Phase 2
Completed N=120
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
Source: ClinicalTrials.gov NCT02762994 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Number of Patients With PASI 75 Response After 12 Weeks of Therapy — 24; 25; 26; 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With PASI 75 Response After 12 Weeks of Therapy |
24; 25; 26; 6 | — |
| SECONDARY Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy |
9; 10; 9; 2; 22; 19 | — |
| SECONDARY Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy |
19; 22; 16; 4; 29; 27 | — |
| SECONDARY Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085 |
61.309; 58.855; 59.524; 26.277; 82.148; 78.883 | — |
| SECONDARY Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085 |
43.046; 45.610; 39.948; 13.692; 70.479; 67.233 | — |
| SECONDARY Relative Change in NAPSI Score After 12 Weeks of Therapy With BCD-085 |
25.204; 47.095; 66.370; 7.828 | — |
| SECONDARY Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085 |
-19.600; -25.367; -26.071; -14.269; -34.767; -33.700 | — |
| SECONDARY Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085 |
10; 11; 8; 2; 21; 19 | — |
| SECONDARY Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085 |
3.740; 1.957; 6.943; 2.923; 4.763; 3.647 | — |
| SECONDARY Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085 |
-9.833; -9.000; -8.143; -4.308; -11.967; -11.133 | — |
| SECONDARY Frequency of AE/SAE |
14; 11; 7; 11; 6; 3 | — |
| SECONDARY Frequency of Local Reactions |
1; 0; 0; 0 | — |
| SECONDARY Frequency of AE/SAE Grade 4 CTCAE 4.03 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Frequency of Withdrawal Due to AE/SAE |
0; 0; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02762994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.