Multicenter, Double-blind, Randomized, Parallel-group, Study Evaluating Pharmacokinetic, Efficacy, Safety, and Immunogenicity Between Patients with Moderate to Severe Chronic Plaque Psoriasis Receiving Humira® and Patients Undergoing Repeated Switches Between Humira® and AVT02 Followed by a Safety Extension Phase of AVT02

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Chronic Plaque Psoriasis; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-002911-25-IS
• Lead Sponsor: Alvotech Swiss AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-06
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 448

Inclusion Criteria

1. Patient has signed the informed consent form and documentation as required by relevant competent authorities and is able to understand and adhere to the visit schedule and study requirements.
2. Patient is male or female aged 18 to 75 years, inclusive, at the time of Screening.
3. Patients with moderate-to-severe chronic plaque psoriasis who has involved body surface area (BSA) = 10% (Palm Method), = 12 on the PASI, and static Physicians Global Assessments (sPGA) = 3 (moderate) at Screening and at Baseline (Week 1/Day 1).
4. Patient has had stable disease for at least 2 months (ie, without significant changes as defined by the Investigator or designee).
5. Patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
6. Patient is naive to adalimumab therapy, approved or investigational.
7. Patient has a negative QuantiFERON test for tuberculosis (TB) during Screening.
Note: Patients with an indeterminate QuantiFERON test are allowed if they have all of the following:
a. No evidence of active TB on chest radiograph within 3 months prior to the first dose of study drug.
b. Documented history of treatment of TB or adequate prophylaxis initiation with an isoniazid-based regimen > 1 month prior to receiving study drug in accordance with local recommendations.
c. No known exposure to active TB after most recent prophylaxis.
d. Asymptomatic at Screening and Baseline.
Investigators should check with the medical monitor before enrolling such subjects.
8. Women of childbearing potential (except those who are postmenopausal for more than 2 years or if surgically sterile) must have a negative serum pregnancy test during Screening and negative urine pregnancy test at Baseline (Week 1/Day 1).
9. Sexually active women of childbearing potential must agree to use highly effective contraception (sterilization, hormonal contraception pills or injection or implants, sterilization and abstinence) for the duration of the study and until 6 months after the last dose of the study drug.
Male patients must agree to use contraception for the duration of the study and agree not to donate sperm during and for 6 months after the last dose of study drug.

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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

Exclusion Criteria:
1. Patient diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (eg, 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. Patient 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/Day 1).
b. PUVA phototherapy and/or UVB phototherapy within 4 weeks prior to the Baseline (Week 1/Day 1).
c. Nonbiologic psoriasis systemic therapies (eg, cyclosporine, methotrexate, and acitretin) within 4 weeks prior to the Baseline (Week 1/Day 1).
d. Any prior or concomitant adalimumab therapy, either approved or investigational.
e. Any systemic steroid in the 4 weeks prior to Screening.
f. Investigational agent(s) within 90 days or 5 half-lives (whichever is longer) before Baseline (Week 1/Day 1) (Refer to the table in protocol section 3.3.2 for approved/marketed products).
3. Patient has received live or attenuated vaccines during the 4 weeks prior to Screening or intends to receive a live or attenuated vaccine at any time during the study.
4. Patient 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 Investigator or designee, significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
5. Patient has a planned surgical intervention during the duration of the study and which, in the opinion of the Investigator or designee, will put the subject at further risk or hinder the patient’s ability to maintain compliance with study treatment and the visit schedule.
6. Has any active and serious infection or history of infections as follows:
a. Any active infection:
i. For which non-systemic anti-infective were used within 4 weeks prior to randomization. Note: patients receiving topical antibiotics for facial acne do not need to be excluded.
ii. Which required hospitalization or systemic anti-infective within 8 weeks prior to randomization.
b. Recurrent or chronic infections or other active infection that, in the opinion of the Investigator or designee, might cause this study to be detrimental to the subject.
c. Invasive fungal infection or mycobacterial infection.
d. Opportunistic infections, such as listeriosis, legionellosis, or pneumocystis.
7. Patient is positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or hepatitis B surface antigen (HBsAg) and/or is positive for hepatitis B core antibody.
8. Patient has severe progressive or uncontrolled, clinically significant disease that in the judgment of the Investigator or designee renders the subject unsuitable for the study.
9. Patient 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.
10. Patient 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.
11. Patient has moderate to severe heart failu

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified