Effectiveness and Safety of Jusvinza in Patients with Chikungunya

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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.

Acronym of Public Title:

FENIK-3

Scientific title:

Effectiveness and Safety of Jusvinza in the Treatment of Patients in Post-acute and Chronic Stages after Chikungunya Infection. Phase 3 Clinical Trial Compared with Historical Control.

Acronym of Scientific Title:

FENIK-3

Secondary indentifying numbers:

IG/JUSVINZASC/CHIKV/2603

Issuing authority of the secondary identifying numbers:

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

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba. Ministry of Public Health (MINSAP), Cuba

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:

Dinorah

Midle name:

Marisabel

Last name:

Prada Hernández

Medical Specialty :

Doctor of Medicine; First-degree Specialist in General Integral Medicine and Second-degree Specialist in Rheumatology

Affiliation:

Teaching Clinical-Surgical Hospital "10 de Octubre"

Postal address:

10 de Octubre No. 130 b/. Alejandro Ramírez and Agua Dulce, Cerro

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

+53-78252009 ext. 42

Email address:

dinoprada@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:

Clínica 1, La Lisa. Havana. Leslyhana Verdecia Sánchez MD. First degree Specialist in Internal Medicine

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

16/03/2026

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:

Chikungunya virus infection in post-acute and chronic stages.

Intervention(s):

Group Jusvinza (Experimental): Jusvinza dose 0.5 mg, subcutaneous route (9 doses in total). Administration schedule: One daily dose (every 24 hours) for 6 consecutive days, followed by three weekly doses (every 7 days [± 1 day]), starting from the last daily dose received. All patients will receive conventional therapy established in the MINSAP Protocol for the management and investigations of patients with Chikungunya, which includes the use of analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), and steroids, the latter according to medical criteria, considering the patient’s clinical condition and previously received treatments. Participants will receive the treatment at the clinical site, on an outpatient basis.

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):

Improvement of painful and inflammatory clinical manifestations The assessment will be performed according to the CDAI (Clinical Disease Activity Index), considering remission when < 2.8; low activity between 2.8 and 10.0; moderate activity > 10.0 to 22.0; and high activity when > 22.0. Assessment time points: Baseline (Time 0), Week 2 (7 days [± 1 day] after the 6th dose); Day 45 (± 3 days) andWeek 12 (± 3 days)

Key secondary outcomes:

1. Assessment of pain intensity by the patient. For the evaluation scale, a score (0–10) will be considered, with the following categories: no pain (0), mild pain (2), moderate pain (4), severe pain (6), very severe pain (8), and maximum pain (10). Assessment time points: Baseline (Time 0), Week 2 (7 days [± 1 day] after the 6th dose), Day 45 (± 3 days), Week 12 (± 3 days). 2. Functional capacity. This will be assessed using the HAQ-DI scale, considering no disability when 0.000; mild to moderate between 0.000 and 1.000; moderate to severe from 1.001 to 2.000; and severe to very severe when > 2.000. Assessment time points: Baseline (Time 0), Week 2 (7 days [± 1 day] after the 6th dose), Day 45 (± 3 days), Week 12 (± 3 days). 3. Safety. The occurrence of clinical adverse events will be evaluated. The type, duration, intensity, causality relationship, management, and outcome will be described. Patients will be evaluated during the first hour following administration of the Jusvinza peptide, in person at the clinical site, and will be instructed on the need to contact the FENIK-3 study research team in case of any medical eventuality. Safety monitoring will be carried out throughout the entire duration of the trial (12 weeks). 4. Immunological evaluation. This will include lymphocyte subpopulations (CD4+, CD25+, and CD127–) and quantification of proinflammatory cytokines (TNF alpha, IFN gamma, IL-6, IL-17). Assessment time points: Baseline (Time 0, before administration of the first dose of Jusvinza), Day 45, and Week 12.

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:

None

Inclusion criteria:

1. Fulfillment of diagnostic criteria. 2. Patients in the post-acute stage (21–90 days after onset of acute symptoms) or chronic stage (>90 days) of the disease. 3. Moderate or high disease activity at study entry, defined as a CDAI index > 10.0. 4. Presence of persistent arthritis affecting at least one joint and interfering with quality of life or daily functionality. 5. Age ≥ 19 years. 6. Patient’s willingness to voluntarily participate in the clinical trial.

Exclusion criteria:

1. Patients under treatment with Jusvinza or another investigational product, or who have received other biological therapy within the last three months. 2. Known hypersensitivity to any of the components of the study formulation. 3. Active concomitant infections that may explain joint symptoms (e.g., active tuberculosis). 4. Decompensated chronic, autoimmune, or endocrine-metabolic diseases at the time of inclusion. 5. Pregnancy or breastfeeding (reported). Women of reproductive age who do not use contraceptives or are planning pregnancy. 6. Evident mental incapacity to provide consent and act in accordance with the study.

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:

3

Target sample size:

300

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:

Giselle

Last Name:

Blanco Ferran

Specialty:

First Degree Specialist in Comprehensive General Medicine Doctor of Medicine; First-degree Specialist in General Integral Medicine (GIM)

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 e/ 158 and 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+53-72080428 (ext.108)

Email :

giselle.blanco@cigb.edu.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:

Francisco

Last Name:

Hernandez Bernal

Specialty:

Doctor of Medicine; First- and Second-degree Specialist in Hygiene and Epidemiology

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 e/ 158 and 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+53-72085887 / +53-72087465 (ext.148)

Email :

hernandez.bernal@cigb.edu.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Centralized Ethics Committee of the Clinical Surgical Teaching Hospital "10 de Octubre" with scope to Clinic 1, La Lisa.

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

09/03/2026

Postal address of Ethic Committee :

10 de octubre 130 b/ Alejandro Ramirez y Agua Duce, Cerro. Havana. BO 10300

Telephone:

+53 78252267

Correo electrónico:

hcqdir@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

300

Study completion date:

16/06/2026

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:

RPCEC00000474

Date of Registration in Primary Registry:

31/03/2026

Record Verification Date:

2026/03/31

Next update date:

2027/03/31

Link to the spanish version:

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Effectiveness and Safety of Jusvinza in Patients with Chikungunya

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