Study to Evaluate the Efficacy and Safety of high induction doses of adalimumab in moderate to severe psoriasis patients.
- Conditions
- Moderate to severe chronic plaque psoriasisMedDRA version: 19.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2016-001593-15-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 368
1. Male and female patients aged = 18 years.
2. Patients with moderate-to-severe chronic plaque psoriasis.
3. Subject has a diagnosis of chronic plaque psoriasis as determined by
subject medical history and confirmation of diagnosis through physical examination by the Investigator, with disease duration of at least 6 months since diagnosis. Subjects with concomitant hand, feet, scalp or nail psoriasis will be permitted into this study.
4. PASI score = 12 and/or BSA=10.
5. Investigator Global Assessment (IGA) mod 2011 score = 3 (based on a scale of 0 - 4).
6. Patients who are candidates for systemic therapy.
7. Disease inadequately controlled by phototherapy or previous systemic therapy or by 1 approved biological therapy.
8. Methotrexate therapy (=25 mg/week) allowed if the dose was stable for at least 4 weeks before baseline visit.
9. Subject has a negative TB Screening Assessment. If the subject has evidence of a latent TB infection; the subject must initiate and complete a minimum of 2 weeks of an ongoing TB prophylaxis or have documented completion of a full course of TB prophylaxis, prior to Baseline.
10. If female, must meet one of the following criteria:
If female subject, is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for at least 28 days after last dose of study drug.
Examples of approved methods of birth control include the following:
• Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD);
• Hormonal contraceptives for 90 days prior to study drug administration;
• A vasectomized partner.
11. Subject is judged to be in good health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray (CXR), and a 12-lead electrocardiogram (ECG) performed during Screening (For subjects with a normal CXR or ECG taken within 90 days of Screening, a repeat CXR or ECG at Screening will not be required, provided all protocol required documentation is available at the site).
12. Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
13. Subjects must be able and willing to self-administer SC injections or have a qualified person available to administer SC 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 368
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 368
1. Psoriasis other than chronic plaque-type.
2. Diagnosis of other active skin diseases or skin infections.
3. Known hypersensitivity to adalimumab or its excipients.
4. History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
5. History of invasive infection (e.g. listeriosis and histoplasmosis), human immunodeficiency virus (HIV).
6. Subjects with any active viral infection that based on the investigator’s clinical assessment makes the subject an unsuitable candidate for the study.
7. Hepatitis B: HBs Ag positive (+) or detected sensitivity on the HBV-DNA PCR qualitative test for HBc Ab/HBs Ab positive subjects. (See section 5.3.1.1.15)
8. Chronic recurring infections or active TB.
9. Evidence of dysplasia or malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
10. History of moderate to severe congestive heart failure (NYHA class III or IV), recent cerebrovascular accident and any other condition which would put the subject at risk by participation in the study.
11. Clinically significant abnormal screening laboratory results as evaluated by the Investigator.
12. Prior exposure to biologics that have a potential or known association with PML (progressive multifocal leukoencephalopathy) i.e., natalizumab (Tysabri®), or rituximab (Rituxan®).
13. Ongoing use of topical therapy at baseline visit.
14. Ongoing use of systemic therapy (Cyclosporine, retinoids and fumaric acid esters) or UVA or UVB phototherapy including PUVA at baseline visit.
15. Ongoing use of biological therapy at baseline visit.
16. Current treatment with any investigational drug of chemical or biologic nature or within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to the Baseline visit.
17. Received topical psoriasis therapy (e.g., keratolytics, coal tar, anthralin, etc.) within 2 weeks of the Baseline visit.
18. Subject has been treated with systemic corticosteroids (oral or parenteral) 4 weeks (28 days) or topical corticosteroids 2 weeks (14 days) prior to Baseline. Inhaled corticosteroids for stable medical conditions are allowed.
19. Received UVA or UVB phototherapy including PUVA or used a tanning booth 4 weeks prior to the Baseline visit.
20. Cyclosporine, retinoids and fumaric acid esters, must be washed out for at least 4 weeks before the baseline visit.
21. Ongoing Methotrexate treatment if >25 mg/week or unstable 4 weeks before baseline visit.
22. Subject may have prior exposure to JAK inhibitors as long as they have been off therapy for at least 5 half-lives
23. Subject may have prior exposure to PDE4 inhibitors as long as they have been off therapy for at least 5 half-lives (45h).
24. Prior exposure to adalimumab.
25. Failure of more than 1 prior approved biological therapies.
26. Prior exposure to any TNF inhibitors within 5 half-lives of the screening visit:
- Etanercept received < 3 weeks (21 days) before Baseline
- Infliximab received < 8 weeks (56 days) before Baseline
27. Prior exposure to any IL-17 inhibiting biological therapy and/or IL12/23 or IL-23 inhibitors within 5 half-lives of the screening visit:
- IL-17 received < 9 weeks (67 days)
- IL 12/23 received < 15 weeks (85 days)
28. Receipt of any live vaccine within 1 month prior to the Screening visit, or will require vaccination during
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method