Moderate to severe chronic plaque psoriasis MedDRA version: 19.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: AbbVie Ltd.
Concentration unit: mg millig
Sponsors
Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of adalimumab when administered at doses of 160 mg at week 0 followed by 40 mg at Week 1 and then 40mg every other week from week 3 until week 15 vs placebo 80 mg and adalimumab 80mg at Week 0 and then adalimumab 40mg every other week from Week 1 until week 15 included, in the treatment of patients with moderate to severe plaque-type psoriasis at 12 weeks.;Secondary Objective: • Evaluate the efficacy of adalimumab when administered at doses of 160 mg at week 0 followed by 40 mg at Week 1 and then 40mg every other week from week 3 until week 15 vs placebo 80 mg and adalimumab 80mg at Week 0 and then adalimumab 40mg every other week from Week 1 until week 15 included, in the treatment of patients with moderate to severe plaque-type psoriasis at 4 and 16 weeks. • Evaluate HRQoL at 4, 12 and 16 weeks. • Evaluate safety, and tolerability.;Primary end point(s): Percentage of patients achieving PASI 90 response at week 12.;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The percentage of patients achieving PASI 90 at 4 and 16 weeks. • The percentage of patients achieving PASI 50, PASI 75 and PASI 100 at 4, 12 and 16 weeks. • Percentage of patients achieving PASI =3 at 4, 12, and 16 weeks. • The percentage of patients achieving an IGA of clear or almost clear (0/1) at weeks 4, 12 and 16. • The percentage of patients with Dermatology Quality Index (DLQI) of 0 or 1 at weeks 4, 12 and 16. • Pruritus and Pain percentage of change from baseline at weeks 4, 12 and 16. • DLQI percentage of change from baseline at weeks 4, 12 and 16. • Treatment-emergent adverse events, defined as events with an onset date after the first study drug until 70 days following the last study drug administration.;Timepoint(s) of evaluation of this end point: Week 4, 12 and 16. Safety after the first study drug until 70 days following the last study drug administration. | — |
Countries
Spain
Contacts
Public ContactUICEC Sant Pau
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Outcome results
None listed