Efficacy and Safety of Olokizumab in Patients With Polymyalgia Rheumatica (PROMISE)

NCT07670546 | Active Not Recruiting Phase 3

• 1 other identifier: CL04041376
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 20

Brief 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). 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

Conditions

Polymyalgia Rheumatica

Keywords

Polymyalgia Rheumatica; Olokizumab; Artlegia

Outcome Measures

Primary Outcomes (1)

• 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

  Up to Week 16 (visit 9)

Secondary Outcomes (14)

• Proportion of participants with Polymyalgia Rheumatica Activity Score (PMR-AS) <7 at each visit

  Up to Week 16 (visit 9)

• Proportion of participants with Polymyalgia Rheumatica Activity Score (PMR-AS) <10 at each visit

  Up to Week 16 (visit 9)

• Change in Polymyalgia Rheumatica Activity Score (PMR-AS) over the treatment period compared with baseline

  Baseline and Week 16 (visit 9)

• Change from baseline in pain assessed using a visual analogue scale (VASpain)

  Baseline and Week 16 (visit 9)

• Change from baseline in duration of morning stiffness

  Baseline and Week 16 (visit 9)

Other Outcomes (21)

• Change from baseline in Polymyalgia Rheumatica Activity Score (PMR-AS) in subgroups of participants receiving or not receiving glucocorticoids at baseline

  Baseline and Week 16 (visit 9)

• Change from baseline in interleukin-6 (IL-6) levels

  Baseline and Week 16 (visit 9)

• Change from baseline in soluble interleukin-6 (IL-6) receptor levels

  Baseline and Week 16 (visit 9)

Study Arms (2)

Olokizumab

EXPERIMENTAL

Olokizumab 64 mg every 2 weeks, administered as a single 0.4 mL subcutaneous injection

Biological: Olokizumab

Placebo

PLACEBO COMPARATOR

Placebo every 2 weeks, administered as a single 0.4 mL subcutaneous injection

Drug: Placebo

Interventions

Olokizumab BIOLOGICAL

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

Olokizumab

Placebo DRUG

0.9% Sodium Chloride solution for Injection

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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;

Sponsors & Collaborators

• R-Pharm International, LLC: lead

Study Sites (20)

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

Izhevsk, 426009, Russia

Location

Family Polyclinic No. 4 LLC

Korolyov, 141060, Russia

Location

A.S. Loginov Moscow Clinical Scientific Center

Moscow, 111123, Russia

Location

V.A. Nasonova Research Institute of Rheumatology

Moscow, 115522, Russia

Location

I.M. Sechenov First Moscow State Medical University, Center for Clinical Studies of Medicinal Products

Moscow, 119435, Russia

Location

M.F. Vladimirsky Moscow Regional Research and Clinical Institute (MONIKI)

Moscow, 129110, Russia

Location

Russian Gerontology Research and Clinical Center, Pirogov Russian National Research Medical University

Moscow, 129226, Russia

Location

N.A. Semashko Nizhny Novgorod Regional Clinical Hospital

Nizhny Novgorod, 603126, Russia

Location

Healthy Family Medical Center LLC

Novosibirsk, 630099, Russia

Location

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, Russia

Location

Omsk Regional Clinical Hospital

Omsk, 644012, Russia

Location

Academician I.P. Pavlov Ryazan State Medical University

Ryazan, 390026, Russia

Location

Interleukin LLC

Saint Petersburg, 194214, Russia

Location

Medical and Sanitary Unit No. 157 LLC

Saint Petersburg, 196066, Russia

Location

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

Smolensk, 214025, Russia

Location

Siberian State Medical University, Ministry of Health of the Russian Federation

Tomsk, 634050, Russia

Location

State Budgetary Healthcare Institution Republican Clinical Hospital named after G.G. Kuvatov

Ufa, 450005, Russia

Location

Biomed LLC

Vladimir, 600005, Russia

Location

Yaroslavl Central City Hospital

Yaroslavl, 150047, Russia

Location

Center for Medical Consultations and Research - PRAKTIKA LLC

Yaroslavl, 150054, Russia

Location

MeSH Terms

Conditions

Polymyalgia Rheumatica

Interventions

olokizumab

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mikhail Samsonov

  R-Pharm

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized participants receive study treatment from unblinded clinical staff
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 26, 2026
• Study Start: June 11, 2025
• Primary Completion: April 10, 2026
• Study Completion: July 9, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

RU (20)