PsoriasisPhase 2NCT02762994
International Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Moderate to Severe Plaque Psoriasis
A Phase 2 study testing BCD-085 in people with Psoriasis, run by Biocad at 1 site in Russia.
Trial summary
BCD-085-2 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During BCD-085-2 trial patients with moderate to severe plaque psoriasis, in whom poor response to previous treatment including UV-therapy and biologic drugs was registered, will receive 40, 80 or 120 mg… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- 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
- 120 participants
- Where
- 1 siteRussia
- Study dates
- Jun 2016to May 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age between 18 and 65 years
- Diagnosis of plaque psoriasis with stable course of the disease during last 6 months prior to enrollment in the study.
- Patient have had at least 1 course of phototherapy or systemic therapy of psoriasis or are candidates for such treatment.
- BSA affected by psoriasis ≥ 10%, PASI score ≥ 12, sPGA score ≥ 3.
- If patient have had biologic therapy for at least 3 months, there was no positive results of such treatment or patient revealed intolerance to the drug. This therapy must be discontinued at least 12 weeks before enrollment in the study.
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- Female patients have negative urine pregnancy test.
- Patient has no history of tuberculosis.
- Patients have negative results of Diaskintest.
- Patient has no history of alcohol or drug abuse.
- Patients are able to perform all procedures planed by protocol.
- Patients are ready for contraception with reliable methods starting 2 weeks before entering the study, and up to 4 weeks after the last dose of study drug.
Who cannot join
- Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
- Previous receipt of anti-interleukin 17 drugs or anti-interleukin 17 receptor drugs.
- Prior use of two or more biologics to tumor necrosis factor alfa.
- Prior use of two or more biologics to other targets.
- Previous receipt of monoclonal antibodies if they were cancelled less that in 12 weeks before signing informed consent.
- Patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent and during screening, or in a dose less than 10 mg (recalculated to prednisolone) if it was not stable.
- Prior use of disease-modifying drugs including methotrexate, sulfasalazin and cyclosporin for up to 4 weeks before signing informed consent, if their dose was not stable for up to 4 weeks before signing informed consent and during screening Prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent.
- Prior use of phototherapy including selective phototherapy and photochemotherapy for up to 4 weeks before signing informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: International Multi-center Comparative Randomized Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Moderate to Severe Plaque Psoriasis
BCD-085-2 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During BCD-085-2 trial patients with moderate to severe plaque psoriasis, in whom poor response to previous treatment including UV-therapy and biologic drugs was registered, will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Efficacy and safety parameters will be evaluated.
- Conditions
- Psoriasis
- Being tested
- BCD-085, Placebo
- Keywords
- interleukin 17, monoclonal antibody, psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-085Drug
Also called monoclonal antibody to interleukin 17
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| BCD-085, 40 mg | Experimental | Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Receives: Drug: BCD-085 |
| BCD-085, 80 mg | Experimental | Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Receives: Drug: BCD-085 |
| BCD-085, 120 mg | Experimental | Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Receives: Drug: BCD-085 |
| Placebo | Placebo comparator | Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With PASI 75 Response After 12 Weeks of Therapy
The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI: 0 (no disease) to 72 (maximal disease). The proportion of patients with PASI 75 was defined as patients achieving 75% or more improvement at Week 12 of therapy with BCD-085 from baseline.
Measured: 12 weeks
Secondary outcomes (13)
Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy
The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI: 0 (no disease) to 72 (maximal disease). The proportion of patients with PASI 75 was defined as patients achieving 75% or more improvement from baseline.
Measured: Week 4, Week 8
Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy
The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI: 0 (no disease) to 72 (maximal disease). The proportion of patients with PASI 50 and PASI 90 was defined as patients achieving 50% or more and 90% or more improvement from baseline, respectively.
Measured: Week 4, Week 8, Week 12
Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085
The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI: 0 (no disease) to 72 (maximal disease).
Relative (percentage) change in PASI score from baseline (screening) is calculated as 100 x (baseline value - time point t value) / (baseline value)
Measured: Week 4, Week 8, Week 12
Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085
The area of skin affected by psoriasis (BSA) is estimated with the palm rule. The area of the human palm without fingers corresponds to about 1% of the body surface.
Relative (percentage) from baseline is calculated as "100 x (baseline value - time point t value) / (baseline value)". If the value decreases from baseline it means improvement.
Measured: Week 4, Week 8, Week 12
Relative Change in NAPSI Score After 12 Weeks of Therapy With BCD-085
The NAPSI is used to assign a score to each nail involved, which can vary from 0 to 8. In this study, nail involvement will be assessed only for hands, so the total index of all nails can be from 0 to 80 (only hands). A negative change from baseline indicates improvement.
Relative (percentage) change in NAPSI score from baseline (screening) is calculated as 100 x (baseline value - time point t value) / (baseline value)
Measured: Week 12
Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085
Mean change in severity of pruritus assessed by visual analog scale (from 0 (no itch) to 100 mm (unbearable itch)) after 1, 4, 8 and 12 weeks of treatment with BCD-085
Measured: Week 1, Week 4, Week 8, Week 12
Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085
The sPGA scale is used to assess the psoriatic lesions in a certain patient from 0 (clear) to 5 (very severe). Within each area, the severity is estimated by three criteria (induration, desquamation, and erythema).
Measured: Week 4, Week 8, Week 12
Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085
SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being with 2 components (physical health score [PH] and mental component score [MH]). Both scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
Measured: Week 4, Week 8, Week 12
Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085
The Dermatology Life Quality Index (DLQI) is a 10-item self-reported survey, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was assessed using a 3-point scale, where score 3 means "very much", score 2 means "a lot", score 1 - "a little", and score 0 - "not at all". If more than two questions were left unanswered, the questionnaire was considered invalid. A total score was calculated by summing the score of all items (total maximum score is 30; total minimum score is 0). The higher score representing greater health-related quality of life impairment.
The mean score change was estimated as the difference between the DLQI at baseline and at the assessed visit (the baseline score was subtracted from the visit score).
Measured: Week 4, Week 8, Week 12
Frequency of AE/SAE
Number of participants with AEs and SAEs was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.
Measured: 14 weeks
Frequency of Local Reactions
Number of participants with local reactions was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.
Measured: 14 weeks
Frequency of AE/SAE Grade 4 CTCAE 4.03
Number of participants with AEs/SAEs grade 4 CTCAE 4.03 was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.
Measured: 14 weeks
Frequency of Withdrawal Due to AE/SAE
Number of participants who withdrew due to AEs/SAEs was presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman Ivanov, PhD, Study chair, JCS BIOCAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762994
- Sponsor's protocol ID
- BCD-085-2
- Status last verified
- Feb 2021
- First submitted
- 1 Apr 2016
- Last updated
- 23 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multi-center Comparative Randomized Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02762994
- Acronym / sponsor ID
- BCD-085-2
- Conditions
- Psoriasis
- Keywords
- interleukin 17, monoclonal antibody, psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Posted 23 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BCD-085-2 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During BCD-085-2 trial patients with moderate to severe plaque psoriasis, in whom poor response to previous treatment including UV-therapy and biologic drugs was registered, will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Efficacy and safety parameters will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BCD-085, 40 mg | Experimental | Drug: BCD-085Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. |
| BCD-085, 80 mg | Experimental | Drug: BCD-085Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. |
| BCD-085, 120 mg | Experimental | Drug: BCD-085Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. |
| Placebo | Placebo comparator | Other: PlaceboPatient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent
- Age between 18 and 65 years
- Diagnosis of plaque psoriasis with stable course of the disease during last 6 months prior to enrollment in the study.
- Patient have had at least 1 course of phototherapy or systemic therapy of psoriasis or are candidates for such treatment.
- BSA affected by psoriasis ≥ 10%, PASI score ≥ 12, sPGA score ≥ 3.
Key exclusion criteria (8 listed)
- Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
- Previous receipt of anti-interleukin 17 drugs or anti-interleukin 17 receptor drugs.
- Prior use of two or more biologics to tumor necrosis factor alfa.
- Prior use of two or more biologics to other targets.
- Previous receipt of monoclonal antibodies if they were cancelled less that in 12 weeks before signing informed consent.
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: monoclonal antibody to interleukin 17 | Drug | BCD-085, 120 mg, BCD-085, 40 mg, BCD-085, 80 mg |
| Placebo | Other | Placebo |
Primary outcome
Number of Patients With PASI 75 Response After 12 Weeks of Therapy
Time frame: 12 weeks
The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI: 0 (no disease) to 72 (maximal disease). The proportion of patients with PASI 75 was defined as patients achieving 75% or more improvement at Week 12 of therapy with BCD-085 from baseline.
13 secondary outcomes
Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy
Time frame: Week 4, Week 8
Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy
Time frame: Week 4, Week 8, Week 12
Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085
Time frame: Week 4, Week 8, Week 12
Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085
Time frame: Week 4, Week 8, Week 12
Relative Change in NAPSI Score After 12 Weeks of Therapy With BCD-085
Time frame: Week 12
Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085
Time frame: Week 1, Week 4, Week 8, Week 12
Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085
Time frame: Week 4, Week 8, Week 12
Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085
Time frame: Week 4, Week 8, Week 12
Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085
Time frame: Week 4, Week 8, Week 12
Frequency of AE/SAE
Time frame: 14 weeks
Frequency of Local Reactions
Time frame: 14 weeks
Frequency of AE/SAE Grade 4 CTCAE 4.03
Time frame: 14 weeks
Frequency of Withdrawal Due to AE/SAE
Time frame: 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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
JCS BIOCAD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BCD-085 in people with Psoriasis, run by Biocad at 1 site in Russia.
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 12 inclusion and 8 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 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With PASI 75 Response After 12 Weeks of Therapy (time frame: 12 weeks). 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 23 Mar 2021.