Effect of DrugEarly Phase 1NCT06742606
Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease
A Early Phase 1 study testing Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab in people with Effect of Drug, run by Ain Shams University.
Trial summary
Compare efficacy of different biologicals in induction of remission including clinical, laboratory and histopathological remission. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 13 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients fulfilling modified Porto criteria for diagnosis of IBD including clinical features, laboratory, radiological and pathological findings.
- Patients initially severely diseased or in relapse and planned to start or change biological therapy.
Who cannot join
- Patients already on biological therapy and controlled. Patients with known humeral or cell mediated immunodeficiency.
- Ethical
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mohamed nageh abdelhamed, master degree in pediatrics contact
About this study
Compare efficacy of different biologicals in induction of remission including clinical, laboratory and histopathological remission.
Read the detailed description
IBD are multifactorial disorders characterized by chronic relapsing intestinal inflammation (Fousekis et al .,2021). Main subtypes of pediatric IBD are Crohn's disease (CD), ulcerative colitis (UC), and IBD unclassified (Corica \& Romano .., 2017) Mechanism of IBD involves uncontrolled immune mediated inflammatory response in genetically predisposed individuals to an unknown environmental trigger that interacts with gut microbiome and primarily affects gastrointestinal tract ( Iyer \& Corr ..,2021) Pediatric onset IBD is more aggressive and rapidly progressive disease compared to adult onset IBD. Nearly a quarter of all patients with IBD develop this disease during childhood (Moon .., 2019), mean age at diagnosis ranged from 4.5 to 16 years in pediatric cases (Mosli et al ..,2021) Rates of pediatric onset IBD continue to rise around the world (Kuenzig et al ..,2022 ).
In2018, the highest annual incidences of pediatric IBD were 23/100000 person in Europe, 15.2/100000 in North America, and 11.4/100000 in Asia/ Middle East and Oceania (Sýkora et al .., 2018) Pediatric IBD management and therapeutic approach can be chall enging, especially in younger patients (Romeo et al .., 2020 )). Biologic agents have revolutionized the treatment paradigm of pediatric IBD (Kapoor \& Crowley ..,2021) Biological drugs are monoclonal antibodies target specific cytokines involved in inflammatory cascade, such as tumour necrosis factor alpha (TNFα), integrins or interleukin 12/23, and have been approved for both pediatric CD and UC (Romeo et al 2020)
- Conditions
- Effect of Drug
- Being tested
- Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab
- Keywords
- biological therapy , IBD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumabBiological
All the patients will be treated according to guidelines of ECCO/ESPGHAN and will be followed up regularly for 12 months by assessment
- response to treatment Frequency of relapses,
Regular assessment will be:
Clinically every 2 to 4 weeks at gastroenterology outpatient clinic by using activity scoring systems:
pediatric Ulcerative Colitis Activity Index pediatric Chron's Disease Activity Index
Laboratory follow up will done at weeks 12,24,36,48 of starting or changing to other biological by doing inflammatory markers( CBC, ESR, CRP, albumin. At the end of study(week 48) each patient will be reassessed by:
Disease activity:
Laboratory Endoscopy will be repeated at week 48 of starting or changing to other biological to assess effect of biologicals on reach mucosal healing.
| Study group | Role | What they receive |
|---|---|---|
| patients diagnosed as IBD aged from 1 month to 16 years | Experimental | study will include 2 groups of pediatric IBD patients planned to start biological treatment or change to other biological therapy and each group formed of 20 patients Group
1 of patients will receive Adalimumab while Group 1 will receive ustekinumab Receives: Biological: Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare efficacy of different biologicals in induction of remission by histopathological remission using histological DCA scoring system
response to treatment Frequency of relapses, Control of symptoms and Following up growth pattern.
histopathological scoring assessment will be by using Inflammatory Bowel Disease-Distribution, Chronicity, Activity [IBD-DCA] Score
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start15 Jan 2025 (estimated)
- Primary completion13 Apr 2026 (estimated)
- Study completion13 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients diagnosed as IBD Inclusion Criteria: 1. Age: patients diagnosed as IBD aged from 1 month to 16 years 2. Patients fulfilling modified Porto criteria for diagnosis of IBD including clinical features, laboratory, radiological and pathological findings (Levine et al, 2014). 3. Patients initially severely diseased or in relapse and planned to start or change biological therapy. Exclusion Criteria: 1. Patients already on biological therapy and controlled. 2. Patients with known humeral or cell mediated immunodeficiency.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742606
- Sponsor's protocol ID
- biological therapy and IBD
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06742606
- Acronym / sponsor ID
- biological therapy and IBD
- Conditions
- Effect of Drug
- Keywords
- biological therapy , IBD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 13 Apr 2026 (estimated)
- Study completion
- 13 Dec 2026 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare efficacy of different biologicals in induction of remission including clinical, laboratory and histopathological remission.
Detailed description
IBD are multifactorial disorders characterized by chronic relapsing intestinal inflammation (Fousekis et al .,2021). Main subtypes of pediatric IBD are Crohn's disease (CD), ulcerative colitis (UC), and IBD unclassified (Corica \& Romano .., 2017) Mechanism of IBD involves uncontrolled immune mediated inflammatory response in genetically predisposed individuals to an unknown environmental trigger that interacts with gut microbiome and primarily affects gastrointestinal tract ( Iyer \& Corr ..,2021) Pediatric onset IBD is more aggressive and rapidly progressive disease compared to adult onset IBD. Nearly a quarter of all patients with IBD develop this disease during childhood (Moon .., 2019), mean age at diagnosis ranged from 4.5 to 16 years in pediatric cases (Mosli et al ..,2021) Rates of pediatric onset IBD continue to rise around the world (Kuenzig et al ..,2022 ).
In2018, the highest annual incidences of pediatric IBD were 23/100000 person in Europe, 15.2/100000 in North America, and 11.4/100000 in Asia/ Middle East and Oceania (Sýkora et al .., 2018) Pediatric IBD management and therapeutic approach can be chall enging, especially in younger patients (Romeo et al .., 2020 )). Biologic agents have revolutionized the treatment paradigm of pediatric IBD (Kapoor \& Crowley ..,2021) Biological drugs are monoclonal antibodies target specific cytokines involved in inflammatory cascade, such as tumour necrosis factor alpha (TNFα), integrins or interleukin 12/23, and have been approved for both pediatric CD and UC (Romeo et al 2020)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients diagnosed as IBD Inclusion Criteria: 1. Age: patients diagnosed as IBD aged from 1 month to 16 years 2. Patients fulfilling modified Porto criteria for diagnosis of IBD including clinical features, laboratory, radiological and pathological findings (Levine et al, 2014). 3. Patients initially severely diseased or in relapse and planned to start or change biological therapy. Exclusion Criteria: 1. Patients already on biological therapy and controlled. 2. Patients with known humeral or cell mediated immunodeficiency.
| Arm | Type | Receives |
|---|---|---|
| patients diagnosed as IBD aged from 1 month to 16 years | Experimental | Biological: Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumabstudy will include 2 groups of pediatric IBD patients planned to start biological treatment or change to other biological therapy and each group formed of 20 patients Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients fulfilling modified Porto criteria for diagnosis of IBD including clinical features, laboratory, radiological and pathological findings.
- Patients initially severely diseased or in relapse and planned to start or change biological therapy.
Key exclusion criteria (2 listed)
- Patients already on biological therapy and controlled. Patients with known humeral or cell mediated immunodeficiency.
- Ethical
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumabAll the patients will be treated according to guidelines of ECCO/ESPGHAN and will be followed up regularly for 12 months by assessment • response to treatment Frequency of relapses, Regular assessment will be: Clinically every 2 to 4 weeks at gastroenterology outpatient clinic by using activity scoring systems: pediatric Ulcerative Colitis Activity Index pediatric Chron's Disease Activity Index Laboratory follow up will done at weeks 12,24,36,48 of starting or changing to other biological by doing inflammatory markers( CBC, ESR, CRP, albumin. At the end of study(week 48) each patient will be reassessed by: Disease activity: Laboratory Endoscopy will be repeated at week 48 of starting or changing to other biological to assess effect of biologicals on reach mucosal healing. | Biological | patients diagnosed as IBD aged from 1 month to 16 years |
Primary outcome
Compare efficacy of different biologicals in induction of remission by histopathological remission using histological DCA scoring system
Time frame: 48 weeks
response to treatment Frequency of relapses, Control of symptoms and Following up growth pattern. histopathological scoring assessment will be by using Inflammatory Bowel Disease-Distribution, Chronicity, Activity [IBD-DCA] Score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed nageh abdelhamed, master degree in pediatrics contact
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab in people with Effect of Drug, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed nageh abdelhamed, master degree in pediatrics (hossam26620@gmail.com ext. 2001150181507), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare efficacy of different biologicals in induction of remission by histopathological remission using histological DCA scoring system (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.