Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 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
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. 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. 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. 4. To assess the immunogenicity of BCD-085 defined as the proportion of patients who develop anti-drug antibodies (binding or neutralizing).


Options:
A: Arm Label: Group 1: Approved q12w maintenance regimen; Type: EXPERIMENTAL; Interventions: Drug: Ustekinumab 45 mg, Drug: Ustekinumab 90 mg, Drug: Placebo | Arm Label: Group 2: Subject-tailored fixed-interval maintenance regimen; Type: EXPERIMENTAL; Interventions: Drug: Ustekinumab 45 mg, Drug: Ustekinumab 90 mg, Drug: Placebo | Intervention Type: DRUG; Name: Ustekinumab 45 mg; Assigned to Arm(s): Group 1: Approved q12w maintenance regimen, Group 2: Subject-tailored fixed-interval maintenance regimen | Intervention Type: DRUG; Name: Ustekinumab 90 mg; Assigned to Arm(s): Group 1: Approved q12w maintenance regimen, Group 2: Subject-tailored fixed-interval maintenance regimen | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Group 1: Approved q12w maintenance regimen, Group 2: Subject-tailored fixed-interval maintenance regimen
B: Arm Label: A; Type: EXPERIMENTAL; Interventions: Biological: ABT-874 | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Biological: etanercept | Arm Label: C; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: BIOLOGICAL; Name: ABT-874; Assigned to Arm(s): A | Intervention Type: BIOLOGICAL; Name: etanercept; Assigned to Arm(s): B | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): C
C: Arm Label: BCD-085 Q2W; Type: EXPERIMENTAL; Interventions: Drug: BCD-085 Q2W | Arm Label: BCD-085 Q4W; Type: EXPERIMENTAL; Interventions: Drug: BCD-085 Q4W | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: BCD-085 Q2W; Assigned to Arm(s): BCD-085 Q2W | Intervention Type: DRUG; Name: BCD-085 Q4W; Assigned to Arm(s): BCD-085 Q4W | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Investigational drug - Dose 1; Type: EXPERIMENTAL; Interventions: Drug: ACT-128800 | Arm Label: Investigational drug - Dose 2; Type: EXPERIMENTAL; Interventions: Drug: ACT-128800 | Arm Label: Matching placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: ACT-128800; Assigned to Arm(s): Investigational drug - Dose 1, Investigational drug - Dose 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Matching placebo

Answer: C