To Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis

NCT05495568 | Completed Phase 3 DMC

• 2 other identifiers: CT-P17 3.32022-002336-31
• Study Type: interventional
• Target: 367
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 3 Study to Compare Pharmacokinetics, Efficacy and Safety of CT-P17 with Humira in Patients with Moderate to Severe Chronic Plaque Psoriasis

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• To demonstrate the pharmacokinetics (PK) similarity between patients receiving Humira continuously and those who alternate between Humira and CT-P17 in terms of Area under the concentration-time curve over the dosing interval (AUCtau, 25-27)

  Week 25-27

• To demonstrate the pharmacokinetics (PK) similarity between patients receiving Humira continuously and those who alternate between Humira and CT-P17 in terms of Maximum serum concentration during the dosing interval (Cmax, 25-27)

  Week 25-27

Secondary Outcomes (8)

• To evaluate Pharmacokinetics (PK) Pharmacokinetics (PK) parameter: Time to maximum serum concentration during the dosing interval (Tmax, 25-27)

  Week 25-27

• To evaluate Pharmacokinetics (PK) Pharmacokinetics (PK) parameter: Trough concentration (Ctrough)

  up to Week 52

• To evaluate Efficacy: Mean % improvement from baseline in PASI (Psoriasis Area Severity Index) score

  up to Week 52

• To evaluate Efficacy: Proportion of patients achieving at least 50/75/90/100% improvement from baseline in PASI (PASI 50/75/90/100)

  up to Week 52

• To evaluate Efficacy: Proportion of patients with an sPGA (Static Physician's Global Assessment) score on a 5-point scale of clear (0) or almost clear (1)

  up to Week 52

Study Arms (2)

Switching CT-P17

EXPERIMENTAL

On Day 1, Week 0, patients will be enrolled in the study and receive Humira. The patients will receive initial dose of Humira (80 mg; 2 shots of 40 mg) on Day 1 and Humira (40 mg) EOW starting one week after the initial dose until Week 11. Prior to the study drug administration at Week 13, patients will be randomized to receive either CT-P17 (40 mg) or Humira (40 mg) and the CT-P17 Switching group will receive CT-P17 (40mg) at Week 13, Week 15, Week 21, Week 23 and Week 25. The Switching group will receive Humira at Week 17 and Week 19. From Week 27, patients will receiAve CT-P17 (40 mg) EOW only as open-label up to Week 49.

Biological: CT-P17; Biological: EU-approved Humira

Humira maintenance

ACTIVE COMPARATOR

On Day 1, Week 0, patients will be enrolled in the study and receive Humira. The patients will receive initial dose of Humira (80 mg; 2 shots of 40 mg) on Day 1 and Humira (40 mg) EOW starting one week after the initial dose until Week 11. Prior to the study drug administration at Week 13, patients will be randomized to receive either CT-P17 (40 mg) or Humira (40 mg) and the Humira maintenance group will receive Humira (40mg) EOW up to Week 25. From Week 27, patients will receive CT-P17 (40 mg) EOW only as open-label up to Week 49.

Biological: CT-P17; Biological: EU-approved Humira

Interventions

CT-P17 BIOLOGICAL

CT-P17 40mg will be subcutaneous administered

Humira maintenance; Switching CT-P17

EU-approved Humira BIOLOGICAL

subcutaneous administration

Humira maintenance; Switching CT-P17

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is male or female aged 18 to 75 years old, both inclusive.
• Patient has had a diagnosis of chronic plaque psoriasis for at least 24 weeks prior to the first administration of the study drug (Day 1).
• Patient has stable moderate to severe plaque psoriasis with or without psoriatic arthritis at both Screening and at the time of the first administration of the study drug (Day 1) as defined by:
• Psoriasis Area and Severity Index (PASI) score of 12 or greater and
• Static Physician's Global Assessment (sPGA) score of 3 or greater and
• Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater.
• Patient who is a candidate for systemic therapy or phototherapy.
• Patient (or legal guardian, if applicable) is informed of the full nature and purpose of the study, including possible risks and side effects, is able to cooperate with the investigator and is given ample time and opportunity to read and understand verbal and/or written instructions, and signs the written informed consent form with date prior to participation in the study.
• Female patient who is considered of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use highly effective methods of contraception consistent with local regulations during the course of the study and at least 20 weeks following discontinuation of study drug (excluding women who are not of childbearing potential). Examples include the following:
• Combined (estrogen and progestogen containing) or progestogen-only hormonal contraceptives associated with inhibition of ovulation
• Intrauterine device or intrauterine hormone-releasing system
• True abstinence, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to investigational drug, and withdrawal are not acceptable methods of contraception.
• Male patient who is sexually active with a woman of childbearing potential must agree to use the highly effective method described as above or medically acceptable methods of contraception (e.g., male or female condom AND additional hormonal or barrier method by female partner) consistent with local regulations during the study and for 20 weeks following discontinuation of study drug. If patient or their partner has been surgically sterilized for less than 24 weeks prior to the date of informed consent form (ICF), they also must agree to use method(s) of contraception as described above. Postmenopausal female patients must have experienced their last menses more than 1 year prior to the date of ICF without an alternative medical cause to be classified as not of childbearing potential.

You may not qualify if:

• Patient diagnosed with forms of psoriasis other than chronic plaque (e.g., pustular, erythrodermic or guttate psoriasis) or medication-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).
• Patient who has previously received investigational or licensed product of tumor necrosis factor (TNF) α inhibitor for any purposes.
• Patient who has prior exposure to 2 or more biologic agents considered by the investigator to affect the outcome of the study. Patient with 1 prior biologic agent which is not classified as TNF-α inhibitor (e.g., interleukin \[IL\]-17, IL-12/23, IL-23 blocker) can be enrolled after 5 half-lives prior to the first administration of the study drug (Day 1).
• Patient who has allergies to any of the excipients of study drug or materials of device or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.
• Patient who currently has, or has a history of, any of the following infections:
• A known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (active or carrier state) or syphilis. However, a patient with past hepatitis B virus and/or hepatitis C virus is allowed if resolved.
• Recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug (Day 1).
• Past or current granulomatous infections or other severe or chronic infections (such as sepsis, abscess, opportunistic infections, or invasive fungal infections such as histoplasmosis). A patient who has a past diagnosis with sufficient documentation of complete resolution of the infection can be enrolled in the study.
• Acute infection requiring oral antibiotics within 2 weeks prior to the first administration of the study drug (Day 1) or a serious infection associated with hospitalization and/or which required parenteral injection of antibiotics within 24 weeks before Day 1.
• Patient who currently has, or has a history of, any of the following TB conditions:
• Patient who has a history of TB or a current diagnosis of TB. A patient who has a previous diagnosis of active TB cannot be enrolled in the study even if there is sufficient documentation of complete resolution of active TB.
• Patient who has had exposure to a person with active TB such as first-degree family members or co-workers.
• Patient who has an indeterminate result for interferon-γ release assay (IGRA) or latent TB (defined as a positive result of IGRA with a negative examination of chest X-ray) at Screening. A patient who has a previous diagnosis of latent TB cannot be enrolled despite sufficient documentation of prophylaxis. If the result of the IGRA is indeterminate at Screening, 1 retest will be possible during the Screening period. If the repeated IGRA result is indeterminate again or positive, the patient will be excluded from the study. If the repeated IGRA result is negative, the patient can be enrolled in the study.
• Patient who has a medical condition including one or more of the following:
• Classified as Class III obesity by WHO classification (body mass index≥40 kg/m2)

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

CT-P17 3.3 investigational site

Tallinn, Estonia

Location

Related Publications (2)

• Pariser DM, Lebwohl MG, Jaworski J, Trefler J, Daniluk S, Dudek A, Baran W, Owczarek W, Brzewski P, Sikora M, Krogulec M, Kim S, Suh J, Choi E, Cha J, Lee H, Lee S, Koo JY. CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study. Dermatol Ther (Heidelb). 2025 May;15(5):1079-1092. doi: 10.1007/s13555-025-01383-5. Epub 2025 Mar 27.

  PMID: 40148673 DERIVED

• Lebwohl MG, Koo JY, Jaworski J, Trefler J, Daniluk S, Dudek A, Baran W, Owczarek W, Kolinek J, Brzewski P, Sikora M, Krogulec M, Kim S, Bae Y, Jeon D, Choi E, Cha J, Lee H, Choi S, Pariser DM. Repeated Switching Between CT-P17 and EU Reference Adalimumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Active-Controlled, Phase 3, Interchangeability Study. Adv Ther. 2025 Mar;42(3):1582-1599. doi: 10.1007/s12325-024-03100-8. Epub 2025 Feb 11.

  PMID: 39932677 DERIVED

MeSH Terms

Interventions

CT-P17

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Interchangeability study

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 10, 2022
• Study Start: November 7, 2022
• Primary Completion: August 14, 2023
• Study Completion: February 5, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-07

Locations

ES (1)