Psoriatic ArthritisPhase 3PATERANCT03598751
Clinical Study of Efficacy and Safety of BCD-085 (Monoclonal Anti-IL-17 Antibody) in Psoriatic Arthritis
A Phase 3 study testing BCD-085 in people with Psoriatic Arthritis, run by Biocad at 3 sites in 2 countries.
Trial summary
Study BCD-085-8/PATERA is a multicentre double-blind placebo-controlled Phase 3 study in patients with psoriatic arthritis (PsA). The objective of the study is to evaluate the efficacy and safety of BCD-085 comparing to placebo in patients with PsA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- BCD-085
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 25 Jul 2018to 31 Aug 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Russia2 sites
Chelyabinsk Regional Clinical hospital
Chelyabinsk
North-Western State Medical University n.a. I.I.Mechnikov
Saint Petersburg
About this study
Official title: 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 BCD-085-8/PATERA is a multicentre double-blind placebo-controlled Phase 3 study in patients with psoriatic arthritis (PsA). The objective of the study is to evaluate the efficacy and safety of BCD-085 comparing to placebo in patients with PsA.
- Conditions
- Psoriatic Arthritis
- Being tested
- BCD-085, Placebo
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-085Drug
Also called Anti-interleukin-17 Monoclonal Antibody
120 mg / 2 mL subcutaneously
PlaceboDrug
2 mL
| Study group | Role | What they receive |
|---|---|---|
| BCD-085 | Experimental | 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 Receives: Drug: BCD-085 |
| Placebo | Placebo comparator | Blinded period:
Placebo at weeks 0, 1, 2, 4, 6, 8, 10, 14
* patients who don't achieve ACR 20 at week 16 will receive BCD-085 at weeks 18 and 22
* patients who achieve ACR 20 at week 16 will continue placebo at weeks 18 and 22
Open-label period:
BCD-085 120 mg at weeks 26, 30, 34, 38, 42, 46, 50, 54 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR 20
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.
Measured: week 24
Secondary outcomes (6)
ACR 20
The percentage of patients achieved 20% improvement according to American College of Rheumatology response criteria.
Measured: Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54
ACR 50
The percentage of patients achieved 50% improvement according to American College of Rheumatology response criteria.
Measured: Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54
ACR 70
The percentage of patients achieved 70% improvement according to American College of Rheumatology response criteria.
Measured: Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54
Proportion of patients achieved PsARC (Psoriatic Arthritis Response Criteria)
Measured: Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54
Change in radiological signs of arthritis (mTSS)
mTSS - modified Total Sharp Score
Measured: Week 24 and 54
Proportion of patients with anti-drug antibodies
Measured: Week 2, Week 12, Week 24, Week 38, Week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start25 Jul 2018
- Primary completion26 Jun 2019
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman Ivanov, PhD, Study chair, Biocad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598751
- Sponsor's protocol ID
- BCD-085-8
- Acronym
- PATERA
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2018
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Multicenter Randomized Double-blind Placebo-controlled Clinical Study of the Efficacy and Safety of Subcutaneous BCD-085 in Patients With Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT03598751
- Acronym / sponsor ID
- PATERA / BCD-085-8
- Conditions
- Psoriatic Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study BCD-085-8/PATERA is a multicentre double-blind placebo-controlled Phase 3 study in patients with psoriatic arthritis (PsA). The objective of the study is to evaluate the efficacy and safety of BCD-085 comparing to placebo in patients with PsA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCD-085 | Experimental | Drug: BCD-085Blinded 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 |
| Placebo | Placebo comparator | Drug: PlaceboBlinded period: Placebo at weeks 0, 1, 2, 4, 6, 8, 10, 14 * patients who don't achieve ACR 20 at week 16 will receive BCD-085 at weeks 18 and 22 * patients who achieve ACR 20 at week 16 will continue placebo at weeks 18 and 22 Open-label period: BCD-085 120 mg at weeks 26, 30, 34, 38, 42, 46, 50, 54 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCD-085Also: Anti-interleukin-17 Monoclonal Antibody120 mg / 2 mL subcutaneously | Drug | BCD-085 |
| Placebo2 mL | Drug | Placebo |
Primary outcome
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.
6 secondary outcomes
ACR 20
Time frame: 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
ACR 70
Time frame: 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
Change in radiological signs of arthritis (mTSS)
Time frame: Week 24 and 54
Proportion of patients with anti-drug antibodies
Time frame: Week 2, Week 12, Week 24, Week 38, Week 54
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Ivanov, PhD study chair
Biocad
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BCD-085 in people with Psoriatic Arthritis, run by Biocad at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia, Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR 20 (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.