NCT04453137

Pharmacokinetic, Efficacy, Safety, and Immunogenicity of AVT02 With Moderate to Severe Chronic Plaque Psoriasis

Multicenter, Double-Blind, Randomized, Parallel-group, Study Evaluating PK, Efficacy, Safety, and Immunogenicity in Patients With Plaque Psoriasis Receiving Humira® or AVT02 Followed by a Safety Extension Phase of AVT02

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 567 (actual)
• Sponsor: Alvotech Swiss AG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Pharmacokinetic, Efficacy, Safety, and Immunogenicity Between Patients with Moderate to Severe Chronic Plaque Psoriasis Receiving Humira® and Patients with Moderate to Severe Chronic Plaque Psoriasis

Detailed description

This is a multicenter, randomized, double-blind, parallel-group study to evaluate PK, efficacy, safety, and immunogenicity between patients with moderate to severe chronic plaque psoriasis receiving Humira and patients with moderate to severe chronic plaque psoriasis undergoing repeated switches between Humira and AVT02, followed by an optional safety Extension Phase. AVT02-GL-302 study is composed of 3 parts: LeadIn Period: Week 1-12 - OpenLabel Treatment Switching Module: Week 12-28 - DoubleBlind Treatment Optional Extension Phase: Week 28-52 - OpenLabel Treatment Lead-In Period: After successfully completing Screening activities, patients will be enrolled in the LeadIn Period. During the LeadIn Period, patients will receive Humira (initial dose of 80 mg \[2 × 40 mg\] administered subcutaneously \[SC\], followed by 40 mg SC given every other week starting 1 week after the initial dose). At Week 12, responsive patients (Psoriasis Area and Severity Index \[PASI\] ≥ 75 \[PASI75\]) will be randomly assigned in a 1:1 ratio to either of the following groups for participation in the Double-Blind Switching Module. Switching Module: Group 1: patients undergo repeated switches (Sw) of AVT02 and Humira from Week 12 until Week 26: Sw1-AVT02 (40 mg every other week) for 4 weeks (2 injections), Sw2-Humira (40 mg every other week) for 4 weeks (2 injections), Sw3-AVT02 (40 mg every other week) for 8 weeks (4 injections). Group 2: patients continue to receive Humira 40 mg every other week from Week 12 until Week 26 (8 injections) The last study treatment administration in the Double-Blind Switching Module is at Week 26. The last study assessment is at Week 28 for both groups. The end-of-study (EoS) visit for the interchangeability (IC) part of study is planned at Week 28 (ie, 2 weeks after the last study treatment administration, EoS IC). Extension Phase: At Week 28, after the EoS IC visit, responsive patients (PASI ≥ 50 \[PASI50\]) will be offered to continue with the optional open-label Extension Phase (Weeks 28 to 52). AVT02 40 mg will be administered every other week starting from Week 28 (after completing EoS IC assessments), ending with the final study drug administration at Week 50. The EoS visit is planned for Week 52. The clinical study report (CSR) for the IC part of the study will include the data from the OpenLabel Lead-In Period and Double-Blind Switching Module. The Extension Phase CSR will include the data from the additional 24-week Open-Label Extension Phase (Weeks 28 to 52).

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	Adalimumab originator	Subcutaneous injection every other week
BIOLOGICAL	Adalimumab biosimilar	Subcutaneous injection every other week

Timeline

• Start date: 2020-06-30
• Primary completion: 2021-05-31
• Completion: 2021-11-16
• First posted: 2020-07-01
• Last updated: 2022-05-04

Locations

25 sites across 5 countries: Georgia, Iceland, Poland, Russia, Ukraine