Itolizumab for Moderate-to-Severe Psoriasis-phase 3

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000201
• Date of registration: 08/10/2015
• Prospective Registration: Yes
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: Itolizumab for Moderate-to-Severe Psoriasis-phase 3
• Scientific title: Randomized controlled double blind trial to study Safety and Efficaccy of itolizumab (antiCD6) in Moderate-to-Severe Psoriasis.
• Date of first enrolment: 15/10/2015
• Target sample size: 144
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000201-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Crossover. Purpose: Treatment
• Phase: 3

Countries of recruitment

Cuba

Contacts

• Name: Patricia Hernandez Casaña
• Affiliation: Center of Molecular Immunology (CIM)

• Name: Patricia Hernandez Casaña
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

Inclusion criteria: 1. Able and willing to give written informed consent.
2. Diagnosis of plaque psoriasis or vulgar.
3. Time course of the disease in at least 1 year.
4. Be tributary of systemic therapy.
5. Willingness to complete a washout period prior to receiving the first dose of treatment (for patients in treatment only): Interrupting or systemic therapy at least four weeks; Interrupting or topical steroid treatment at least 2 weeks
6. moderate to severe psoriasis activity, defined by: Area and Severity Index (PASI) = 10; affected body surface area (BSA) = 10%
7. Normal laboratory values, considering laboratory range of each institution: CBC: Hemoglobin-man = 12.0 g / dl, -women = 11.0 g / dl, leukocytes = 5x109 L, platelets = 150x109 / L, neutrophils = 1.8x109 / L, lymphocytes> 1.2x109 cells / mL; Renal function: Creatinine normal value; Liver function: ALT, AST, GGT, up to 2.5 times the ULN.
8. Age between 18 and 70 years (both included).
Exclusion criteria: 1. Diagnosis of other types of psoriasis, psoriatic arthritis except.
2. Critical State of psoriasis (erythroderma).
3. Suffering from decompensated chronic diseases (heart disease, diabetes mellitus, hypertension, chronic kidney disease, bronchial asthma, etc) to the doctor involves an unreasonable risk to the patient's life.
4. Malignancy.
5. immunocompromised patient.
6. Have received systemic retinoids or immunosuppressive therapy including steroids, within less than 30 days prior to enrollment, except patients with psoriatic arthritis who are receiving stable treatment for at least 30 days prior to inclusion of oral steroids =10 mg /day.
7. significant acute or chronic systemic infection that to the doctor involves an unreasonable risk to the patient.
8. Being treated with a monoclonal antibody, including itolizumab.
9. allergy to any component of the formulation.
10. Pregnancy, postpartum and / or breastfeeding.
11. Be reproductive age and refuse to use contraception (pills, IUDs, barrier methods, etc) during treatment and at least 8 weeks after the last dose of itolizumab.
12. Suffering intellectual or sensory psychological dysfunction that may impede understanding and compliance with the requirements of the study at the discretion of the clinical investigator.










Age minimum: 18 years
Age maximum: 70 years
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Skin Diseases, Papulosquamous

Moderate-to-Severe Psoriasis
Psoriasis

Psoriasis

Skin Diseases

Intervention(s)

Study group (Itolizumab): Itolizumab 1.6 mg/Kg body weight biweekly administered intravenously by 12 weeks (Week 0-8), and every 4 weeks by 24 weeks (Week 12-36).
Control group (Placebo): Placebo 1.6 mg/Kg body weight biweekly administered intravenously by 12 weeks (Week 0-8), then 1.6 mg/Kg body weight biweekly administered intravenously by 12 weeks (Week 12-20), and every 4 weeks by 12 weeks (week 24-36).

Therapeutic use

Antibodies, Monoclonal, Humanized

Antigens, CD

Itolizumab
Antibodies Monoclonal
Immunotherapy
CD6

Primary Outcome(s)

Proportion of subjects achieving PASI75 (patients with improvement in PASI score = 75% from baseline, Day 0). Measuring time: at Week 12

Secondary Outcome(s)

Efficacy outcomes:
-PASI. Assessment of severity of lesions. Determination by physical examination and scaling that combines the assessment of the severity of the lesions (erythema, induration and scaling) and a single score affected area encompassing a range of 0 (no disease) to 72 (maximum severity). Measuring time: weeks 0, 12, 24, 36, 40, 44, 48, 52, 56 and 60.
- Percent improvement in PASI from baseline. (PASI 50, 75, 90, 100). Determining the percent reduction of PASI by the formula:% reduction in PASI (PASI initial - current PASI) / initial PASI * 100. Measuring Time: Weeks 12, 24, 36, 40, 44, 48, 52, 56 and 60.
- Proportion of patients with PASI 50, 75, 90, 100, PASI = 50 but <75 and PASI <50. Patients who achieve a percentage reduction in PASI equal to or greater than 50 percent are classified as PASI 50, and respectively and for the rest of the categories. Measuring Time: Weeks 12, 24, 36, 48 and 60.
- Time to relapse. Time to loss of PASI 50 and PASI 75 response for patients who achieved PASI 50 or greater. Measuring time: Week 36
- Proportion of patients with relapsed. Measuring Time: Weeks 40, 44, 48, 52, 56 and 60.
- Investigator Global Assessment (IGA mod 2011). Static scale modified (2011) of 5 points from the overall assessment of the specialist. Measuring time: weeks 0, 12, 24, 36, 40, 44, 48, 52, 56 and 60.
- Proportion of patients with IGA =1. Measuring Time: Weeks 12, 24, 36, 48 and 60.
- Scale quality of life (DLQI, Dermatology Life Quality Index). Questionnaire with 10 subjects reporting the patient to measure the effect of psoriasis on 6 different aspects of quality of life. Each question has 4 possible answers: no, a little, a lot, and much that is qualified from 0 to 3, respectively. The sum of the response covers range from 0 (none) to 30 (a lot) points. Values 0 and 1 indicate no negative impact on quality of life and more than 10 represents a big impact. Measuring time: weeks 0, 12, 24, 36, 48 and 60.
Safety outcomes:
Incidence of Adverse Events (AE) (type (name of AE), Intensity (Mild, Moderate, Severe), Gravity (Serious, Not serious), causality relationship (Very Likely, Likely, Possible, Not related, Unknown). Measuring time: Weeks 0, 2, 4, 6, 8, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60.
Immunological outcomes:
Percent subpopulations in peripheral blood lymphoid cells, total count of peripheral blood lymphoid cells, frequency T cell precursors, frequency of IFN-gamma secreting T cells, serum cytokines concentration, expression pattern Percent cytosine, Percent of lymphocyte activation. Measuring time: weeks 0, 12, 24, 36, 60.

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

Center of Molecular Immunology (CIM) Ministry of Public Health (MINSAP)

Secondary Sponsor(s)

Not applicable