- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03598751
Clinical Study of Efficacy and Safety of BCD-085 (Monoclonal Anti-IL-17 Antibody) in Psoriatic Arthritis (PATERA)
An International Multicenter Randomized Double-blind Placebo-controlled Clinical Study of the Efficacy and Safety of Subcutaneous BCD-085 in Patients With Psoriatic Arthritis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Minsk, Belarus
- 1st City Clinical Hospital
-
-
-
-
-
Chelyabinsk, Russian Federation
- Chelyabinsk Regional Clinical Hospital
-
Saint-Petersburg, Russian Federation
- North-Western State Medical University n.a. I.I.Mechnikov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed informed consent (IC)
- History of psoriatic arthritis (According to CASPAR, 2006) for 6 months
- 3/68 TJC and 3/66 SJC
- RF / ACCP negative
- At least 1 psoriatic plaque ≥ 2 cm and/or psoriatic nails and/or history of confirmed plaque psoriasis
- History of inadequate response to NSAID
- Stable dose of NSAID for 2 weeks
- If on steroids: inadequate response to steroids (at least 3 months of treatment) and stable dose of steroids (10 mg or less) for at least 2 weeks.
- If on MTX: inadequate response to MTX (stable dose 15 - 25 mg / week for at least 2 months)
- In case of history of etanercept therapy: at least 4 weeks after last administration
- In case of history of infliximab therapy: at least 8 weeks after last administration
- In case of history of adalimumab / golimumab / certolizumab pegol therapy: at least 10 weeks after last administration
- In case of history of other mabs / fragments / small molecules : at least 5 half life after last administration
- Negative pregnancy test for women with childbearing potential
- Ability to follow procedures of the study
- Patient and his/her sexual partner with childbearing potential are ready to use reliable contraception, starting at the date of IC sign, within the study period and 4 weeks after the last dose of investigational drug administration. (Not applied to participants/sexual partners who surgically sterilized, and women at menopause for more than 2 years). Reliable contraception considered as 1 barrier method and one of the following: spermicides, oral contraception or intrauterine devices)
Exclusion Criteria:
- Therapy with anti-IL17 / IL17R or anti-IL12/23 or history of therapy with 2 or more monoclonal antibodies or therapy with topical / oral retinoids or phototherapy or other topical medication for psoriasis history or parenteral steroids administration or any intraarticular injections within 4 weeks prior IC sign or any DMARD therapy (excl. methotrexate) on the dated of IC
- Vaccination with live vaccines within 8 weeks prior to IC sign
- Diagnosis of any other chronic infection which may increase the risk of infectious adverse events.
- HIV, HCV, HBV, Syphilis.
- Clinically significant deviations in blood chemistry and blood count
- History of Herpes Zoster
- History of depression, suicidal ideation/behavior.
- Known history of alcohol or drug abuse
- Diagnosis or history of tuberculosis
- Any acute infection or chronic infection flare within 30 days prior to informed consent sign, which may increase (according to the PI opinion) the risk of infectious adverse events.
Any other documented conditions which increase the risk of AEs development or may interfere with symptoms the disease (masking, increasing or changing) or induce clinical symptoms or laboratory abnormalities similar to PsA:
- Uncontrolled diabetes mellitus;
- Severe, uncontrolled hypertension;
- Presence or history of inflammatory joint disease other than PsA (or any other systemic autoimmune disease (including lupus, Crohn's disease, ulcerative colitis, scleroderma, inflammatory myopathy, mixed connective tissue disease, autoimmune overlap syndrome, fibromyalgia etc.);
- History of malignancy, excluding cured basal cell carcinoma / cervical cancer in situ (complete remission for 5 years); cured basal cell skin carcinoma (5 years complete remission), cured ductal breast cancer (5 years complete remission);
- Decompensated liver or kidney diseases;
- Unstable angina pectoris;
- Chronic heart failure, class III-IV according to NYHA;
- Myocardial infarction, within 1 year prior to IC sign;
- History of organ transplantation;
- History of Quincke edema;
- History of any significant respiratory diseases, including COPD, asthma or bronchiectasis;
- Decompensated respiratory failure;
- History of multiple sclerosis,
- Devic's disease, or Guillain-Barre syndrome;
- Any neurological disease with motor or sensory functions impairment)
- Pregnancy, current or planned in less than 8 weeks after study completion or breastfeeding.
- Simultaneous participation in other clinical trials or participation in other clinical trials with 3 month prior to IC signing date or history of participation it current clinical study (excluding patients dropped out at screening).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: BCD-085
Blinded period: BCD-085 120 mg at weeks 0, 1, 2, 4, 6, 8, 10, 14, 18, 22 Open-label period: BCD-085 120 mg at weeks 26, 30, 34, 38, 42, 46, 50, 54 |
120 mg / 2 mL subcutaneously
Other Names:
|
PLACEBO_COMPARATOR: Placebo
Blinded period: Placebo at weeks 0, 1, 2, 4, 6, 8, 10, 14
Open-label period: BCD-085 120 mg at weeks 26, 30, 34, 38, 42, 46, 50, 54 |
2 mL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ACR 20
Time Frame: week 24
|
The percentage of patients achieved 20% improvement according to American College of Rheumatology response criteria. The ACR Criteria is a dichotomous variable with a positive (=responder) or negative (=non-responder) outcome. The ACR Criteria measures improvement in tender / swollen joint counts and improvement in at least three of the following parameters: 1) patient assessment 2) physician assessment 3) pain scale 4) disability/functional questionnaire 5) acute phase reactant (ESR or CRP). ACR 20 / 50 / 70 has a positive outcome if 20% / 50% / 70% improvement in tender and swollen joint counts was achieved as well as a 20% / 50% / 70% improvement in at least three of the other five criteria. |
week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ACR 20
Time Frame: Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54
|
The percentage of patients achieved 20% improvement according to American College of Rheumatology response criteria.
|
Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54
|
ACR 50
Time Frame: Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54
|
The percentage of patients achieved 50% improvement according to American College of Rheumatology response criteria.
|
Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54
|
ACR 70
Time Frame: Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54
|
The percentage of patients achieved 70% improvement according to American College of Rheumatology response criteria.
|
Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54
|
Proportion of patients achieved PsARC (Psoriatic Arthritis Response Criteria)
Time Frame: Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54
|
Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54
|
|
Change in radiological signs of arthritis (mTSS)
Time Frame: Week 24 and 54
|
mTSS - modified Total Sharp Score
|
Week 24 and 54
|
Proportion of patients with anti-drug antibodies
Time Frame: Week 2, Week 12, Week 24, Week 38, Week 54
|
Week 2, Week 12, Week 24, Week 38, Week 54
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCD-085-8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psoriatic Arthritis
-
AmgenRecruitingActive Juvenile Psoriatic ArthritisSpain, United Kingdom, Turkey, Belgium, France, Greece, Italy, Austria, Germany, Netherlands, Poland, Portugal, Romania, Lithuania, South Africa
-
Universitätsklinikum Hamburg-EppendorfBristol-Myers Squibb; Eli Lilly and Company; UCB Pharma; Merck Sharp & Dohme LLC; AbbVi... and other collaboratorsRecruiting
-
Sun Pharmaceutical Industries LimitedActive, not recruitingActive Psoriatic ArthritisUnited States, Australia, Czechia, Germany, India, Japan, Korea, Republic of, Poland, Spain
-
AbbVieActive, not recruitingPsoriatic Arthritis (PsA)United States, Argentina, Australia, Belgium, Brazil, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Sweden, United...
-
Sun Pharmaceutical Industries LimitedCompleted
-
Bristol-Myers SquibbCompletedActive Psoriatic ArthritisSpain, United States, Hungary, Germany, Poland, United Kingdom, Russian Federation, Italy, Czechia
-
Bristol-Myers SquibbCompletedPsoriatic Arthritis (PsA)Germany
-
Pope Research CorporationAmgenWithdrawn
-
Sun Pharmaceutical Industries LimitedRecruitingActive Psoriatic ArthritisUnited States, Australia, Czechia, Estonia, Korea, Republic of, Poland, Slovakia, Spain, Taiwan, Germany, Italy, India, Canada
-
Humanis Saglık Anonim SirketiCompletedPsoriasis and Psoriatic ArthritisIndia
Clinical Trials on BCD-085
-
BiocadCompleted
-
BiocadActive, not recruitingAnkylosing SpondylitisRussian Federation
-
BiocadTerminatedLiver Cirrhosis, BiliaryRussian Federation
-
BiocadCompleted
-
BiocadCompleted
-
Kechow Pharma, Inc.Completed
-
Shanghai Kechow Pharma, Inc.Completed
-
Idorsia Pharmaceuticals Ltd.CompletedRenal ImpairmentGermany