Clinical Trials Logo

Clinical Trial Summary

This is a Phase IV, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study to evaluate the pharmacokinetics, efficacy, safety, and immunogenicity of SB5 versus Humira in subjects with moderate to severe chronic plaque psoriasis.


Clinical Trial Description

The primary objective of this study is to assess the pharmacokinetic similarity in subjects with moderate to severe plaque psoriasis who switch between Humira and SB5 to those receiving Humira continuously. All entered subjects will be treated with Humira during a lead-in period of 13 weeks. At Week 13, subjects who achieved at least a 50% reduction in Psoriasis Area and Severity Index (PASI50) response will be randomized in a 1:1 ratio to either be switched between Humira and SB5 or continue on Humira. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05510063
Study type Interventional
Source Samsung Bioepis Co., Ltd.
Contact
Status Completed
Phase Phase 4
Start date August 4, 2022
Completion date May 4, 2023

See also
  Status Clinical Trial Phase
Completed NCT01194219 - Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis Phase 3
Recruiting NCT06030076 - A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis
Completed NCT04263610 - Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy Phase 4
Completed NCT02601469 - Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis Phase 2
Completed NCT05600036 - A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis Phase 2
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03614078 - A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis Phase 2
Not yet recruiting NCT05036889 - A 16-week Randomized Evaluation of the Impact of Mind.Px Application on Response to Biologic Treatment in Patients Suffering From Plaque Psoriasis Through Clinical Utility and Health Outcomes. N/A
Completed NCT04603027 - A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis Phase 2
Completed NCT03638258 - The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis Phase 2
Completed NCT02881346 - Efficacy and Tolerability of Enstilar® in Daily Practice
Recruiting NCT02611349 - Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis Phase 3
Completed NCT02251678 - Evaluate the Effect of Elimune Capsules Phase 1
Completed NCT01987843 - Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 2
Terminated NCT01708629 - Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects Phase 3
Completed NCT01230138 - Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis Phase 2
Withdrawn NCT00747032 - To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis Phase 3
Completed NCT00581100 - Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis Phase 4
Suspended NCT01228656 - Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate Phase 2
Completed NCT00540618 - A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis Phase 2