History of Changes for Study: NCT05510063

Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis

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Study Record Versions

Version	Submitted Date	Changes
1	August 19, 2022	None (earliest Version on record)
2	August 25, 2022	Sponsor/Collaborators and Study Status
3	October 30, 2022	Recruitment Status, Study Status and Contacts/Locations
4	April 26, 2023	Study Status
5	May 23, 2023	Recruitment Status, Study Status, Study Design and Study Description

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	SB5-4001
Brief Title:	Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official Title:	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
Secondary IDs:

Study Status


Record Verification:	August 2022
Overall Status:	Recruiting
Study Start:	August 4, 2022
Primary Completion:	August 2023 [Anticipated]
Study Completion:	September 2023 [Anticipated]

First Submitted:	August 19, 2022
First Submitted that Met QC Criteria:	August 19, 2022
First Posted:	August 22, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	August 19, 2022
Last Update Posted:	August 22, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Samsung Bioepis Co., Ltd.
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:

Study Description

Brief Summary:

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

Detailed 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.

Conditions


Conditions:	Plaque Psoriasis
Keywords:	Psoriasis Adalimumab

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 4
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	366 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Switched between Humira and SB5 All subjects will receive an initial dose of Humira 80 mg at Week 0, followed by Humira 40 mg every other week starting one week after the initial dose up to Week 11. From Week 13, the subjects will switch between Humira and SB5 up to Week 23.	Drug: Humira (Adalimumab) Subcutaneous (SC) injection Drug: SB5 (Adalimumab Biosimilar) Subcutaneous (SC) injection
Active Comparator: Continued on Humira All subjects will receive an initial dose of Humira 80 mg at Week 0, followed by Humira 40 mg every other week starting one week after the initial dose up to Week 23.	Drug: Humira (Adalimumab) Subcutaneous (SC) injection

Outcome Measures


Primary Outcome Measures:
1.	Area under the concentration-time curve over the dosing interval (AUCtau) [ Time Frame: Week 23 to Week 25 ]
2.	Maximum serum concentration during the dosing interval (Cmax) [ Time Frame: Week 23 to Week 25 ]

Eligibility


Minimum Age:	18 Years
Maximum Age:	80 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Have no history of Adalimumab and cell-depleting biologics Have no history of any other biologics use within 6 months prior to Week 0 Have plaque psoriasis diagnosed at least 6 months, with or without psoriatic arthritis Have plaque psoriasis with the involvement and severity of total affected BSA ≥ 10%, PASI score of ≥ 12 and PGA score of ≥ 3 (moderate) Considered to be a candidate for phototherapy or systemic therapy for psoriasis Adequate hematological, renal, and hepatic function by central lab Non-childbearing potential female, or childbearing potential female subjects or male subjects with their partners who agree to use at least two forms of appropriate contraception method from Screening until 5 months after the last dose of IP Exclusion Criteria: Have nonplaque forms of psoriasis, including erythrodermic, pustular, guttate, or drug-induced psoriasis Have other skin disease than psoriasis that requires topical, phototherapy or systemic therapy Known allergic reactions or hypersensitivity to adalimumab or to any ingredients of SB5 or Humira Have received phototherapy or conventional systemic therapy within 4 weeks prior to Week 0 Have received topical therapy for psoriasis within 2 weeks prior to Week 0, however class 6/7 corticosteroids are allowed on face and groin Women who are pregnant or nursing at Screening, or men and women planning pregnancy during the study period and until 5 months after the last dose of IP Have received a live or live attenuated viral vaccine or a live bacterial vaccine within 8 weeks prior to Week 0. Non-live COVID-19 vaccines are allowed Have active or latent tuberculosis History of ongoing infection or a positive test of HBV, HCV, or HIV infection History of sepsis, chronic or recurrent infection History of lymphoproliferative disease or leukaemia History of malignancy within the last 5 years

Contacts/Locations


Central Contact Person:	Samsung Bioepis Telephone: +82 32 728 0371 Email: sbregistry@samsung.com
Locations:	Lithuania
	SB Investigative Site [Recruiting] Kaunas, Lithuania
	SB Investigative Site [Recruiting] Vilnius, Lithuania
	Poland
	SB Investigative Site [Recruiting] Białystok, Poland
	SB Investigative Site [Recruiting] Bydgoszcz, Poland
	SB Investigative Site [Recruiting] Gdańsk, Poland
	SB Investigative Site [Recruiting] Gdynia, Poland
	SB Investigative Site [Recruiting] Kraków, Poland
	SB Investigative Site [Recruiting] Lublin, Poland
	SB Investigative Site [Recruiting] Nowa Sól, Poland
	SB Investigative Site [Recruiting] Olsztyn, Poland
	SB Investigative Site [Recruiting] Osielsko, Poland
	SB Investigative Site [Recruiting] Poznań, Poland
	SB Investigative Site [Recruiting] Siedlce, Poland
	SB Investigative Site [Recruiting] Szczecin, Poland
	SB Investigative Site [Recruiting] Warszawa, Poland
	SB Investigative Site [Recruiting] Łódź, Poland
	SB Investigative Site [Recruiting] Świdnik, Poland

IPDSharing


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References


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