Safety and therapeutic effect of administration of Jusvinza in the post-acute 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

Scientific title:

Safety and therapeutic effect of subcutaneous administration of Jusvinza in patients in the post-acute stage after Chikungunya virus infection. Phase II Clinical Trial

Acronym of Scientific Title:

FENIK

Secondary indentifying numbers:

IG/JUSVINZASC/CHIKV/2505

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)

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 Hernandez

Medical Specialty :

First degree Specialist in Comprehensive General Medicine; Second degree Specialist in Rheumatology

Affiliation:

"10 de Octubre" Clinical Surgical Teaching Hospital

Postal address:

10 de Octubre No.130 e/ Alejandro Ramirez y Agua Dulce, Cerro

City:

Havana

Country:

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:

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:

Atritis in post-acute Chikungunya virus infection

Intervention(s):

Group A (Experimental): Jusvinza 0,5 mg c/ 24 hours, during 4 days in the first week, , and Jusvinza 0,5 mg one dose per week, in weeks 2 and 3 (Total: 6 doses), subcutaneous route. Grupo B (Experimental): Jusvinza 0,5 mg c/ 24 hours, during 6 days in the first week, , and Jusvinza 0,5 mg one dose per week, in weeks 2, 3 and 4 (Total: 9 doses), subcutaneous route. Grupo C (Control): Conventional therapy according Cuban Protocol for 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 4, week 4, 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, and 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 4, week 3, week 12, and week 24.

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 who go through the post-acute phase of the disease defined by the presence of persistent symptoms between the range of 21 and 90 days after the onset of acute symptoms. 3. Persistent arthritis that affects at least one joint and interferes with quality of life or daily function. 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 service) or outside the normal limit, which in the opinion of the investigator are not clinically significant. The following lower limits are established as ceilings to allow the inclusion of patients: - Hemoglobin ≥ 8.5 g/L, value justified by RA activity. -Hematocrit 0.28 in women and 0.31 in men. -Leukocyte count ≤ 3000/L = 3 x 109/L. -Absolute neutrophil count ≥ 1500 / uL = 1.5 x 109 /L. -Platelet count ≥ 100000 /uL = 100 x 109 /L. 6. Express and written voluntariness by the patient to participate in the clinical trial, by signing the consent to participate

Exclusion criteria:

1. Clinical diagnosis of Chikungunya virus infection with an evolution time < 21 days (acute phase) or >90 days (chronic phase) 2. Complementary value of clinical laboratory outside the normal range and clinically relevant. 3. Ongoing treatment with Jusvinza. 4. History of allergy or known contraindication to the intervention product to be evaluated in the clinical trial. 5. Previous treatment with another biological therapy (< of 3 months) or ongoing. 6. Ongoing treatment with another investigational product. 7. Active concomitant infections that may explain joint symptoms (e.g., active tuberculosis). 8. Confirmed diagnosis of malignancy. 9. Confirmed diagnosis of congenital or acquired immunodeficiency. 10. Confirmed diagnosis of hematologic disease. (Acute or chronic leukosis, 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 comply with the questionnaires posed 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 avoid procreation (condom or vasectomy). 15. Pregnancy, puerperium or breastfeeding period.

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:

2

Target sample size:

174

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:

Leyanis

Last Name:

Hernandez Frometa

Specialty:

First degree specialist in Comprehensive General Medicine

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 e/ 158 y 190, Cubanacan, Playa, Apartado 6162

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

+53-72080428 ext 108

Email :

leyanis.hernandez@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:

First and Second degree specialist in Hygiene and Epidemiology

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 e/ 158 y 190, Cubanacan, Playa, Apartado 6162

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

+53-72080428 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:

"10 de Octubre" Clinical Surgical Teaching Hospital

Status of evaluation:

In review

Status of evaluation date of Ethic Committee:

13/11/2025

Postal address of Ethic Committee :

Calzada 10 de Octubre No. 130 e/Alejandro Ramírez y Agua Dulce. Cerro. ZC: 10300, Havana, Cuba

Telephone:

+53-78252292

Email:

manuel.hernandez@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

17/07/2026

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:

RPCEC00000465

Date of Registration in Primary Registry:

19/11/2025

Record Verification Date:

2025/11/19

Next update date:

2026/11/19

Link to the spanish version:

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Safety and therapeutic effect of administration of Jusvinza in the post-acute stage of Chikungunya infection

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