# A Double-blind Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara® in Patients With Moderate-to-Severe Plaque Psoriasis

> **NCT04595409** · PHASE3 · COMPLETED · sponsor: **Bioeq GmbH** · enrollment: 392 (actual)

## Conditions studied

- Plaque Psoriasis

## Interventions

- **DRUG:** FYB202 (Proposed ustekinumab biosimilar)
- **DRUG:** Stelara® (Ustekinumab)

## Key facts

- **NCT ID:** NCT04595409
- **Lead sponsor:** Bioeq GmbH
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-11-09
- **Primary completion:** 2021-06-07
- **Final completion:** 2022-03-21
- **Target enrollment:** 392 (ACTUAL)
- **Last updated:** 2023-02-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04595409

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04595409, "A Double-blind Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara® in Patients With Moderate-to-Severe Plaque Psoriasis". Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/clinical/NCT04595409. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*