To Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis
NCT ID: NCT05495568
Last Updated: 2024-08-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
367 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-11-07
Study Completion Date
2024-02-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT05510063
Plaque Psoriasis
COMPLETED
PHASE4
A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients with Moderate to Severe Psoriasis
NCT06630559
Plaque Psoriasis
NOT_YET_RECRUITING
PHASE3
A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis
NCT05073315
Plaque Psoriasis
COMPLETED
PHASE3
Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira
NCT02016105
Plaque Type Psoriasis
COMPLETED
PHASE3
A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis
NCT04967508
Psoriasis
Moderate to Severe Plaque Psoriasis
COMPLETED
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
CT-P17 is a recombinant human monoclonal antibody containing the active ingredient adalimumab (human TNF-α blocker). CT-P17 is a drug product being developed by CELLTRION, Inc. and being compared to both the EU-approved Humira® and US-licensed Humira®. In this study, Pharmacokinetics, Efficacy and Safety of CT-P17 will be evaluated in patients with Moderate to Severe Chronic Plaque Psoriasis.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Moderate to Severe Chronic Plaque Psoriasis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Interchangeability study
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Switching CT-P17
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.
Group Type
EXPERIMENTAL
CT-P17
Intervention Type
BIOLOGICAL
CT-P17 40mg will be subcutaneous administered
EU-approved Humira
Intervention Type
BIOLOGICAL
subcutaneous administration
Humira maintenance
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.
Group Type
ACTIVE_COMPARATOR
CT-P17
Intervention Type
BIOLOGICAL
CT-P17 40mg will be subcutaneous administered
EU-approved Humira
Intervention Type
BIOLOGICAL
subcutaneous administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CT-P17
CT-P17 40mg will be subcutaneous administered
Intervention Type
BIOLOGICAL
EU-approved Humira
subcutaneous administration
Intervention Type
BIOLOGICAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Patient is male or female aged 18 to 75 years old, both inclusive.
2. 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).
3. 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.
4. Patient who is a candidate for systemic therapy or phototherapy.
5. 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.
6. 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:
1. Combined (estrogen and progestogen containing) or progestogen-only hormonal contraceptives associated with inhibition of ovulation
2. Intrauterine device or intrauterine hormone-releasing system
3. 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.
2. 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).
3. 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.
4. Patient who is a candidate for systemic therapy or phototherapy.
5. 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.
6. 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:
1. Combined (estrogen and progestogen containing) or progestogen-only hormonal contraceptives associated with inhibition of ovulation
2. Intrauterine device or intrauterine hormone-releasing system
3. 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.
Exclusion Criteria
1. 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).
2. Patient who has previously received investigational or licensed product of tumor necrosis factor (TNF) α inhibitor for any purposes.
3. 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).
4. 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.
5. Patient who currently has, or has a history of, any of the following infections:
1. 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.
2. Recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug (Day 1).
3. 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.
4. 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.
6. Patient who currently has, or has a history of, any of the following TB conditions:
1. 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.
2. Patient who has had exposure to a person with active TB such as first-degree family members or co-workers.
3. 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.
7. Patient who has a medical condition including one or more of the following:
1. Classified as Class III obesity by WHO classification (body mass index≥40 kg/m2)
2. Diabetes mellitus considered by the investigator to be clinically significant and uncontrolled, even after insulin treatment.
3. Uncontrolled hypertension (as defined by systolic blood pressure \[BP\] ≥160 mmHg or diastolic BP ≥100 mmHg).
4. Active ongoing inflammatory or autoimmune disease other than chronic plaque psoriasis and psoriatic arthritis, that may confound the evaluation of the effect of the study drug.
5. History of a known malignancy within the previous 5 years prior to the first administration of the study drug (Day 1) except completely excised and cured squamous carcinoma of the uterine cervix in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
6. New York Heart Association class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina or clinically significant electrocardiogram \[ECG\] abnormalities), or myocardial infarction within 24 weeks prior to the first administration of the study drug (Day 1).
7. History of organ transplantation, including corneal graft/transplantation.
8. Any underlying condition (e.g., metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) that, in the opinion of the investigator significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.
9. Pre-existing or recent-onset central or peripheral nervous system demyelinating disease, including multiple sclerosis, optic neuritis and Guillain-Barre syndrome.
10. Any other serious acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or study drug administration or that could interfere with the interpretation of study results.
11. History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion.
8. Patient who has the following laboratory abnormalities:
1. Hemoglobin ≤8.0 g/dL (SI \[Système International d'Unités\] units: ≤80 g/L or 4.96 mmol/L).
2. Platelet count \<75× 103 cells/µL (SI units: \<75 × 109 cells/L).
3. Absolute neutrophil count \<1.5 × 103 cells/µL (SI units: \<1.5 × 109 cells/L).
4. Alanine aminotransferase or aspartate aminotransferase \>3.0 × upper limit of normal (ULN).
5. Serum creatinine \>1.5 × ULN or an estimated creatinine clearance level ≤50 mL/min (by Cockcroft-Gault formula) (SI units: 0.84 mL/s).
9. Patient who has received or plans to receive any of following prohibited medications or treatments:
1. Topical treatment for psoriasis or any other skin condition (e.g., corticosteroids, vitamin D analogues, pimecrolimus, retinoids, salicylvaseline, salicylic acid, lactic acid, tacrolimus, tar, urea, α-hydroxy or fruit acids) within 2 weeks prior to the first administration of the study drug (Day 1). However, low-potency topical corticosteroids (Class 6 or 7) applied to the face and intertriginous areas are permitted during study participation to reduce patient's burden with a restriction of use within 12 hours prior to study visits requiring PASI or sPGA measures. Bland moisturizers/emollients not containing pharmacological active ingredients are permitted for treatment of psoriasis during study participation, but these should not be used within 12 hours before study visits when efficacy assessments are going to be performed.
2. Ultraviolet A or B phototherapy (without oral psoralen) or psoralen with Ultraviolet A photochemotherapy for the treatment of psoriasis within 4 weeks prior to the first administration of the study drug (Day 1).
3. Any systemic immunomodulating treatments (e.g., MTX, cyclosporine A, corticosteroids, cyclophosphamide, and other systemic nonbiologic therapies \[e.g., apremilast, tofacitinib\]) within 4 weeks prior to the first administration of the study drug (Day 1).
4. Any other investigational device or medical product within 4 weeks prior to the first administration of the study drug (Day 1) or 5 half-lives, whichever is longer.
5. Initiation or dose modification of drugs that may aggravate psoriasis (e.g., beta-blockers, calcium channel blocker or lithium) within 4 weeks prior to the first administration of the study drug (Day 1). Patients who have been on stable dose without exacerbation of psoriasis for at least 4 weeks prior to the first administration of the study drug (Day 1) can be enrolled, however, the same dose should remain throughout the study.
10. Patient who has received live or live-attenuated vaccine within 4 weeks prior to the first administration of the study drug (Day 1), or any planned live or live-attenuated vaccination during the study period.
11. Herbal remedies that could affect the outcome of the study within 2 weeks prior to the first administration of the study drug (Day 1).
12. Patient not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of the study.
13. Patient with inability or unwillingness to undergo repeated venipuncture (e.g., because of poor tolerability or lack of access to veins).
14. Female patient who is currently pregnant or breastfeeding, or plans to become pregnant or breastfeed within 20 weeks of the last dose of study drug. Male patient who is planning to donate sperm or father a child within 20 weeks of the last dose of study drug.
15. Patient who currently abuses alcohol or drugs or has a history of alcohol or drug abuse within 1 year from Screening.
16. Patient is vulnerable (e.g., employees of the study center or any other individuals involved with the conduct of the study, or immediate family members of such individuals, persons kept in prison, or other institutionalized persons by law enforcement).
17. Patient who, in the opinion of their physician or the investigator, should not participate in the study.
2. Patient who has previously received investigational or licensed product of tumor necrosis factor (TNF) α inhibitor for any purposes.
3. 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).
4. 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.
5. Patient who currently has, or has a history of, any of the following infections:
1. 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.
2. Recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug (Day 1).
3. 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.
4. 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.
6. Patient who currently has, or has a history of, any of the following TB conditions:
1. 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.
2. Patient who has had exposure to a person with active TB such as first-degree family members or co-workers.
3. 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.
7. Patient who has a medical condition including one or more of the following:
1. Classified as Class III obesity by WHO classification (body mass index≥40 kg/m2)
2. Diabetes mellitus considered by the investigator to be clinically significant and uncontrolled, even after insulin treatment.
3. Uncontrolled hypertension (as defined by systolic blood pressure \[BP\] ≥160 mmHg or diastolic BP ≥100 mmHg).
4. Active ongoing inflammatory or autoimmune disease other than chronic plaque psoriasis and psoriatic arthritis, that may confound the evaluation of the effect of the study drug.
5. History of a known malignancy within the previous 5 years prior to the first administration of the study drug (Day 1) except completely excised and cured squamous carcinoma of the uterine cervix in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
6. New York Heart Association class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina or clinically significant electrocardiogram \[ECG\] abnormalities), or myocardial infarction within 24 weeks prior to the first administration of the study drug (Day 1).
7. History of organ transplantation, including corneal graft/transplantation.
8. Any underlying condition (e.g., metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) that, in the opinion of the investigator significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.
9. Pre-existing or recent-onset central or peripheral nervous system demyelinating disease, including multiple sclerosis, optic neuritis and Guillain-Barre syndrome.
10. Any other serious acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or study drug administration or that could interfere with the interpretation of study results.
11. History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion.
8. Patient who has the following laboratory abnormalities:
1. Hemoglobin ≤8.0 g/dL (SI \[Système International d'Unités\] units: ≤80 g/L or 4.96 mmol/L).
2. Platelet count \<75× 103 cells/µL (SI units: \<75 × 109 cells/L).
3. Absolute neutrophil count \<1.5 × 103 cells/µL (SI units: \<1.5 × 109 cells/L).
4. Alanine aminotransferase or aspartate aminotransferase \>3.0 × upper limit of normal (ULN).
5. Serum creatinine \>1.5 × ULN or an estimated creatinine clearance level ≤50 mL/min (by Cockcroft-Gault formula) (SI units: 0.84 mL/s).
9. Patient who has received or plans to receive any of following prohibited medications or treatments:
1. Topical treatment for psoriasis or any other skin condition (e.g., corticosteroids, vitamin D analogues, pimecrolimus, retinoids, salicylvaseline, salicylic acid, lactic acid, tacrolimus, tar, urea, α-hydroxy or fruit acids) within 2 weeks prior to the first administration of the study drug (Day 1). However, low-potency topical corticosteroids (Class 6 or 7) applied to the face and intertriginous areas are permitted during study participation to reduce patient's burden with a restriction of use within 12 hours prior to study visits requiring PASI or sPGA measures. Bland moisturizers/emollients not containing pharmacological active ingredients are permitted for treatment of psoriasis during study participation, but these should not be used within 12 hours before study visits when efficacy assessments are going to be performed.
2. Ultraviolet A or B phototherapy (without oral psoralen) or psoralen with Ultraviolet A photochemotherapy for the treatment of psoriasis within 4 weeks prior to the first administration of the study drug (Day 1).
3. Any systemic immunomodulating treatments (e.g., MTX, cyclosporine A, corticosteroids, cyclophosphamide, and other systemic nonbiologic therapies \[e.g., apremilast, tofacitinib\]) within 4 weeks prior to the first administration of the study drug (Day 1).
4. Any other investigational device or medical product within 4 weeks prior to the first administration of the study drug (Day 1) or 5 half-lives, whichever is longer.
5. Initiation or dose modification of drugs that may aggravate psoriasis (e.g., beta-blockers, calcium channel blocker or lithium) within 4 weeks prior to the first administration of the study drug (Day 1). Patients who have been on stable dose without exacerbation of psoriasis for at least 4 weeks prior to the first administration of the study drug (Day 1) can be enrolled, however, the same dose should remain throughout the study.
10. Patient who has received live or live-attenuated vaccine within 4 weeks prior to the first administration of the study drug (Day 1), or any planned live or live-attenuated vaccination during the study period.
11. Herbal remedies that could affect the outcome of the study within 2 weeks prior to the first administration of the study drug (Day 1).
12. Patient not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of the study.
13. Patient with inability or unwillingness to undergo repeated venipuncture (e.g., because of poor tolerability or lack of access to veins).
14. Female patient who is currently pregnant or breastfeeding, or plans to become pregnant or breastfeed within 20 weeks of the last dose of study drug. Male patient who is planning to donate sperm or father a child within 20 weeks of the last dose of study drug.
15. Patient who currently abuses alcohol or drugs or has a history of alcohol or drug abuse within 1 year from Screening.
16. Patient is vulnerable (e.g., employees of the study center or any other individuals involved with the conduct of the study, or immediate family members of such individuals, persons kept in prison, or other institutionalized persons by law enforcement).
17. Patient who, in the opinion of their physician or the investigator, should not participate in the study.
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Celltrion
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CT-P17 3.3 investigational site
Tallinn, , Estonia
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Estonia
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-002336-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CT-P17 3.3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT00237887
COMPLETED
PHASE3
Pharmacokinetic, Efficacy, Safety, and Immunogenicity of AVT02 With Moderate to Severe Chronic Plaque Psoriasis
NCT04453137
COMPLETED
PHASE3
Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
NCT00735787
COMPLETED
PHASE4
Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy
NCT04263610
COMPLETED
PHASE4
Study of Efficacy and Safety of HLX03 in Subjects With Moderate to Severe Plaque Psoriasis
NCT03316781
COMPLETED
PHASE3
Study of Adalimumab (HUMIRA®) in Patients With Moderate to Severe Psoriasis (PS) in Spain (PROMISE)
NCT01076192
COMPLETED
Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy
NCT00566722
COMPLETED
PHASE3
Efficacy, Safety and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis
NCT02850965
COMPLETED
PHASE3
Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis
NCT01970488
COMPLETED
PHASE3
A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis
NCT04673786
COMPLETED
PHASE3
Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT00646191
COMPLETED
PHASE2
Chronic Plaque Psoriasis (Ps) Registry
NCT00799877
COMPLETED
MSB11022 in Moderate to Severe Chronic Plaque Psoriasis
NCT02660580
COMPLETED
PHASE3
Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT00645814
COMPLETED
PHASE2
Efficacy and Safety of Tildrakizumab 100 Milligrams (mg) in Participants With Moderate-Severe Chronic Plaque Psoriasis and Its Impact on Their Quality of Life (TRIBUTE)
NCT04229836
COMPLETED
PHASE4
A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011)
NCT01729754
COMPLETED
PHASE3
Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis
NCT02581345
COMPLETED
PHASE3
The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis
NCT03927352
UNKNOWN
PHASE3
Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT00195676
COMPLETED
PHASE3
Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study
NCT01877668
COMPLETED
PHASE3
A Study to Evaluate Raptiva in Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had an Inadequate Response to an Anti-TNF Agent
NCT00336973
COMPLETED
PHASE4
Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year
NCT01365455
COMPLETED
PHASE3
A Study to Determine the Optimal Dose of Tildrakizumab (SCH 900222/MK-3222) for the Treatment of Moderate-to-severe Chronic Plaque Psoriasis (P05495) (MK-3222-003)
NCT01225731
COMPLETED
PHASE2