A Phase 3 interventional study of Olokizumab and Placebo in Polymyalgia Rheumatica, sponsored by R-Pharm International, LLC. Active, not recruiting at 20 sites in Russia. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by R-Pharm International, LLC (part of R-Pharm) · Phase 3, Interventional, and Treatment
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
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:
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
68 studies on the registry are indexed under Polymyalgia Rheumatica; 22 are open to participants now.
This study's enrollment of 125 is above the median of 66 across 39 interventional studies indexed under Polymyalgia Rheumatica.
Browse Polymyalgia Rheumatica studies →R-Pharm International, LLC is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Use of the following medications prior to screening:
Screening laboratory abnormalities including:
Screening evidence of virus (HBV) and/or virus (HCV) infection:
Participants with the following cardiovascular diseases:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Olokizumab 64 mg every 2 weeks, administered as a single 0.4 mL subcutaneous injection
Biological: Olokizumab
Placebo every 2 weeks, administered as a single 0.4 mL subcutaneous injection
Drug: Placebo
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
Also known as: Artlegia
0.9% Sodium Chloride solution for Injection
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
Time frame: Up to Week 16 (visit 9)
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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and Week 16 (visit 9)
Cumulative glucocorticoid dose
Total cumulative glucocorticoid dose during the treatment period
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and Week 16 (visit 9)
Change from baseline in Polymyalgia Rheumatica Activity Score (PMR-AS) in subgroups of participants receiving or not receiving glucocorticoids at baseline
Change from baseline in Polymyalgia Rheumatica Activity Score (PMR-AS) in subgroups of participants receiving or not receiving glucocorticoids at baseline
Time frame: Baseline and Week 16 (visit 9)
Change from baseline in interleukin-6 (IL-6) levels
Change from baseline in serum interleukin-6 (IL-6) levels during the treatment period
Time frame: Baseline and Week 16 (visit 9)
Change from baseline in soluble interleukin-6 (IL-6) receptor levels
Change from baseline in soluble interleukin-6 receptor levels during the treatment period
Time frame: Baseline and Week 16 (visit 9)
Change from baseline in matrix metalloproteinase-3 (MMP-3) levels
Change from baseline in serum matrix metalloproteinase-3 (MMP-3) levels during the treatment period
Time frame: Baseline and Week 16 (visit 9)
Change from baseline in serum ferritin levels
Change from baseline in serum ferritin levels during the treatment period
Time frame: Baseline and Week 16 (visit 9)
Change from baseline in bone metabolism biomarkers
Bone metabolism biomarkers include bone-specific alkaline phosphatase, osteocalcin, procollagen type I N-terminal propeptide (P1NP), and C-terminal telopeptide of type I collagen (β-CrossLaps) during the treatment period
Time frame: Baseline and Week 16 (visit 9)
Change from baseline in SF-36v1 score
Change from baseline in SF-36 version 1 health survey scores during the treatment period
Time frame: Baseline and Week 16 (visit 9)
Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) score
Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) score during the treatment period
Time frame: Baseline and Week 16 (visit 9)
Change in glucocorticoid-related toxicity parameters
Change in parameters characterizing glucocorticoid-related toxicity during the treatment period
Time frame: Baseline and Week 16 (visit 9)
Proportion of participants with cranial symptoms of giant cell arteritis
Proportion of participants with cranial symptoms of giant cell arteritis during the treatment period
Time frame: Baseline and Week 16 (visit 9)
Mean plasma trough concentrations (Ctrough) of olokizumab (OKZ)
Mean plasma trough concentrations (Ctrough) of olokizumab (OKZ) in participants with Polymyalgia Rheumatica (PMR) prior to dosing during the treatment period
Time frame: Pre-dose at each visit up to Week 16 (visit 9) and at Week 26
Time to steady-state concentration of olokizumab (OKZ)
Time to steady-state concentration of olokizumab (OKZ)
Time frame: Pre-dose at each visit up to Week 16 (visit 9) and at Week 26
Proportion of participants with laboratory abnormalities
Laboratory assessments include: * Blood test for inflammatory markers (C-reactive protein, Erythrocyte Sedimentation Rate, ferritin) * Blood test for bone metabolism markers (bone-specific alkaline phosphatase (bone ALP), osteocalcin, procollagen type I N-terminal propeptide (P1NP), C-terminal telopeptide of type I collagen (β-CrossLaps), matrix metalloproteinase-3 (MMP-3)) * Blood test for cytokine levels (IL-6, IL-6R)
Time frame: Baseline and Week 38
Proportion of participants with vital sign abnormalities
Vital signs include systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature
Time frame: Baseline and Week 38
Proportion of participants with physical examination abnormalities
Physical examination includes skin, heart, lungs, abdomen, liver, spleen, ENT organs, lymph nodes
Time frame: Baseline and Week 38
Incidence of anti-drug antibodies (ADA) to olokizumab (OKZ)
Incidence of anti-drug antibodies (ADA) to olokizumab (OKZ)
Time frame: Up to Week 26
Incidence of neutralizing antibodies (nAb) to olokizumab (OKZ)
Incidence of neutralizing antibodies (nAb) to olokizumab (OKZ)
Time frame: Up to Week 26
Titers of anti-drug antibodies (ADA) to olokizumab (OKZ)
Titers of anti-drug antibodies (ADA) to olokizumab (OKZ)
Time frame: Up to Week 26
Duration of neutralizing antibody (nAb) persistence
Duration of neutralizing antibody (nAb) persistence
Time frame: Up to Week 26
Proportion of participants discontinuing treatment due to adverse events
Safety assessments are conducted from first dose through safety follow-up 3 (SFU3). The end-of-study follow-up includes three SFU visits (SFU1-SFU3). Timing of SFU1 varies depending on treatment completion status: SFU1 occurs at the end-of-treatment (EOT) visit for participants completing the protocol treatment period, or approximately 14 days after early treatment discontinuation. SFU2 and SFU3 occur at approximately 70 and 154 days after EOT visit, respectively
Time frame: Up to Week 38
Character, frequency, severity and outcome of adverse events (AEs), including serious adverse events (SAEs)
Safety assessments are conducted from first dose through safety follow-up 3 (SFU3). The end-of-study follow-up includes three SFU visits (SFU1-SFU3). Timing of SFU1 varies depending on treatment completion status: SFU1 occurs at the end-of-treatment (EOT) visit for participants completing the protocol treatment period, or approximately 14 days after early treatment discontinuation. SFU2 and SFU3 occur at approximately 70 and 154 days after EOT visit, respectively Adverse event severity is graded 1-5 (mild, moderate, severe, life-threatening, death) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time frame: Up to Week 38
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Olokizumab