An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis

NCT03390101 | Completed Phase 3 Results

• 1 other identifier: BCD-085-7
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

BCD-085 is an innovative drug, a monoclonal antibody against interleukin-17. The toxicity, safety, and pharmacokinetics of BCD-085 were investigated in animals, in phase I clinical study in healthy volunteers, and in phase III clinical study in patients with moderate to severe plaque psoriasis. This clinical study aims at investigating the efficacy and safety of BCD-085 every other week regimen (after induction for the first 3 weeks) versus BCD-085 one per month regimen (after induction for first 3 weeks) versus placebo in patients with moderate to severe plaque psoriasis. Study purpose: To investigate the efficacy and safety of BCD-085 versus placebo in patients with moderate to severe plaque psoriasis (psoriasis vulgaris) Study objectives:

1. 1.To compare the efficacy of BCD-085 every 2 weeks versus BCD-085 every 4 weeks versus placebo, based on the proportion of patients who achieved a PASI75, target sPGA score, and on other secondary efficacy measures.
2. 2.To evaluate the proportion of patients in each study arm who develop adverse events with multiple injections of BCD-085 and placebo. Compare the safety profiles of BCD-085 when used every 4 weeks and when used every 2 weeks.
3. 3.4\. To assess the immunogenicity of BCD-085 defined as the proportion of patients who develop anti-drug antibodies (binding or neutralizing).

Conditions

Moderate to Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• • The Proportion (Number) of Patients in Each Study Arm Who Achieved a PASI 75 at Week 12 of Treatment

  The Psoriasis Area and Severity Index (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) PASI 75 indicates a 75% or greater reduction in PASI scores from baseline and is indicative of excellent disease improvement.

  week 12

Study Arms (3)

BCD-085 Q2W

EXPERIMENTAL

Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 1 will be given BCD-085 every 4 weeks through Week 50.

Drug: BCD-085 Q2W

BCD-085 Q4W

EXPERIMENTAL

Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 6 and Day 1 of Week 10. For the purpose of blind design, patients will receive a placebo (2 injections) on day 1 of week 4 and week 8. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will continue BCD-085 every 4 weeks through Week 50.

Drug: BCD-085 Q4W

Placebo

PLACEBO COMPARATOR

Patients in this arm (43 subjects) will be given two SC injections of placebo (1.0 mL each) on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2, Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 on Day 1 of Week 12, Day 1 of Week 13, Day 1 of Week 14 (induction), then every 4 weeks through Week 50.

Drug: Placebo

Interventions

BCD-085 Q2W DRUG

In Arm 1, the test drug BCD-085 will be used at a dose of 120 mg given as two SC injections according to the following schedule: once a week for the first 3 weeks (induction treatment) and then once every 2 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label patients will receive BCD-085 through week 50. The follow-up will continue through week 54.

Also known as: BCD-085

BCD-085 Q2W

BCD-085 Q4W DRUG

In Arm 2, and then once every 4 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will be given BCD-085 once every 4 weeks through week 50. The follow-up will continue through week 54.

Also known as: BCD-085

BCD-085 Q4W

Placebo DRUG

In Arm 3, patients will be given two SC injections of placebo (1.0 mL each) according to the following schedule: on Day 1 of weeks 0, 1, 2 and then once every 2 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 at weeks 12, 13, 14 and then once every 4 weeks through week 50. The follow-up will continue through week 54.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must give a written and signed informed consent.
• Men or women at least 18 years old at the time of signing the ICF
• Moderate to severe plaque psoriasis diagnosed at least 6 months before signing the informed consent form.
• Patients received at least one course of phototherapy or systemic therapy for psoriasis or are candidates for such treatment according to the investigator.
• Body surface area (BSA) affected by psoriasis of 10% or greater, the PASI score of 10 or greater, and the sPGA score of 3 or greater at screening.
• Negative pregnancy urine test in female subjects (no test is required in women who are post-menopausal for at least 2 years and in surgically sterile women).
• The patient must be able to follow the Protocol procedures (in the investigator's opinion).
• Patients of childbearing potential and their partners with preserved reproductive function must implement reliable contraceptive methods starting from signing informed consent to 20 weeks after the last dose of the study therapy. This requirement does not apply to the patients after surgical sterilization and to females who are post-menopausal for 2 years or longer. Reliable contraception methods suggest using one barrier method in combination with one of the following: spermicides, intrauterine device/oral contraceptives

You may not qualify if:

• Baseline erythrodermic, pustular, and guttate psoriasis or any other skin diseases (e.g. eczema) that can affect/complicate assessment of psoriasis treatment
• Use of the following medications:
• Prior use of monoclonal antibodies targeting IL17 or its receptor
• Prior use of more than one drug containing monoclonal antibodies or their fragments
• Prior use of monoclonal antibodies within 12 weeks before signing the informed consent.
• Any systemic medications for psoriasis (including glucocorticoids, methotrexate, sulfasalazine, cyclosporine, acitretin, mycophenolate mofetil, аpremilast, calcitriol derivatives, etc.) used within 4 weeks before signing the ICF If prior systemic therapy with non-biologics was stopped due to any reasons, the screening period can be extended up to 8 weeks during which no new non-biologics are allowed.
• Use of phototherapy within 4 weeks before signing the ICF
• Topical medications for psoriasis used within 2 weeks before signing the ICF
• Vaccination with live or attenuated vaccines within 8 weeks before signing the ICF
• Any active systemic infection or recurrent infection at screening/randomization
• HIV, hepatitis B, hepatitis C, or syphilis
• Blood biochemistry abnormalities appearing as:
• baseline creatinine \> 2 × ULN
• baseline ALT, AST or alkaline phosphatase \> 2.5 × ULN
• baseline bilirubin \> 1.5 × ULN

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

BIOCAD

Saint Petersburg, Strelna, 198515, Russia

Location

Related Publications (1)

• Puig L, Bakulev AL, Kokhan MM, Samtsov AV, Khairutdinov VR, Morozova MA, Zolkin NA, Kuryshev IV, Petrov AN, Artemeva AV, Zinkina-Orikhan AV. Efficacy and Safety of Netakimab, A Novel Anti-IL-17 Monoclonal Antibody, in Patients with Moderate to Severe Plaque Psoriasis. Results of A 54-Week Randomized Double-Blind Placebo-Controlled PLANETA Clinical Trial. Dermatol Ther (Heidelb). 2021 Aug;11(4):1319-1332. doi: 10.1007/s13555-021-00554-4. Epub 2021 May 31.

  PMID: 34060012 RESULT

Results Point of Contact

• Title: Nikiforova Aleksandra
• Organization: BIOCAD

nikiforovaan@biocad.ru

+7(812) 380 49 33

Study Officials

• Roman Ivanov, PhD

  Vice-president, R&D, International business development BIOCAD

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 4, 2018
• Study Start: December 26, 2017
• Primary Completion: July 30, 2018
• Study Completion: January 20, 2022
• Last Updated: June 1, 2022
• Results First Posted: May 11, 2021

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)