Clinical trial NCT02762994: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: interleukin 17
monoclonal antibody
psoriasis
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2016-05-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Efficacy and safety parameters will be evaluated.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Patients With PASI 75 Response After 12 Weeks of Therapy
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy
timeFrame: Week 4, Week 8
measure: Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy
timeFrame: Week 4, Week 8, Week 12
measure: Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085
timeFrame: Week 4, Week 8, Week 12
measure: Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085
timeFrame: Week 4, Week 8, Week 12
measure: Relative Change in NAPSI Score After 12 Weeks of Therapy With BCD-085
timeFrame: Week 12
measure: Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085
timeFrame: Week 1, Week 4, Week 8, Week 12
measure: Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085
timeFrame: Week 4, Week 8, Week 12
measure: Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085
timeFrame: Week 4, Week 8, Week 12
measure: Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085
timeFrame: Week 4, Week 8, Week 12
measure: Frequency of AE/SAE
timeFrame: 14 weeks
measure: Frequency of Local Reactions
timeFrame: 14 weeks
measure: Frequency of AE/SAE Grade 4 CTCAE 4.03
timeFrame: 14 weeks
measure: Frequency of Withdrawal Due to AE/SAE
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: BIOCAD
state: Strelna
Study officials:
affiliation: JCS BIOCAD
name: Roman Ivanov, PhD
role: STUDY_CHAIR
References: