Actively Recruiting
Efficacy and Safety of Olokizumab Compared to Placebo in Patients With Progressive Fibrosing Interstitial Lung Diseases A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2/3 Study
Led by R-Pharm International, LLC · Updated on 2024-11-19
138
Participants Needed
33
Research Sites
89 weeks
Total Duration
On this page
Sponsors
R
R-Pharm International, LLC
Lead Sponsor
R
R-Pharm
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates the safety and effectiveness of olokizumab compared to a placebo in adults with progressive fibrosing interstitial lung diseases (ILD). This phase 2/3 study uses a double-blind, parallel-group adaptive design to better understand treatment impacts on lung function over time. Participants have progressive fibrosing ILD confirmed by imaging and lung function tests, with disease progression documented within the prior months or years. Participants will be randomly assigned to receive either subcutaneous injections of olokizumab 64 mg or placebo every four weeks during a 48-week treatment period. The study includes a screening period lasting four weeks, followed by a treatment period of 48 weeks, and then a follow-up period of 24 weeks with visits scheduled at 4, 12, and 24 weeks post-treatment. The total duration of participation is approximately 76 weeks. Throughout the study, patients will undergo lung function tests including forced vital capacity (FVC) and diffusion capacity for carbon monoxide (DLCO), as well as imaging assessments to evaluate lung fibrosis. Researchers will monitor symptoms, lung function changes, and quality of life measures using dyspnea scores and health questionnaires. Safety will be closely observed during treatment and follow-up visits, with the main outcome focused on changes in FVC over 48 weeks.
CONDITIONS
Brief Title
Efficacy and Safety of Olokizumab in Patients With Progressive Fibrosing Interstitial Lung Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Progressive fibrosing interstitial lung disease confirmed by high-resolution CT with more than 10% lung tissue affected.
- Progressive disease shown by decrease in lung function or worsening symptoms within the past 12 to 24 months.
- ILD duration of no more than 8 years from symptom onset.
- Elevated C-reactive protein or erythrocyte sedimentation rate at screening.
- Forced vital capacity (FVC) between 45% and 80% predicted at screening.
- Stable main disease without need to change maintenance treatment.
You will not qualify if you...
- Hemoglobin-corrected DLCO less than 30% predicted at screening.
- Significant airway obstruction with FEV1/FVC ratio less than 70%.
- Use of interleukin-6 inhibitors or IL-6 receptor inhibitors within 6 months before screening (except for COVID-19 treatment).
- Rituximab treatment within 12 months prior to screening.
- Use of systemic glucocorticosteroids over 10 mg/day or recent dose changes.
- History of bone marrow transplantation or high-dose cyclophosphamide.
- Recent start or discontinuation of antifibrotic drugs within specified timeframes.
- Participation in other clinical trials within 30 days or 5 half-lives of other drugs.
- Laboratory abnormalities including elevated liver enzymes or low blood cell counts.
- Recent or active infections, malignancies within 5 years, or certain gastrointestinal diseases.
- Women or men with partners of child-bearing potential who do not agree to effective contraception.
- Known allergies to olokizumab or placebo components.
- History of severe allergic reactions to monoclonal antibodies.
- Other protocol-defined exclusion criteria apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 48 weeks
Participants receive subcutaneous injections of either Olokizumab 64 mg or placebo every 4 weeks during the double-blind treatment period.
Monthly visits for injections every 4 weeks during 48 weeks
Duration - 24 weeks
Participants attend follow-up visits to monitor safety and outcomes after completing the treatment period.
3 visits at 4, 12, and 24 weeks after treatment ends
Trial Site Locations
Total: 33 locations
1
Regional Clinical Hospital Regional state budgetary healthcare institution
Barnaul, Russia, 656024
Actively Recruiting
2
Regional Clinic Hospital№3
Chelyabinsk, Russia, 454001
Actively Recruiting
3
Chelyabinsk Regional Clinical Hospital
Chelyabinsk, Russia, 454048
Actively Recruiting
4
State budgetary healthcare institution of the Leningrad region "Gatchina Clinical Interdistrict Hospital"
Gatchina, Russia, 188300
Actively Recruiting
5
LLC" Medsi-Izhevsk"
Izhevsk, Russia, 426011,
Actively Recruiting
6
LLC "Scientific Research Medical Complex "Your Health"
Kazan', Russia, 420094
Actively Recruiting
7
Kuzbass Clinical Hospital Emergency Medical Care named after Podgorbunsky M.A
Kemerovo, Russia, 650000
Actively Recruiting
8
State Budgetary Healthcare Institution Research Institute-Karpaty Clinical Hospital No. 1 named after prof. S.V. Ochapovsky
Krasnodar, Russia, 350086
Actively Recruiting
9
City Clinical Hospital named after Davydovsky I.V.
Moscow, Russia, 109240
Actively Recruiting
10
GBUZ Moscow Clinical Scientific Center named after Loginov MHD
Moscow, Russia, 111123
Actively Recruiting
11
Scientific Research Institute of Reumatology named after Nasonova V.A
Moscow, Russia, 115522
Actively Recruiting
12
Moscow City Polyclinic №52
Moscow, Russia, 117546
Actively Recruiting
13
Clinical Hospital №4 of Sechenov University
Moscow, Russia, 119048
Actively Recruiting
14
Clinical Hospital №3 of Sechenov University
Moscow, Russia, 119435
Actively Recruiting
15
State Budgetary Healthcare Institution of Moscow City "City Clinical Hospital №52" of the Moscow City Health Department", Consultative and diagnostic department №2
Moscow, Russia, 123182
Actively Recruiting
16
State Budgetary Healthcare Institution of Moscow City "City Clinical Hospital №52" of the Moscow City Health Department"
Moscow, Russia, 123182
Actively Recruiting
17
FSBEI HE "Russian University of Medicine", MoH of Russia
Moscow, Russia, 127473
Actively Recruiting
18
Moscow Regional Research and Clinical Institute "MONIKI"
Moscow, Russia, 129110
Actively Recruiting
19
Federal Research Center Institute of Cytologyand Genetics,Siberian Branch of Russian Academy of Sciences
Novosibirsk, Russia, 630117
Actively Recruiting
20
Republican Hospital named after V.A. Baranov
Petrozavodsk, Russia, 185019
Actively Recruiting
21
Saint-Petersburg State Research Institute of Phthisiopulmonology of the Ministry of Healthcare of the Russian Federation
Saint Petersburg, Russia, 139036
Actively Recruiting
22
LLC"Energy of Health"
Saint Petersburg, Russia, 194156
Actively Recruiting
23
Medical Center "Interleukin"
Saint Petersburg, Russia, 194214
Actively Recruiting
24
City Multidisciplinary Hospital №2-Expert Center in the field of Pulmonology
Saint Petersburg, Russia, 194354
Actively Recruiting
25
LLC"Kurator"
Saint Petersburg, Russia, 196240,
Actively Recruiting
26
State Healthcare Institution "Regional Clinical Hospital"
Saratov, Russia, 410053
Actively Recruiting
27
Regional state budgetary healthcare institution "Clinical Hospital No. 1"
Smolensk, Russia, 214006
Actively Recruiting
28
Regional State Budgetary Healthcare Institution "Medical and Sanitary Unit No. 2
Tomsk, Russia, 634040
Actively Recruiting
29
Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
Ufa, Russia, 450008
Actively Recruiting
30
State Budgetary Healthcare Institution of the Vladimir Region "Regional Clinical Hospital"
Vladimir, Russia, 600023
Actively Recruiting
31
Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No1"
Voronezh, Russia, 394066
Actively Recruiting
32
Clinical Hospital of Emergency Medical Care named after Solovyov N.V
Yaroslavl, Russia, 150003
Actively Recruiting
33
Ural research Institute of Phthisiopulmonology
Yekaterinburg, Russia, 620039
Actively Recruiting
Research Team
Y
Yana Deloveri
M
Maria Lemak
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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