| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Moderate to severe plaque psioriasis |
|
| E.1.1.1 | Medical condition in easily understood language |
| Skin disease appearing as raised, inflamed and scaly patches of skin that may also be itchy and painful in moderate to severe form. |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10071117 |
| E.1.2 | Term | Plaque psoriasis |
| E.1.2 | System Organ Class | 100000004858 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| The primary objective of this study is to assess the pharmacokinetic (PK) similarity in subjects with moderate to severe plaque psoriasis who switch between Humira® and SB5 to those receiving Humira® continuously. |
|
| E.2.2 | Secondary objectives of the trial |
The secondary objectives are:
• To evaluate PK in subjects who switch between Humira® and SB5 to those receiving Humira® continuously other than primary endpoints
• To evaluate efficacy, safety, tolerability, and immunogenicity in subjects who switch between Humira® and SB5 to those receiving Humira® continuously
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
For lead-in period:
1. Age of 18 to 80 years at Screening (defined as the time of signing the informed consent form [ICF]).
2. Have a) no history of adalimumab (including biosimilars) or cell-depleting biologics (such as rituximab, etc) use, and b) no history of any other biologic (defined as any therapeutic monoclonal antibody or fusion receptor protein) use within 6 months prior to Week 0.
3. Have plaque psoriasis diagnosed at least 6 months prior to Screening, with or without psoriatic arthritis.
4. Have plaque psoriasis at Screening and Week 0 with the involvement and severity defined as the following:
a. Total affected body surface area (BSA) ≥ 10%.
b. Psoriasis Area and Severity Index (PASI) score of ≥ 12.
c. Physician’s Global Assessment (PGA) score of ≥ 3 (moderate).
5. Considered to be a candidate for phototherapy or systemic therapy for psoriasis at Screening.
6. Adequate haematological function at Screening
7. Adequate renal and hepatic function at Screening
8. Non-childbearing potential female (e.g., permanently sterilised, postmenopausal, OR
Childbearing potential female subjects or male subjects with their (respectively male or childbearing female) partners who agree to use at least two forms of appropriate contraception method from Screening until 5 months after the last dose of IP.
9. Have provided informed consent and must be able to, in the opinion of the Investigator, understand the implications of taking part in the study and be willing to follow the study requirements.
For Switching Period:
1. Have achieved at least an PASI50 response on Week 13 visit assessment.
2. Are willing to participate in the rest of study and able to follow the study procedure with the opinion of the Investigator.
|
|
| E.4 | Principal exclusion criteria |
For lead-in period:
1. Have nonplaque forms of psoriasis, including erythrodermic, pustular, guttate, or drug-induced psoriasis at Screening.
2. Have other skin disease than psoriasis that requires topical, phototherapy or systemic therapy, or may confound the efficacy evaluation per Investigator discretion at Screening.
3. Known allergic reactions or hypersensitivity to adalimumab or to any ingredients of Humira® or SB5, or any history of Stevens-Johnson syndrome or erythema multiforme at Screening.
4. Have received any treatment or therapy of the following, within 4 weeks prior to Week 0:
a. Phototherapy
b. Conventional systemic therapy
Vitamin D (cholecalciferol or ergocalciferol) will be permitted only for non-psoriasis purposes, up to 2000 IU/day. Other vitamin D analogues such as calcitriol, etc. are prohibited.
c. Other immunosuppressants or immunomodulators
5. Have received topical therapy for psoriasis within 2 weeks prior to Week 0.
US class 6/7 topical corticosteroids limited on face and groins will be permitted.
Bland emollients that do not contain excluded ingredients will be permitted.
6. Have received an IP from another study within 5 half-lives of that product prior to Week 0 or use of an investigational device at Week 0.
7. 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.
8. Have received a live or live attenuated vaccine within 8 weeks prior to Week 0. Non-live or live attenuated Coronavirus Disease 2019 (COVID-19) vaccines are permitted at any time.
9. Have active or latent tuberculosis (TB) at Screening
10. Have an ongoing infection or a positive test of hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV) infection, or any history of primary immunodeficiency at Screening.
11. History of sepsis, chronic or recurrent infection, conditions that require regular antibiotic prophylaxis, opportunistic, granulomatous, or invasive fungal infection at Screening.
12. History of other bacterial, fungal, viral, parasitic, or helminthic infection requiring oral antimicrobial within 2 weeks prior to Week 0 or a serious infection within 8 weeks prior to Week 0. Other mild infections should be resolved before Week 0. For COVID-19, please see below.
13. History of lymphoproliferative disease or leukaemia at Screening.
14. History of malignancy (except for squamous or basal cell carcinoma of the skin that has been treated and not recurred within 3 months prior to Screening, or surgically treated cervical carcinoma in situ) within the last 5 years prior to Screening.
15. History of demyelinating disease (including multiple sclerosis, optic neuritis or Guillain-Barré syndrome) at Screening.
16. History of systemic or cutaneous lupus erythematosus at Screening.
17. History of myocardial infarction, unstable angina, or stroke within 12 months prior to Week 0, or any history of New York Heart Association (NYHA) III/IV congestive heart failure (CHF) at Week 0.
18. History of interstitial lung disease or pulmonary fibrosis at Screening.
19. Have uncontrolled hypertension at Screening.
20. Have uncontrolled diabetes mellitus (defined as having history of diabetic peripheral neuropathy or diabetic foot, or otherwise considered uncontrolled in the opinion of the Investigator) at Screening.
21. History of organ transplantation at Screening.
22. Evidence of alcohol or drug abuse within the last 12 months prior to Screening.
23. Have a psychiatric disease that is unstable or uncontrolled, in the opinion of the investigator, at Screening.
24. History of a major surgery in the opinion of the Investigator within 12 weeks prior to Week 0 or have a plan to do so during the study period.
25. Have other major organ dysfunction or failure such as liver cirrhosis, dialysis-dependent renal failure, any cardiopulmonary disease with functional disability of NYHA III/IV equivalent, aplastic anaemia or any other transfusion-dependent/stimulating factor dependent haematological disorders, or dementia at Screening.
26. History of COVID-19 as:
a. History of COVID-19 within 8 weeks prior to Week 0.
b. Any history of hospitalisation (not simple quarantine) due to COVID-19 at Week 0.
c. Any history of COVID-19 major complications or long-term sequalae at Week 0.
Note: Subjects must be evaluated and determined to be COVID-19 negative per local regulations before Screening.
27. Have any other disease or disorder, that will put the subject at risk if they are enrolled, in the opinion of the Investigator, at Screening.
28. Have poor venous access or unwillingness to undergo multiple venepuncture and blood sampling at Screening.
For switching period:
1. Subject is considered to be of increased risk when entered in the switching period, in the opinion of the Investigator. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
• Area under the concentration-time curve over the dosing interval (AUCtau)
• Maximum serum concentration (Cmax) during the dosing interval
|
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
• Area under the concentration-time curve over the dosing interval (AUCtau) of Week 23-25 (AUCtau, 23-25 wk)
• Maximum serum concentration (Cmax) during the dosing interval of Week 23-25 (Cmax, 23-25 wk) |
|
| E.5.2 | Secondary end point(s) |
The secondary PK endpoints are:
• Time to Cmax (Tmax) during the dosing interval
• Trough serum concentration of adalimumab (Ctrough)
The efficacy endpoints are:
• PASI50, PASI75, and PASI90 response rate and percent change from baseline in PASI
• PGA
• Change from baseline in Dermatology Life Quality Index (DLQI)
The safety endpoints are:
• Incidence of adverse events (AEs)
• Incidence of serious AEs (SAEs)
• Incidence of adverse events of special interest (AESIs)
• Change in vital sign and clinical laboratory parameters
The immunogenicity endpoints are:
• Incidence of anti-drug antibodies (ADAs)
• Incidence of neutralising antibodies (NAbs) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
The secondary PK endpoints:
• Time to Cmax (Tmax) during the dosing interval of Week 23-25 (Tmax, 23-25 wk)
• Trough serum concentration of adalimumab (Ctrough) at Week 0, 1, 5, 9, 13, 15, 17, 19, 21, and 23
The efficacy endpoints:
• PASI50, PASI75, and PASI90 response rate and percent change from baseline in PASI at Week 5, 9, 13, 17, 21, and 25
• PGA at Week 5, 9, 13, 17, 21, and 25
• Change from baseline in Dermatology Life Quality Index (DLQI) at Week 5, 13, 21, and 25
The safety endpoints:
• during whole duration of trial
The immunogenicity endpoints:
• Incidence of anti-drug antibodies (ADAs) at Week 0, 5, 9, 13, 17, 19, 23, and 25
• Incidence of neutralising antibodies (NAbs) at Week 0, 5, 9, 13, 17, 19, 23, and 25
|
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 33 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| The end of the study (EOS) is defined as completion of the last subject's Week 29 visit or the last activity for early termination (ET) if the last subject is prematurely discontinues the IP. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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