Actively Recruiting
Efficacy and Safety of Olokizumab in Patients With Progressive Fibrosing Interstitial Lung Diseases
Led by R-Pharm International, LLC · Updated on 2024-11-19
138
Participants Needed
33
Research Sites
278 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 purpose of this study is to evaluate efficacy and safety of olokizumab (OKZ) compared to placebo in patients progressive fibrosing Interstitial lung diseases (ILD).
CONDITIONS
Official 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 the Informed Consent Form
- Progressive fibrosing ILD confirmed by high-resolution computed tomography (HRCT) showing more than 10% lung tissue affected
- Diagnosed with usual interstitial pneumonia-like pattern, progressive interstitial pneumonia with autoimmune features, or progressive lung fibrosis associated with other disorders
- Evidence of disease progression based on lung function decline, worsening symptoms, or increased fibrosis area on HRCT
- Stable disease without recent changes in maintenance treatment
- ILD duration of no more than 8 years from the start of respiratory symptoms
- Elevated acute phase reactants at screening not caused by other reasons
- Forced vital capacity (FVC) between 45% and 80% predicted at screening
You will not qualify if you...
- Hemoglobin-corrected DLCO less than 30% predicted at screening
- Significant airway obstruction with FEV1/FVC ratio below 70%
- Use of interleukin-6 inhibitors or IL-6 receptor inhibitors except for COVID-19 treatment within 6 months
- Rituximab treatment within 12 months before screening
- Systemic glucocorticosteroids over 10 mg/day or recent/planned dose changes
- History of bone marrow transplantation, total lymphoid tissue irradiation, or high-dose cyclophosphamide
- Starting mycophenolate mofetil or antifibrotic agents less than 12 months before screening
- Stopping antifibrotic agents within 6 months before screening
- Participation in another clinical trial within 30 days or less than 5 half-lives of other medications
- Liver enzyme elevation, low platelet, leukocyte, or neutrophil counts
- Current or recent malignancy within 5 years
- Recent acute or severe infections requiring treatment or hospitalization
- Certain herpes zoster infections within 6 months
- Other chronic infections that increase infection risk
- Symptomatic gastrointestinal diseases that may cause perforation
- Women of child-bearing potential or men with partners of child-bearing potential not using effective contraception
- Known allergy to olokizumab or related products
- History of severe allergic reactions to monoclonal antibodies
- Other protocol-defined exclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
M
Maria Lemak
CONTACT
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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