.a.

Phase 1

Active, not recruiting

• Conditions: Moderate to severe psoriasis.; MedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-002012-13-IT
• Lead Sponsor: IRCCS ISTITUTO CLINICO HUMANITAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-07
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Subject has provided informed consent
2.Subject is ¿ 18 and ¿ 75 years of age at time of screening
3.Subject has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the Investigator)
4.Subject has involved body surface area (BSA) ¿ 10%, PASI ¿ 10, at baseline
5. For women, except those at least 2 years post-menopausal (defined as no menses for 12 months without an alternative medical cause) or surgically sterile: a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline.
6. Women with child bearing potential must agree to use Highly effective method of contraception during the treatment and until the end of relevant systemic exposure including: - combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: - oral - intravaginal - transdermal; progestogen-only hormonal contraception associated with inhibition of ovulation: - oral- injectable, - implantable; intrauterine device (IUD); intrauterine hormone-releasing system ( IUS).
7. Males with women of childbear potential partners must agree to use contraception during the treatment and until the end of relevant systemic exposure.
8.Subject has no known history of active tuberculosis
• Subject has a negative test for tuberculosis during screening defined as either:
• negative purified protein derivative (PPD) (< 5 mm of induration at 48 to 72 hours after test is placed)
OR
• negative Quantiferon test
• Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon test
9.Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate Quantiferon test are allowed if they have all of the following:
•no symptoms per tuberculosis worksheet provided by the Sponsor
•documented history of adequate prophylaxis initiation prior to receiving study drug in accordance with local recommendations
•no known exposure to a case of active tuberculosis after most recent prophylaxis
•no evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product
10.Subject is a candidate for systemic therapy or phototherapy
11.Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy (eg, cyclosporine, psoralen plus ultraviolet light [UV] A)
12.Subject should not be previously treated with methotrexate or ustekinumab
13.Subject is able to complete study procedures, including self-assessments and self-injections.
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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Skin disease related
1.Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
Other medical conditions
2.Subject has a planned surgical intervention during the duration of the study.
3.Subject has an active infection or history of infections as follows:
•any active infection for which systemic anti-infectives were used within 28 days prior to first dose of investigational product
•a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first dose of investigational product
•recurrent or chronic infections or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject
4.Subject has known history of human immunodeficiency virus
5.Hepatitis B surface antigen or Hepatitis C antibody or HIV positivity at screening
6.Subject has uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease, renal failure, liver disease, or hypertension
7.Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma
8.Subject has history of malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma
9.Subject has active neurological disease such as multiple sclerosis, Guillain-Barre syndrome, optic neuritis, transverse myelitis or history of neurologic symptoms suggestive of central nervous system demyelinating disease
10.Subject has moderate to severe heart failure (New York Heart Association [NYHA] class III/IV)
11.Subject has a history of hypersensitivity to the active substance or to any of the excipients of adalimumab
12.Subject has any concurrent medical condition that, in the opinion of the Investigator, could cause this study to be detrimental to the subject
Laboratory abnormalities
13.Laboratory abnormalities at screening, including any of the following:
•Hemoglobin < 9 g/dL
•Platelet count < 100,000/mm3
•White blood cell count < 3,000 cells/mm3
•Absolute neutrophil count (ANC) < 1000/mm3
•Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ¿ 1.5 x the upper limit of normal
•Creatinine clearance < 50 mL/min (Cockroft-Gault formula)
•Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results
Washouts and non-permitted drugs
14.Subject has used UV B therapy within 14 days before first dose of investigational product
15.Subject has used topical therapy for psoriasis as follows:
•superpotent (class I) or potent (class II) topical steroids or topical anthralin within 14 days before first dose of investigational product
•any other formulation or potency of topical therapy or UV B phototherapy within 14 days before first dose of investigational product (exception: upper mid-strength to least potent [class III to VII] topical steroids permitted on the palms, soles, face and intertriginous areas)
16.Subject has used the following within 28 days of first dose of investigational product:
•UV A light therapy (with or without psoralen) or excimer laser;
•non-biologic syste

Study & Design

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