Itolizumab for Moderate-to-Severe Psoriasis-phase 3

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Randomized controlled double blind trial to study Safety and Efficaccy of itolizumab (antiCD6) in Moderate-to-Severe Psoriasis.

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

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

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Olaine

Last name:

Gray Lovio

Medical Specialty :

MD, second degree specialist in Dermatology

Affiliation:

Clinical Surgery hospital "Manuel Fajardo"

Postal address:

D e/. 29 and Zapata, Vedado, Plaza de la Revolucion

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

+53-78352538

Email address:

ogray@infomed.sld.cu [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Santiago de Cuba, General Hospital "Dr. Joaquin Castillo Duany", Maritza Batista, MD, first degree specialist in Dermatology

Research ethics committees:

Clinical Surgery Hospital "Manuel Fajardo", may 26, 2015

General Hospital "Dr. Joaquin Castillo Duany", in evaluation

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

15/10/2015

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Moderate-to-Severe Psoriasis

Health condition(s) code:

Psoriasis

Skin Diseases, Papulosquamous

Skin Diseases

Health condition keyword:

Psoriasis

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).

Intervention code:

Antibodies, Monoclonal, Humanized

Antigens, CD

Therapeutic use

Intervention keyword:

Itolizumab Antibodies Monoclonal Immunotherapy CD6

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

70 years

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Crossover

Phase:

Target sample size:

144

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Patricia

Last Name:

Hernandez Casaña

Specialty:

PhD, Biochemistry. Clinical Research Promoter

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216th & 15th Ave., Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+537-2717933

Email :

patriciahc@cim.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Patricia

Last Name:

Hernandez Casaña

Specialty:

PhD, Biochemistry. Clinical Research Promoter

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216th & 15th Ave., Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+5372717933

Email :

patriciahc@cim.sld.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000201

Date of Registration in Primary Registry:

08/10/2015

Record Verification Date:

2015/10/08

Next update date:

2016/10/08

Link to the spanish version:

Click here [3]