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

NCT05510063 | Completed Phase 4

• 1 other identifier: SB5-4001
• Study Type: interventional
• Target: 371
• Locations: 4 countries
• Sites: 23

Brief 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.

Conditions

Plaque Psoriasis

Keywords

Psoriasis; Adalimumab

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve over the dosing interval (AUCtau)

  Week 23 to Week 25

• Maximum serum concentration during the dosing interval (Cmax)

  Week 23 to Week 25

Study Arms (2)

Switched between Humira and SB5

EXPERIMENTAL

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); Drug: SB5 (Adalimumab Biosimilar)

Continued on Humira

ACTIVE COMPARATOR

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)

Interventions

Humira (Adalimumab) DRUG

Subcutaneous (SC) injection

Continued on Humira; Switched between Humira and SB5

SB5 (Adalimumab Biosimilar) DRUG

Subcutaneous (SC) injection

Switched between Humira and SB5

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead
• Organon and Co: collaborator

Study Sites (23)

SB Investigative Site

Dupnitsa, Bulgaria

Location

SB Investigative Site

Pleven, Bulgaria

Location

SB Investigative Site

Sofia, Bulgaria

Location

SB Investigative Site

Ostrava, Czechia

Location

SB Investigative Site

Pardubice, Czechia

Location

SB Investigative Site

Prague, Czechia

Location

SB Investigative Site

Kaunas, Lithuania

Location

SB Investigative Site

Vilnius, Lithuania

Location

SB Investigative Site

Bialystok, Poland

Location

SB Investigative Site

Bydgoszcz, Poland

Location

SB Investigative Site

Gdansk, Poland

Location

SB Investigative Site

Gdynia, Poland

Location

SB Investigative Site

Krakow, Poland

Location

SB Investigative Site

Lodz, Poland

Location

SB Investigative Site

Lublin, Poland

Location

SB Investigative Site

Nowa Sól, Poland

Location

SB Investigative Site

Olsztyn, Poland

Location

SB Investigative Site

Osielsko, Poland

Location

SB Investigative Site

Poznan, Poland

Location

SB Investigative Site

Siedlce, Poland

Location

SB Investigative Site

Szczecin, Poland

Location

SB Investigative Site

Świdnik, Poland

Location

SB Investigative Site

Warsaw, Poland

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 22, 2022
• Study Start: August 4, 2022
• Primary Completion: April 4, 2023
• Study Completion: May 4, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

LI (2); CZ (3); PL (15); BU (3)