NCT04930042

Efficacy, Safety, and Immunogenicity of AVT04 With Moderate-to-Severe Chronic Plaque Psoriasis

A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Ustekinumab (AVT04) and Stelara® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 581 (actual)
• Sponsor: Alvotech Swiss AG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Safety and Efficacy study of AVT04 (Alvotech Biosimilar to Ustekinumab), in patients with moderate to severe plaque psoriasis

Detailed description

AVT04 is a fully human immunoglobulin class G1κ monoclonal antibody that specifically binds to the shared p40 protein subunit of IL-12 and IL-23 and therefore inhibits their activites AVT04 is being developed to be a biosimilar with the European Union (EU)-licensed drug Stelara® (hereafter referred to as Stelara) ustekinumab, Anatomical Therapeutic Chemical code: L04AC05) injection for subcutaneous (SC) and intravenous use. Stelara is an anti-IL-12 and anti-IL-23 monoclonal antibody approved for various indications. Indications approved in the EU11 and United States (US)12 include: PsO in adult and pediatric patients, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Indications approved in the People's Republic of China include PsO and Crohn's disease.13 Approval status may differ in other geographic regions. This is a multicenter, double-blind, randomized, active control clinical study to compare the efficacy, safety, and immunogenicity of AVT04 versus Stelara in patients with moderate to severe chronic PsO. The active period of Study AVT04-GL-301 comprises 2 stages: * Stage 1: Primary Efficacy Assessment (Day 1 to Week 15) * Stage 2: Long Term Efficacy and Safety Assessment (Week 16 to 52) Stage 1 On Day 1, after successfully completing Screening activities, eligible patients will be randomized into Groups 1 and 2, in a 1:2 ratio (AVT04:Stelara), and begin Stage 1. Patient randomization will be stratified by presence or absence of previous biologic treatment, by region; ie, Europe or China, and by body weight category (≤80 kg vs \>80 kg). * Group 1: Patients will receive an initial dose of AVT04 45 mg administered SC, followed by 45 mg 4 weeks later. * Group 2: Patients will receive an initial loading dose of Stelara, 45 mg administered SC, followed by 45 mg 4 weeks later. Stage 2 At Week 16: Patients who were initially randomized in Group 1 (AVT04) will continue to receive AVT04 45 mg SC every 12 weeks at Weeks 16, 28, and 40 (unless withdrawn from the study). Patients who were initially randomized in Group 2 (Stelara) will be re-randomized into Groups 2A and 2B, in a 1:1 ratio: * Group 2A: Patients will begin receiving AVT04 45 mg SC every 12 weeks, at Weeks 16, 28, and 40 (unless withdrawn from the study). * Group 2B: Patients will continue to receive Stelara 45 mg SC every 12 weeks, at Weeks 16, 28, and 40 (unless withdrawn from the study). At Week 28: * Non-responsive patients (PASI improvement \<50% compared to BL) will be encouraged to continue in the study for safety analyses, per the Schedule of Assessments (SoA) (Table 7.1), but will not receive further study drug. * Responsive patients (PASI improvement ≥50% compared to BL) will continue in the study. At Week 40: All patients who are still in the study (except Week 28 non-responsive patients) will receive the final study drug administration. At Week 52 (EoS/ET): All patients will undergo final efficacy and safety assessment.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Stelara	AVT04 or Stelara (45 mg/5ml) will be administered as a subcutaneous injection in the thigh or abdomen per the approved dosing regimen for moderate to severe chronic PsO for patients with a body weight ≤100 kg.11,12
DRUG	AVT04	AVT04 or Stelara (45 mg/5ml) will be administered as a subcutaneous injection in the thigh or abdomen per the approved dosing regimen for moderate to severe chronic PsO for patients with a body weight ≤100 kg.11,12

Timeline

• Start date: 2021-06-03
• Primary completion: 2021-12-28
• Completion: 2022-10-11
• First posted: 2021-06-18
• Last updated: 2023-02-02

Locations

30 sites across 4 countries: Estonia, Georgia, Poland, Ukraine