potentially interfere with efficacy assessments in the study
- Bilateral limitation of upper limb elevation above 90° (elevation of upper limbs [EUL] score 1) not related to active polymyalgia rheumatica (PMR)
- Requirement for systemic glucocorticoid (GC) therapy for conditions other than PMR
Show all 54Show fewer
- Prior treatment with interleukin-6 (IL-6) inhibitors (including OKZ) or IL-6 receptor inhibitors, except when used for treatment of coronavirus disease 2019 (COVID-19). For participants treated with these agents for COVID-19, the last administration must have occurred at least 6 months prior to screening
- Intravenous, intra-articular, periarticular, or intramuscular glucocorticoid administration within 4 weeks prior to screening
- Use of the following medications prior to screening:
- Janus kinase (JAK) inhibitors (including tofacitinib, baricitinib, or upadacitinib) within 4 weeks;
- Tumor necrosis factor-alpha (TNF-α) inhibitors: etanercept within 2 weeks; adalimumab, golimumab, certolizumab, or infliximab within 8 weeks;
- Rituximab within 12 months prior to screening;
- Abatacept within 8 weeks prior to screening;
- Interleukin-1 (IL-1) inhibitors: canakinumab within 12 weeks; anakinra within 72 hours; goflikicept within 8 weeks;
- Interleukin-17 (IL-17), interleukin-23 (IL-23), or interleukin-12/23 (IL-12/23) inhibitors: secukinumab, bimekizumab, ustekinumab, tildrakizumab, risankizumab, mirikizumab, or netakimab within 16 weeks; ixekizumab, brodalumab, or guselkumab within 12 weeks;
- Other genetically engineered biologic therapies within at least 5 half-lives prior to screening;
- Alkylating agents, including cyclophosphamide, within 24 weeks;
- Cyclosporine, azathioprine, or mycophenolate mofetil within 4 weeks
- Initiation, discontinuation, or dose modification of methotrexate or leflunomide within 12 weeks prior to screening
- Modification of other PMR therapy within 4 weeks or 5 half-lives prior to screening, whichever is longer
- Administration of a live vaccine within 6 weeks prior to baseline assessment or planned live vaccination during the study
- Participation in another clinical study within 30 days prior to baseline assessment or within 5 half-lives of the investigational product used in that study, whichever is longer
- Previous participation in this study (participant randomized and received at least one dose of investigational product)
- Hematologic disorders, including platelet, leukocyte, or erythrocyte disorders (e.g., sickle cell anemia, myelodysplastic syndrome, hematologic malignancies, multiple myeloma, hemolytic anemia, or thalassemia) or coagulopathies
- Current malignancy or history of malignancy within the past 5 years, except adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin carcinoma treated at least 1 year prior to screening (with no more than 3 excised skin cancers within 5 years prior to screening)
- Screening laboratory abnormalities including:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 × upper limit of normal (ULN);
- Platelet count <100 × 10^9/L (<100,000/mm^3);
- White blood cell count <3.5 × 10^9/L;
- Absolute neutrophil count <2,000 × 10^6/L (<2,000/mm^3)
- Positive human immunodeficiency virus (HIV) test at screening or history of HIV infection
- Screening evidence of hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection:
- Participants previously treated for HCV infection with undetectable viral load for at least 6 months may be eligible with specialist approval;
- Participants positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (anti-HBc) are excluded;
- Participants with isolated positive hepatitis B surface antibody (anti-HBs) and prior vaccination history may be eligible
- History of active tuberculosis (TB); suspected or confirmed active TB; radiographic evidence of active pulmonary TB at screening; or TB risk factors including recent incarceration, homelessness, occupational exposure, or close contact with individuals with active TB within 1 year prior to randomization
- History of latent tuberculosis infection (LTBI) without adequate treatment regardless of QuantiFERON-TB/T-SPOT.TB results, or positive QuantiFERON-TB/T-SPOT.TB test at screening. Participants may be re-screened if active TB is excluded by a qualified specialist, at least 30 days of prophylactic therapy for LTBI have been completed, and the participant agrees to complete the recommended course of therapy
- Participants with the following cardiovascular diseases:
- Decompensated congestive heart failure or New York Heart Association (NYHA) Class III or IV heart failure;
- Resistant or uncontrolled hypertension requiring adjustment of antihypertensive therapy;
- Severe or uncontrolled cardiovascular disease, including acute coronary syndrome, stroke, or transient ischemic attack within 3 months prior to screening
- Any severe and/or uncontrolled concomitant disease (including uncontrolled severe hyperlipidemia, uncontrolled diabetes mellitus, respiratory, hepatic, renal, gastrointestinal, endocrine, dermatologic, neurologic, psychiatric, hematologic, immunologic, or immunodeficiency disorders) that, in the investigator's opinion, may interfere with study participation or interpretation of study results
- Acute infection at screening, exacerbation of chronic infection, infection requiring oral antimicrobial therapy within 4 weeks prior to screening, injectable antimicrobial therapy within 6 weeks prior to randomization, or severe/recurrent infections requiring hospitalization within 6 months prior to randomization
- History within 6 months prior to screening of disseminated herpes zoster infection, herpes zoster-associated encephalitis or meningitis, or other severe herpes zoster infections not resolving without treatment
- Any other clinically significant chronic infection (including invasive fungal infections or osteomyelitis) that, in the investigator's opinion, may increase the risk of infectious complications during the study
- Planned surgical intervention during the study, surgery within 4 weeks prior to screening (except minimally invasive diagnostic procedures), or incomplete recovery from surgery in the investigator's opinion
- History or presence of diverticulitis, ulcerative colitis, Crohn's disease, gastrointestinal perforation, or other gastrointestinal conditions associated with increased risk of perforation
- Alcohol or substance abuse in the investigator's opinion
- Pregnancy, breastfeeding, or planned pregnancy during the study or within 6 months after the last dose of investigational treatment
- Women of childbearing potential unwilling to use highly effective contraception during the study and for 6 months after the last dose of investigational product, or men with partners of childbearing potential unwilling to use highly effective contraception during the study and for at least 3 months after the last dose of investigational product
- Known hypersensitivity to OKZ, any component of the investigational product, or placebo
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- Unwillingness or inability to comply with study procedures required by the protocol
- Any medical, psychiatric, or laboratory abnormality that, in the investigator's opinion, may increase the risk associated with study participation or interfere with interpretation of study results, making the participant unsuitable for the study
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Russia20 sites
Udmurt Republic Clinical and Diagnostic Center, Ministry of Health of the Udmurt Republic
Izhevsk, 426009
Family Polyclinic No. 4 LLC
Korolyov, 141060
A.S. Loginov Moscow Clinical Scientific Center
Moscow, 111123
V.A. Nasonova Research Institute of Rheumatology
Moscow, 115522
I.M. Sechenov First Moscow State Medical University, Center for Clinical Studies of Medicinal Products
Moscow, 119435
M.F. Vladimirsky Moscow Regional Research and Clinical Institute (MONIKI)
Moscow, 129110
Russian Gerontology Research and Clinical Center, Pirogov Russian National Research Medical University
Moscow, 129226
N.A. Semashko Nizhny Novgorod Regional Clinical Hospital
Nizhny Novgorod, 603126
Healthy Family Medical Center LLC
Novosibirsk, 630099
Research Institute of Clinical and Experimental Lymphology - Branch of the Federal Research Center Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences
Novosibirsk, 630117
Omsk Regional Clinical Hospital
Omsk, 644012
Academician I.P. Pavlov Ryazan State Medical University
Ryazan, 390026
Interleukin LLC
Saint Petersburg, 194214
Medical and Sanitary Unit No. 157 LLC
Saint Petersburg, 196066
Smolensk Regional Rheumatology Center at the Clinical Hospital "RZD-Medicine" of the City of Smolensk (Private Healthcare Institution)
Smolensk, 214025
Siberian State Medical University, Ministry of Health of the Russian Federation
Tomsk, 634050
State Budgetary Healthcare Institution Republican Clinical Hospital named after G.G. Kuvatov
Ufa, 450005
Biomed LLC
Vladimir, 600005
Yaroslavl Central City Hospital
Yaroslavl, 150047
Center for Medical Consultations and Research - PRAKTIKA LLC
Yaroslavl, 150054
About this study
Official title: An International, Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Efficacy and Safety of Olokizumab in Patients With Polymyalgia Rheumatica
The primary objective of the study is to evaluate the efficacy of olokizumab (OKZ) 64 mg administered subcutaneously every 2 weeks compared with placebo in participants with polymyalgia rheumatica (PMR). The secondary objectives are to evaluate the steroid-sparing effect, inflammatory markers, safety, tolerability, immunogenicity, and pharmacokinetics of OKZ in participants with PMR compared with placebo. The exploratory objectives are to evaluate OKZ efficacy in selected participant subgroups, biomarkers of bone metabolism, pharmacodynamic parameters, glucocorticoid-related effects, and quality of life in participants with PMR compared with placebo
Read the detailed description
This is a Phase 3, double-blind, placebo-controlled, parallel-group study. A total of 120 participants with active polymyalgia rheumatica are planned to be randomized in a 1:1 ratio to one of the following treatment arms:
- OKZ arm: subcutaneous injections of OKZ 64 mg every 2 weeks
- Placebo arm: subcutaneous placebo injections every 2 weeks
Participants may continue stable methotrexate or leflunomide therapy during the screening and treatment periods
The treatment period lasts 16 weeks, during which participants visit the study center every 2 weeks for safety assessments and evaluation of treatment response. Starting from Week 6 (Visit 4), in participants with PMR-AS <10, a gradual weekly glucocorticoid taper is initiated, decreasing by 2.5 mg/week until a dose of 5 mg/day is reached, followed by reductions of 1.25 mg/week until complete discontinuation of glucocorticoids. If complete discontinuation is not feasible at a dose of 5 mg/day or lower, tapering may be paused based on the investigator's clinical judgment
Participants who do not enter an open-label extension study after completion of the 16-week double-blind treatment period enter a 22-week safety follow-up (SFU) period. During follow-up, participants attend clinic visits at 2, 10, and 22 weeks after the end-of-treatment (EOT) visit for SFU assessments. The total duration of the study for participants is approximately 42 weeks
- Conditions
- Polymyalgia Rheumatica
- Being tested
- Olokizumab, Placebo
- Keywords
- Polymyalgia Rheumatica, Olokizumab, Artlegia
- Medical subject headings
- Polymyalgia Rheumatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlokizumabBiological
Also called Artlegia
Solution for subcutaneous injection in a prefilled syringe (1 mL) with a concentration of 160 mg/mL, administered as a 64 mg/0.4 mL dose
PlaceboDrug
0.9% Sodium Chloride solution for Injection
| Study group | Role | What they receive |
|---|---|---|
| Olokizumab | Experimental | Olokizumab 64 mg every 2 weeks, administered as a single 0.4 mL subcutaneous injection Receives: Biological: Olokizumab |
| Placebo | Placebo comparator | Placebo every 2 weeks, administered as a single 0.4 mL subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of treatment response
Treatment response is defined as Polymyalgia Rheumatica Activity Score (PMR-AS) <10 and glucocorticoid (GC) dose ≤5 mg/day, or a reduction of ≥10 mg/day, or no new initiation of GC therapy (in participants not receiving GC at baseline), up to Week 16
Measured: Up to Week 16 (visit 9)
Secondary outcomes (14)
Proportion of participants with Polymyalgia Rheumatica Activity Score (PMR-AS) <7 at each visit
PMR-AS index is calculated (to two decimal places) as the sum of five variables: duration of morning stiffness in minutes (MST, morning stiffness), multiplied by 0.1; elevation of the upper limbs (EUL, scored from 0 to 3); physician global assessment of disease activity using a 10-point visual analogue scale (VASphys); patient-reported pain intensity using a 10-point visual analogue scale (VASpain); and C-reactive protein (CRP) level (mg/dL)
Measured: Up to Week 16 (visit 9)
Proportion of participants with Polymyalgia Rheumatica Activity Score (PMR-AS) <10 at each visit
PMR-AS index is calculated (to two decimal places) as the sum of five variables: duration of morning stiffness in minutes (MST, morning stiffness), multiplied by 0.1; elevation of the upper limbs (EUL, scored from 0 to 3); physician global assessment of disease activity using a 10-point visual analogue scale (VASphys); patient-reported pain intensity using a 10-point visual analogue scale (VASpain); and C-reactive protein (CRP) level (mg/dL)
Measured: Up to Week 16 (visit 9)
Change in Polymyalgia Rheumatica Activity Score (PMR-AS) over the treatment period compared with baseline
PMR-AS index is calculated (to two decimal places) as the sum of five variables: duration of morning stiffness in minutes (MST, morning stiffness), multiplied by 0.1; elevation of the upper limbs (EUL, scored from 0 to 3); physician global assessment of disease activity using a 10-point visual analogue scale (VASphys); patient-reported pain intensity using a 10-point visual analogue scale (VASpain); and C-reactive protein (CRP) level (mg/dL)
Measured: Baseline and Week 16 (visit 9)
Change from baseline in pain assessed using a visual analogue scale (VASpain)
Change from baseline in pain assessed by the patient using a visual analogue scale (VASpain). VASpain range: 0 to 10; where 0= no activity and 10= maximum activity
Measured: Baseline and Week 16 (visit 9)
Change from baseline in duration of morning stiffness
Change from baseline in duration of morning stiffness measured in minutes
Measured: Baseline and Week 16 (visit 9)
Change from baseline in upper limb elevation score
Change from baseline in upper limb elevation assessed on a 0-3 scale. Higher scores indicate worse outcome
Measured: Baseline and Week 16 (visit 9)
Change from baseline in investigator-assessed disease activity
Change from baseline in disease activity assessed by the investigator using a visual analogue scale (VASphys). VASphys range: 0 to 10; where 0= no activity and 10= maximum activity
Measured: Baseline and Week 16 (visit 9)
Proportion of participants with new initiation or dose increase of glucocorticoids
Proportion of participants with new initiation of glucocorticoid (GC) therapy or an increase in GC dose compared with baseline
Measured: Baseline and Week 16 (visit 9)
Change in proportion of participants receiving glucocorticoids over time
Change from baseline in the proportion of participants receiving glucocorticoids (GC), overall and in subgroups of participants receiving or not receiving GC at baseline
Measured: Baseline and Week 16 (visit 9)
Change from baseline in mean glucocorticoid dose
Change from baseline in mean daily glucocorticoid dose in each treatment arm
Measured: Baseline and Week 16 (visit 9)
Cumulative glucocorticoid dose
Total cumulative glucocorticoid dose during the treatment period
Measured: Baseline and Week 16 (visit 9)
Change from baseline in C-reactive protein (CRP) levels
Change from baseline in serum C-reactive protein (CRP) levels during the treatment period
Measured: Baseline and Week 16 (visit 9)
Change from baseline in erythrocyte sedimentation rate (ESR)
Change from baseline in erythrocyte sedimentation rate (ESR) during the treatment period
Measured: Baseline and Week 16 (visit 9)
Change from baseline in patient global assessment of disease activity
Physician global assessment of disease activity (VAS range: 0 to 10; where 0= no activity and 10= maximum activity). Higher scores indicate better outcome
Measured: Baseline and Week 16 (visit 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start11 Jun 2025
- Primary completion10 Apr 2026
- Study completion9 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymyalgia RheumaticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm International, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mikhail Samsonov, Study director, R-Pharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670546
- Sponsor's protocol ID
- CL04041376
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Efficacy and Safety of Olokizumab in Patients With Polymyalgia Rheumatica
- ClinicalTrials.gov ID
- NCT07670546
- Acronym / sponsor ID
- CL04041376
- Conditions
- Polymyalgia Rheumatica
- Keywords
- Polymyalgia Rheumatica, Olokizumab, Artlegia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (actual)
- Lead sponsor
- R-Pharm International, LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 9 Jul 2026 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the efficacy of olokizumab (OKZ) 64 mg administered subcutaneously every 2 weeks compared with placebo in participants with polymyalgia rheumatica (PMR). The secondary objectives are to evaluate the steroid-sparing effect, inflammatory markers, safety, tolerability, immunogenicity, and pharmacokinetics of OKZ in participants with PMR compared with placebo. The exploratory objectives are to evaluate OKZ efficacy in selected participant subgroups, biomarkers of bone metabolism, pharmacodynamic parameters, glucocorticoid-related effects, and quality of life in participants with PMR compared with placebo
Detailed description
This is a Phase 3, double-blind, placebo-controlled, parallel-group study. A total of 120 participants with active polymyalgia rheumatica are planned to be randomized in a 1:1 ratio to one of the following treatment arms:
- OKZ arm: subcutaneous injections of OKZ 64 mg every 2 weeks
- Placebo arm: subcutaneous placebo injections every 2 weeks
Participants may continue stable methotrexate or leflunomide therapy during the screening and treatment periods
The treatment period lasts 16 weeks, during which participants visit the study center every 2 weeks for safety assessments and evaluation of treatment response. Starting from Week 6 (Visit 4), in participants with PMR-AS <10, a gradual weekly glucocorticoid taper is initiated, decreasing by 2.5 mg/week until a dose of 5 mg/day is reached, followed by reductions of 1.25 mg/week until complete discontinuation of glucocorticoids. If complete discontinuation is not feasible at a dose of 5 mg/day or lower, tapering may be paused based on the investigator's clinical judgment
Participants who do not enter an open-label extension study after completion of the 16-week double-blind treatment period enter a 22-week safety follow-up (SFU) period. During follow-up, participants attend clinic visits at 2, 10, and 22 weeks after the end-of-treatment (EOT) visit for SFU assessments. The total duration of the study for participants is approximately 42 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olokizumab | Experimental | Biological: OlokizumabOlokizumab 64 mg every 2 weeks, administered as a single 0.4 mL subcutaneous injection |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo every 2 weeks, administered as a single 0.4 mL subcutaneous injection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Presence of written informed consent (IC) signed by the participant
- Confirmed diagnosis of polymyalgia rheumatica (PMR) according to the 2012 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria
- At the time of randomization, participants must meet one of the following conditions:
- PMR flare within 3 days prior to randomization meeting the following criteria:
Key exclusion criteria (54 listed)
- Presence of cranial symptoms of giant cell arteritis (GCA) within 12 weeks prior to screening
- Presence of concomitant fibromyalgia or neuropathic pain syndrome
- Presence of other systemic rheumatic diseases, including rheumatoid arthritis, Sjögren's syndrome, vasculitis (except GCA), dermatomyositis/polymyositis, and others
- Presence of concomitant conditions associated with chronic pain syndrome that could potentially interfere with efficacy assessments in the study
- Bilateral limitation of upper limb elevation above 90° (elevation of upper limbs [EUL] score 1) not related to active polymyalgia rheumatica (PMR)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlokizumabAlso: ArtlegiaSolution for subcutaneous injection in a prefilled syringe (1 mL) with a concentration of 160 mg/mL, administered as a 64 mg/0.4 mL dose | Biological | Olokizumab |
| Placebo0.9% Sodium Chloride solution for Injection | Drug | Placebo |
Primary outcome
Achievement of treatment response
Time frame: Up to Week 16 (visit 9)
Treatment response is defined as Polymyalgia Rheumatica Activity Score (PMR-AS) <10 and glucocorticoid (GC) dose ≤5 mg/day, or a reduction of ≥10 mg/day, or no new initiation of GC therapy (in participants not receiving GC at baseline), up to Week 16
14 secondary outcomes
Proportion of participants with Polymyalgia Rheumatica Activity Score (PMR-AS) <7 at each visit
Time frame: Up to Week 16 (visit 9)
Proportion of participants with Polymyalgia Rheumatica Activity Score (PMR-AS) <10 at each visit
Time frame: Up to Week 16 (visit 9)
Change in Polymyalgia Rheumatica Activity Score (PMR-AS) over the treatment period compared with baseline
Time frame: Baseline and Week 16 (visit 9)
Change from baseline in pain assessed using a visual analogue scale (VASpain)
Time frame: Baseline and Week 16 (visit 9)
Change from baseline in duration of morning stiffness
Time frame: Baseline and Week 16 (visit 9)
Change from baseline in upper limb elevation score
Time frame: Baseline and Week 16 (visit 9)
Change from baseline in investigator-assessed disease activity
Time frame: Baseline and Week 16 (visit 9)
Proportion of participants with new initiation or dose increase of glucocorticoids
Time frame: Baseline and Week 16 (visit 9)
Change in proportion of participants receiving glucocorticoids over time
Time frame: Baseline and Week 16 (visit 9)
Change from baseline in mean glucocorticoid dose
Time frame: Baseline and Week 16 (visit 9)
Cumulative glucocorticoid dose
Time frame: Baseline and Week 16 (visit 9)
Change from baseline in C-reactive protein (CRP) levels
Time frame: Baseline and Week 16 (visit 9)
Change from baseline in erythrocyte sedimentation rate (ESR)
Time frame: Baseline and Week 16 (visit 9)
Change from baseline in patient global assessment of disease activity
Time frame: Baseline and Week 16 (visit 9)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail Samsonov study director
R-Pharm
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olokizumab in people with Polymyalgia Rheumatica, run by R-Pharm International, LLC at 20 sites in Russia.
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 54 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: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Achievement of treatment response (time frame: Up to Week 16 (visit 9)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2026.