Safety and therapeutic effect of administration of Jusvinza in the chronic stage of Chikungunya infection

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.

Acronym of Public Title:

FENIK-2

Scientific title:

Safety and therapeutic effect of subcutaneous administration of Jusvinza in patients in the chronic stage after Chikungunya virus infection. FENIK-2 Study.

Acronym of Scientific Title:

FENIK-2 Study

Secondary indentifying numbers:

IG/JUSVINZASC/CHIKV/2506

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB), Havana City

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana City

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:

Marlibia

Midle name:

de la Caridad

Last name:

Almendariz

Medical Specialty :

First-degree specialist in Comprehensive General Medicine and Rheumatology.

Affiliation:

University Clinical Surgical Hospital “Comandante Faustino Perez Hernandez”

Postal address:

Carretera Central Km. 101., Matanzas

City:

Matanzas

País:

Cuba

Zip Code:

40100

Telephone:

+53-54118359

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:

Not applicable

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

09/12/2025

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:

Post-CHIKV infection arthritis in chronic stage

Intervention(s):

Group A (Experimental): Jusvinza 0.5 mg every 24 hours, subcutaneously for 3 days in the first week, for 2 days in the second week and one dose per week in weeks 3 to 6 (9 doses in total). Group B (Control): Conventional therapy according to the Cuban Protocol for the clinical management of CHIKV infection (Management and research protocol for patients with Chikungunya).

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):

Clinical activity of the disease according to the DAS28 scale (DAS28 scale: Remission (< 2.60); Low activity (2.60 to ≤ 3.20); Moderate activity (>3.20 to ≤ 5.10); and High activity (> 5.10)). Measurement time: At baseline, Day 8, Week 6, Week 12, and Week 24.

Key secondary outcomes:

1. Evaluation of the intensity of pain by the patient. For the evaluation scale, a score (0-10) will be considered, going through the categories without pain (0), mild pain (2), moderate (4), severe (6), very severe (8) and maximum pain (10). Measurement time: At baseline, day 8, week 6, week 12, week 24. 2. Classification of disability in the patient (HAQ-DI. Score No disability 0.000 Mild to moderate 0.000 to 1.000 Moderate to severe 1.001 to 2.000 Severe to very severe > 2.000). Measurement time: At baseline, day 8, week 6, week 12, week 24. 3. Quality of life (SF-36 questionnaire. Assessed on a scale of 0 to 100, where 0 = worst health status and 100 = best health status. A scale that considers eight dimensions: Physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health). Measurement time: At baseline, and Week 6. 4. Study of CD4+, CD25+, and CD127 lymphocyte subpopulations by flow cytometry (Commercially available reagents for labeling human Treg cells will be used. Biological sample type: whole blood. The result is the percentage of T cells expressing the CD4+CD25+CD127- phenotype. It will be considered positive when an increase greater than 1.5 is detected relative to time zero). Measurement time: At baseline and week 6 5. Quantification of proinflammatory cytokines (TNF alpha, IFN gamma, IL-6, IL-17 by ELISA assay using commercially available reagents in plasma or serum). Measurement time: At baseline and week 6

Selection criterias

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

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

80 years

Inclusion criteria:

1. Clinical diagnosis of Chikungunya virus infection. 2. Patients in the chronic stage of the disease, defined by persistent symptoms lasting more than 90 days after the onset of acute symptoms. 3. Presence of persistent arthritis affecting at least one joint and interfering with quality of life or daily functioning. 4. Age between 19 and 80 years. 5. Laboratory parameters within normal limits (considering the type of processing and equipment used in the clinical laboratory) or outside the normal range, but not clinically significant in the investigator's judgment. The following lower limits are established as thresholds for patient inclusion: o Hemoglobin ≥ 8.5 g/L, a value justified by RA activity. o Hematocrit 0.28 in women and 0.31 in men. o White blood cell count ≤ 3000/µL = 3 x 10⁹/L. o Absolute neutrophil count ≥ 1500/µL = 1.5 x 10⁹/L. o Platelet count ≥ 100,000/µL = 100 x 10⁹/L. 6. Express and written consent from the patient to participate in the EC, through their signature on the participation consent form.

Exclusion criteria:

1. Clinical diagnosis of Chikungunya virus infection with a duration of <21 days (acute stage) or between 21 and 3 months (post-acute stage). 2. Clinically relevant, out-of-range clinical laboratory values. 3. Current treatment with Jusvinza. 4. History of allergy or known contraindication to the intervention product being evaluated in the clinical trial. 5. Previous or current treatment with another biological therapy (<3 months). 6. Current treatment with another investigational product. 7. Concomitant active infections that may explain the joint symptoms (e.g., active tuberculosis). 8. Confirmed diagnosis of malignancy. 9. Confirmed diagnosis of congenital or acquired immunodeficiency. 10. Confirmed diagnosis of hematological disease. (Acute or chronic leukemia, lymphoma, plasma cell dyscrasias, coagulation disorders) 11. Complicated chronic diseases. 12. Confirmed diagnosis of alcoholism or drug addiction. 13. Patient with intellectual or sensory psychological dysfunction who cannot understand and/or complete the questionnaires in the study, according to the clinical investigator's criteria. 14. Female patient of childbearing age who does not use effective contraceptive methods (intrauterine devices, barrier methods, or tubal ligation) or male patient who does not use effective methods to prevent procreation (condom or vasectomy). 15. Pregnancy, postpartum period, or breastfeeding.

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:

Open

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

128

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:

Yudisay

Last Name:

Reyes Pelier

Specialty:

First-degree specialist in Oncology

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72085887

Email :

yudisay.reyes@cigb.edu.cu [1]

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:

Francisco

Last Name:

Hernandez-Bernal

Specialty:

First and Second degree specialist in Hygiene and Epidemiology

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72085887

Email :

hernandez.bernal@cigb.edu.cu [2]

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

University Clinical Surgical Hospital “Comandante Faustino Perez Hernandez”

Status of evaluation:

In review

Status of evaluation date of Ethic Committee:

11/11/2025

Postal address of Ethic Committee :

Carretera Central Km. 101, ZC: 40100, Matanzas, Cuba

Telephone:

+53-45 247016

Correo electrónico:

claralaucirica.mtz@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

14/08/2026

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:

RPCEC00000464

Date of Registration in Primary Registry:

17/11/2025

Record Verification Date:

2025/11/17

Next update date:

2026/11/17

Link to the spanish version:

Click here [3]