Hulio® interchangeability to Humira®, comparing pharmacokinetics, efficacy, safety and immunogenicity

Phase 1

Conditions: Moderate to Severe chronic plaque psoriasis
MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2021-006015-29-EE

Lead Sponsor: Mylan Pharmaceuticals Inc., a Viatris Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 370

Inclusion Criteria

1. Able to understand and voluntarily provide written informed consent to participate in the study
2. Aged 18 to 75 years, inclusive, at the time of Screening
3. Has moderate to severe chronic plaque psoriasis for at least 6 months prior to screening and that has involved body surface area (BSA) =10%, PASI =12, and static Physicians Global Assessment (sPGA) =3 (moderate) at Screening and at Baseline
4. Has stable disease for at least 2 months (i.e., without significant changes as defined by the principal investigator [PI] or designee)
5. Is a candidate for systemic therapy or phototherapy
6. Has a previous failure, inadequate response, intolerance, or contraindication to at least one conventional antipsoriatic systemic therapy, including methotrexate, cyclosporine, psoralen plus ultraviolet light A (PUVA), and ultraviolet light B (UVB)
7. Willing to follow the contraception requirement, based on the childbearing potential.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 314
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion Criteria

1. Has been diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (e.g., eczema), or other systemic autoimmune disorder/ inflammatory disease at the time of the Screening visit that would interfere with evaluations of the effect of the study treatment of psoriasis
2. Prior and concomitant medications: Has prior use of any of the following medications within specified time periods or will require use during the study:
a) Topical medications within 2 weeks of baseline (Week 1)
b) PUVA phototherapy and/or UVB phototherapy within 4 weeks prior to Baseline visit
c) Nonbiologic psoriasis systemic therapies (eg, cyclosporine, methotrexate, and acitretin) within 4 weeks prior to Baseline visit
d) Any prior or concomitant adalimumab therapy, either approved or investigational
e) Any systemic steroid in the 4 weeks prior to Baseline Visit
3. Has received live or attenuated vaccines during the 4 weeks prior to Screening or has the intention of receiving a live or attenuated vaccine at any time during the study
4. Other medical conditions: Known chronic or relevant acute TB; IGRA TB test or PPD skin test will be performed according to the labelling for Humira. If the result is positive, patients may participate in the trial if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active TB. If latent TB is confirmed, then treatment must have been initiated before treatment in the study and continued according to local country guidelines.
5. Has an underlying condition (including, but not limited to, metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious, or gastrointestinal) which, in the opinion of the PI or designee, significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
6. Has a planned surgical intervention during the duration of the study and which, in the opinion of the PI or designee, will put the subject at further risk or hinder the subject’s ability to maintain compliance with study treatment and the visit schedule
7. Has any active and serious infection or history of infections.
8. Is positive for human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B surface antigen (HbsAg) or is positive for hepatitis B core antibody (HbcAb) at Screening
9. Has laboratory abnormalities, including but not limited to clinically significant hematological abnormalities, that, in the opinion of the PI or designee, could cause this study to be detrimental to the subject.
10. Has severe progressive or uncontrolled, clinically significant disease that in the judgment of the PI or designee renders the subject unsuitable for the study
11. Has a history of malignancy within 5 years except for adequately treated cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma
12. Has an active neurological disease, such as multiple sclerosis, Guillain-Barré syndrome, optic neuritis, and transverse myelitis, or a history of neurologic symptoms suggestive of central nervous system demyelinating disease
13. Has moderate to severe heart failure
14. Has a history of hypersensitivity to the active substance or to any of the excipients of Humira or Hulio
15. Is pregnant or nursing (lactating) woman
16. Has evidence (as assessed by the PI or designee

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate interchangeability of Hulio and Humira by examining adalimumab steady-state PK in a switching arm (following 3 switches between Humira and Hulio) as compared to a non-switching arm (receiving only Humira).;Secondary Objective: To evaluate other serum adalimumab PK parameters, efficacy, immunogenicity, safety, and tolerability, in the switching arm and the non-switching arm.;Primary end point(s): The primary endpoints include the assessment of below mentioned pharmacokinetic parameters:<br>- AUCt, 26-28 (Area under the adalimumab concentration-time curve [AUC] over the<br>dosing interval of Week 26-28)<br>- Cmax, 26-28 (Maximum observed adalimumab concentration during the dosing<br>interval Week 26-28).<br>;Timepoint(s) of evaluation of this end point: AUCt- over the dosing interval of Week 26-28<br>Cmax - during the dosing interval Week 26-28

Secondary Outcome Measures

Name	Time	Method

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