T1h in severe psoriasis-expanded access program (PUCE)

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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:

Safety and Therapeutic Effect Study of itolizumab mAb in patients with severe psoriasis.

Secondary indentifying numbers:

IIC RD-EC 135

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM) Cuban Public Health Ministry (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:

Only approved by Ethics Committees

Principal investigator

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

First name:

Leopoldina

Last name:

Falcón Lincheta

Medical Specialty :

MD, PhD, Second degree specialist in Dermatology.

Affiliation:

Hospital "Carlos J Finlay"

Postal address:

31 ave and 114

City:

Havana

Country:

Cuba

Zip Code:

Not entered

Telephone:

+53-5372743000

Email address:

leopoldina.falcon@infomed.sld.cu

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:

Havana, Medical and Surgical Research Center, Aleida Urquiza Rodríguez, MD, Second degree specialist in Dermatology

Santiago de Cuba, Surgical Clinical Hospital "Joaquin Castillo Duany, Maritza Batista Romagosa, MD, Second degree specialist in Dermatology

Havana, Surgical Clinical Hospital "Hermanos Ameijeiras", Teresita Perez Alonso, MD, Second degree specialist in Dermatology

Havana, Hospital "Manuel Fajardo", Alina Maria Viqueira Fuentesfría, MD, Second degree specialist in Dermatology

Camaguey, Hospital "Manuel Ascunse Domenech", Beatriz Mantecón Fernández, MD, Second degree specialist in Dermatology

Research ethics committees:

Surgical Clinical Hospital "Carlos J Finaly", May 19, 2011

Medical and Surgical Research Center, June 7, 2011

Surgical Clinical Hospital "Joaquin Castillo Duany", August 15, 2011

Surgical Clinical Hospital "Hermanos Ameijeiras", July 4, 2011

Hospital "Manuel Fajardo", February 16, 2012

Hospital "Manuel Ascunse Domenech", November 10, 2011

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

15/07/2011

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:

Psoriasis

Intervention(s):

Itolizumab (T1h) 0.4 mg /Kg body weight weekly, (intravenously) by 2 months + Itolizumab (T1h) 0.4 mg /Kg body weight every 4 weeks (intravenously) by 10 months

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):

Adverse events (AE). Measuring time: weeks 5, 9, 12 and every 4 weeks until 12 months. - Presence of AE (Yes/No). -Description of AE. Name of the event -Duration of AE. (Difference between the beginning date and the finish date of the event) -Intensity of AE (Slight, Moderate, Severe) -Severity of AE (Severe/Serious, Not severe/Not serious) - Attitude to study treatment (Unchanged, Dose modification, Temporary discontinuation of study treatment, Permanent discontinuation of study treatment) -Outcome of AE (Recovered, Improved, Persist, Sequelae, Death) -Relationship causality (Definitive, Very likely, Probable, Possible, Not related, Unknown) Clinical Response (PASI: PASI= 90-Response, 50=PASI <90- No response, PASI<50-Worse). Measurement time: weeks 5, 9, 12 and every 4 weeks until 12 months.

Key secondary outcomes:

Not applicable

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:

75 years

Inclusion criteria:

1. Age 18-75 years (Both inclusive), of any gender or skin color 2. Patients with clinical and histopatological diagnozed of active severe psoriasis 3. Patients must have been treated unsuccessfully with, or who are intolerant to or have a contraindication to receiving anti-psoriatic treatments currently available in the country. 4. Baseline PASI =10 5. Patients receiving immunosupressive therapy (including retinoids) for Psoriasis can be included after a washout period of 4 weeks. Oral Glucocorticoids =10 mg/day permitted if stable prior to baseline for Psoriatic arthritis patients. 6. Patients comply with the requirements of the clinical laboratory: •Hemoglobin, men =12.0 g/dL, women =11.0 g/dL, WBC> 3x109 cells / mL, ALC >1.3x109 cel/ml, platelet count > 150x109/mL, ANC= 1,5x109 /L •Creatinine within the normal reference values (UI). •Transaminase (TGP), bilirrubin and alcaline fosfatase (AF) within the normal reference values (UI). 7. Able and willing to give written informed consent.

Exclusion criteria:

1. Uncompensated suffering from chronic diseases (heart diseases, diabetes mellitus, hypertension, chronic renal failure, bronchial asthma) 2. History of or Suffering from any malignancy (including solid tumours, hematologic malignancies and carcinoma in situ) 3. History of Chronic or current infectious disease (at screening patients with chest radiograph and laboratory test) 4. Pregnancy, childbirth and / or breastfeeding. 5. Patients who refuse to use contraception during the study. 6. Patients with intellectual or psychological dysfunction that not allow to understand and compliance with study requirements, according to the Principal 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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

80 patients

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:

Hernández Casaña

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa,

City:

La Habana

Country:

Cuba

Zip Code:

CP 16040, Box 11600

Telephone:

537-2143145

Email :

patriciahc@cim.sld.cu

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:

Hernández Casaña

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa,

City:

La Habana

Country:

Cuba

Zip Code:

CP 16040, Box 11600

Telephone:

537-2143145

Email :

patriciahc@cim.sld.cu

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:

RPCEC00000132

Date of Registration in Primary Registry:

2012-07-20

Record Verification Date:

2015/08/28

Next update date:

2016/08/28

Link to the spanish version:

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Registered Trials

Registration process

T1h in severe psoriasis-expanded access program (PUCE)

About the RPCEC

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