CT to Assess the Efficacy and Safety of Adding GMA to Infliximab in Paediatric Patients With Steroid-refractory Ulcerative Colitis

Study Purpose

The primary endpoint will be evaluated through the following variables: PUCAI score, IFX levels, and steroid treatment. Clinical response to IFX will be evaluated through the PUCAI score. The response will be considered clinically significant if PUCAI points continue maintained below 30 during the study period. The IFX response will also be determined by IFX serum levels. A therapeutic IFX level, i.e. for achieving an adequate clinical response, is established above 6 μg/mL. Finally, the necessity, or not, of a steroid treatment during the study period will also be indicative of successful efficacy with GMA.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients under 18 years of age and weighing ≥25 kg at the time of study initiation. 2. Patients with diagnosis of UC. 3. Patients who started IFX treatment due to the lack of response to corticosteroids following an UC flare-up (steroid-refractory UC). 4. Patients who have received IFX between 12 and 16 weeks prior to the study initiation. 5. Patients who have showed a clinical response to IFX at the time of study initiation (defined as a reduction of at least 15 points in PUCAI score and being maintained below 30 points). 6. Patients with therapeutic IFX blood levels (above 6 μg/mL) at the time of study initiation. 7. Patient´s legal guardian must be willing and able to give written informed consent, and the patient must be willing to give written informed assent (if applicable as determined by the Ethics Committee) and comply with the Study visit Schedule.

Exclusion Criteria:

1. Patients who have received another anti-TNF prior to entry in the study. 2. Patients with a peripheral circulation count of less than 2,000 granulocytes per μL. 3. Pregnant and lactating of childbearing potential patients. 4. Participation in another study or use of any experimental therapy within 30 days before day 1 of Study initiation.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05430412
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Adacyte Therapeutics SL
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Francisco Javier Martín de CarpiJorge Manuel Bastos Amil Dias
Principal Investigator Affiliation Hospital San Joan de DeuCHU Sao Joao
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Portugal, Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Study Website: View Trial Website
Additional Details

The trial has the following objectives: Primary objective (PO): The primary endpoint will be evaluated through the following variables: PUCAI score, IFX levels, and steroid treatment. Clinical response to IFX will be evaluated through the PUCAI score. The response will be considered clinically significant if PUCAI points continue maintained below 30 during the study period. The IFX response will also be determined by IFX serum levels. A therapeutic IFX level, i.e. for achieving an adequate clinical response, is established above 6 μg/mL. Finally, the necessity, or not, of a steroid treatment during the study period will also be indicative of successful efficacy with GMA. Secondary objectives (SO): 1. Quantification of IFX trough and ATI levels, and description of the IFX dose at baseline, 12 and 40 weeks of follow-up. 2. Measurement of PUCAI score at baseline, 12 and 40 weeks of follow-up. 3. Patients maintaining clinical response off steroids, 12 and 40 weeks of follow-up. 4. Patients experiencing flares-ups during the study period. 5. Quantification of fecal calprotectin level at baseline, 12 and 40 weeks of follow-up. Fecal calprotectin is associated with clinical remission with levels higher than 150 μg/g. 6. Measurement of C-reactive protein, erythrocyte sedimentation rate, hemoglobin, albumin, platelet levels at baseline, 12 and 40weeks of follow-up. 7. Quantification of leucocyte counts in peripheral blood at baseline, 12 and 40 weeks of followup. 8. Monitoring of AEs during the study period

Arms & Interventions

Arms

Experimental: Adacolumn

Adacolumn is a non-pharmacological treatment which reduces the inflammation by removing specifically targeted white blood cells from the blood circulation. The Adacolumn is designed to be used in combination with the Adamonitor and its Adastand, and the Adacircuit. The column has a capacity of 335 mL and is filled with cellulose acetate beads of 2 mm in diameter as the column adsorptive leukocytapheresis carriers. The carriers are bathed in 130 mL of sterile saline until use when the column is primed with additional sterile saline and then with heparinized saline prior to use. Patients will receive 10 sessions with Adacolumn. It would be reduced between 5 - 10, according to the patient´s response and following PI valuation. Patients will receive Adacolumn with IFX for that period of time. Patients will have received previously IFX for 12-16 weeks. visits will be conducted every week, for the application of Adacolumn.

Interventions

Device: - Adacolumn

The study will consist of 10 sessions of Adacolumn® treatment (once per week) and a follow-up period (from week 12 to week 40 since study inclusion).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital Coimbra, Coimbra, Portugal

Status

Not yet recruiting

Address

Hospital Coimbra

Coimbra, ,

Site Contact

Ricardo Ferreira

p.zapico@adacyte.com

34 687 975 712

Hospital Santa Maria, Lisboa, Portugal

Status

Not yet recruiting

Address

Hospital Santa Maria

Lisboa, ,

Site Contact

Ana Isabel Lopes

p.zapico@adacyte.com

34 687 975 712

Hospital Soa Joao, Oporto, Portugal

Status

Not yet recruiting

Address

Hospital Soa Joao

Oporto, ,

Site Contact

Eunice Trindade

p.zapico@adacyte.com

34 687 975 712

Hospital H. Sant Joan de Déu, Sant Joan Despí, Barcelona, Spain

Status

Recruiting

Address

Hospital H. Sant Joan de Déu

Sant Joan Despí, Barcelona,

Site Contact

Francisco Javier Martin Carpi

p.zapico@adacyte.com

34 687 975 712

Hospital Universitari Vall d'Hebron, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitari Vall d'Hebron

Barcelona, ,

Site Contact

Oscar Segarra

p.zapico@adacyte.com

34 687 975 712

Madrid, Spain

Status

Recruiting

Address

Hospital Infantil Universitario Niño Jesús

Madrid, ,

Site Contact

Marta Velasco Rodríguez-Belvis

p.zapico@adacyte.com

34 687 975 712

Málaga, Spain

Status

Recruiting

Address

Hospital Materno-Infantil del H.U.R. de Málaga

Málaga, ,

Site Contact

Víctor Manuel Navas López

p.zapico@adacyte.com

34 687 975 712

Complejo H. Regional Virgen Del Rocío, Sevilla, Spain

Status

Recruiting

Address

Complejo H. Regional Virgen Del Rocío

Sevilla, ,

Site Contact

Alejandro Rodriguez

p.zapico@adacyte.com

34 687 975 712

Hospital U. Ntra Señora de Candelaria, Tenerife, Spain

Status

Recruiting

Address

Hospital U. Ntra Señora de Candelaria

Tenerife, ,

Site Contact

José Ramón Alberto Alonso

p.zapico@adacyte.com

34 687 975 712

Hospital Universitari I Politècnic La Fe, Valencia, Spain

Status

Recruiting

Address

Hospital Universitari I Politècnic La Fe

Valencia, ,

Site Contact

Ester Donat

p.zapico@adacyte.com

34 687 975 712