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CXC Chemokine Receptor 1 (CXCR1) and CXCR2 Antagonist

Ladarixin for Type 1 Diabetes

Phase 3
Waitlist Available
Research Sponsored by Dompé Farmaceutici S.p.A
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Require, or has required at some time, insulin therapy through one or more separate subcutaneous injections or Continuous Subcutaneous Insulin Infusion (CSII)
Male and female patients aged 14-45 years, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 6, 12, 18, 24
Awards & highlights

Study Summary

This trial will test whether ladarixin can help preserve beta-cell function and delay progression of type 1 diabetes in adolescents and adults.

Who is the study for?
This trial is for adolescents and adults aged 14-45 with recent onset type 1 diabetes who are insulin-dependent. Participants must have some remaining beta-cell function, not be pregnant or breastfeeding, willing to use contraception, and free from significant cardiovascular disease, renal impairment, certain drug treatments (like CYP2C9 metabolized drugs), and immune system conditions.Check my eligibility
What is being tested?
The study tests if Ladarixin can preserve the pancreas's beta-cell function in type 1 diabetics better than a placebo. It also looks at how safe Ladarixin is for patients. The participants will either receive the actual medication or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects of Ladarixin aren't listed here, similar medications often cause issues like allergic reactions, liver problems indicated by increased enzymes in blood tests, digestive disturbances, potential kidney effects reflected in lab values (eGFR), and changes in heart rhythm (QTcF interval).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I use or have used insulin injections or a pump for my diabetes.
Select...
I am between 14 and 45 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 6, 12, 18, 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 6, 12, 18, 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in 2-hour AUC of C-peptide response to the Mixed Model Tolerance Test (MMTT)
Change from baseline in HbA1c
Secondary outcome measures
Average (previous 3 days) daily insulin requirement (IU/kg/day)
Change from baseline in 2-hour AUC of C-peptide response to the MMTT
Change in HbA1c from baseline
+6 more

Side effects data

From 2019 Phase 2 trial • 76 Patients • NCT02814838
28%
Headache
26%
Viral upper respiratory tract infection
12%
Dyspepsia
12%
Pyrexia
8%
Hypoglycaemia
8%
Oropharyngeal pain
6%
Arthralgia
6%
Abdominal pain upper
6%
Nausea
6%
Dizziness
6%
Upper respiratory tract infection
4%
Emotional distress
4%
Tooth extraction
4%
Insomnia
4%
Constipation
4%
Diarrhoea
4%
Hyperchlorhydria
4%
Vomiting
4%
Oral herpes
4%
Urinary tract infection
4%
Aspartate aminotransferase increased
4%
Dysmenorrhoea
2%
Ear discomfort
2%
Fall
2%
Nipple inflammation
2%
Asthma
2%
Ear pain
2%
Ligament sprain
2%
abdominal discomfort
2%
mental disorder
2%
Joint injury
2%
Muscle injury
2%
Syncope
2%
Anaemia
2%
Alanine aminotransferase increased
2%
Iron deficiency anaemia
2%
Skin wound
2%
Contusion
2%
Neutropenia
2%
Depression
2%
Migrane
2%
Glycosylated haemoglobin increased
2%
Alopecia
2%
Hyperglycaemia
2%
Drug hypersensitivity
2%
Acne
2%
Abdominal pain
2%
Eosinophilia
2%
Dental caries
2%
Gatroesophageal reflux disease
2%
Folliculitis
2%
Hypercholesterolaemia
2%
Back pain
2%
Lymphadenopathy
2%
Dysphagia
2%
Faeces hard
2%
Odynophagia
2%
Pancreatitis chronic
2%
Asthenia
2%
Fatigue
2%
Sensation of foreign body
2%
Cystitis
2%
Ear infection
2%
Eye infection
2%
Gastroenteritis
2%
Gastroeteritis viral
2%
Gingivitis
2%
Infected bite
2%
Iron deficiency
2%
Muscle spasms
2%
Myalgia
2%
Osteoarthritis
2%
Toothache
2%
Laryngitis
2%
Pharyngitis
2%
Tinea pedis
2%
Tonsillitis
2%
Tooth abscess
2%
Gastrointestinal disorder
2%
Clavicle fracture
2%
Viral infection
2%
Alcohol poisoning
2%
Cough
2%
Increased viscosity of upper respiratiory secretion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ladarixin
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LadarixinExperimental Treatment1 Intervention
400 mg b.i.d. for 13 cycles of 14 days on/14 days off
Group II: PlaceboPlacebo Group1 Intervention
matching placebo b.i.d. for 13 cycles of 14 days on/14 days off
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ladarixin
2016
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

Dompé Farmaceutici S.p.ALead Sponsor
49 Previous Clinical Trials
4,207 Total Patients Enrolled
Enrico Minnella, MDStudy DirectorDompé Farmaceutici
2 Previous Clinical Trials
592 Total Patients Enrolled
Annarita Maurizi, MDStudy DirectorDompé Farmaceutici

Media Library

Ladarixin (CXC Chemokine Receptor 1 (CXCR1) and CXCR2 Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04628481 — Phase 3
Type 1 Diabetes Research Study Groups: Ladarixin, Placebo
Type 1 Diabetes Clinical Trial 2023: Ladarixin Highlights & Side Effects. Trial Name: NCT04628481 — Phase 3
Ladarixin (CXC Chemokine Receptor 1 (CXCR1) and CXCR2 Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04628481 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients who are 20 years or older eligible for this clinical trial?

"This particular clinical trial is meant for patients who are young adults, specifically between the ages of 14 to 45. However, there are a total of 221 medical studies for patients who are younger than 18 and 966 for patients who are older than 65."

Answered by AI

What are the end goals of this research?

"The primary outcome for this trial, which will be measured at Month 12, is change from baseline in HbA1c levels. HbA1c is a diagnostic test for diabetes that measures levels of glycosylated hemoglobin. This trial will also be evaluating secondary outcomes including change in HbA1c from baseline, change from baseline in 2-hour AUC of C-peptide response to the MMTT, and estimated glucose disposal rate (eGDR)."

Answered by AI

Could you please sketch out the prior research on Ladarixin?

"At this moment, there are 2 Ladarixin clinical trials running. One of these is in Phase 3. Though the majority of Ladarixin trials are based in Ludwigshafen am Rhein, Germany, there are a total of 81 study centres located around the world."

Answered by AI

Has the FDA cleared Ladarixin for use?

"There is some evidence for both efficacy and safety of Ladarixin, as this is a Phase 3 trial."

Answered by AI

Is this study taking place in many different hospitals across North America?

"There are 23 centres currently running this trial, with additional locations in Atlanta, Chicago, Philadelphia and other parts of the country. If you are considering enrolling, it may be advantageous to select a clinic close to you to limit travel."

Answered by AI

Who does this trial require as participants?

"This study is recruiting 327 participants with diabetes, autoimmune aged 14 and 45. Most importantly, patients are required to meet the following criteria: Recent onset T1D (1st IMP dose within 180 days from 1st insulin administration);, Positive for at least one diabetes-related auto-antibody (anti-GAD; IAA, if obtained within 10 days of the onset of insulin therapy; IA-2 antibody; ZnT8);, Require, or has required at some time, insulin therapy through one or more separate subcutaneous injections or Continuous Subcutaneous Insulin Infusion (CSII)."

Answered by AI

Are people currently signing up for this experiment?

"The listed clinical study is actively looking for volunteers. The original posting date was December 21, 2020 with the latest update on October 18, 2022."

Answered by AI

What is the total number of participants in this clinical trial?

"In order for this clinical trial to be completed, 327 participants who fit the bill in terms of specified inclusion criteria are required. These patients can come from various clinical trial sites, such as Atlanta Diabetes Associates (ADA) in Atlanta, Georgia and The University of Chicago in Chicago, Illinois."

Answered by AI

Does this research break new ground?

"Ladarixin has been under investigation since 2020. The very first trial was conducted in 2020 and sponsored by Dompé Farmaceutici S.p.A. After the 2020 study, which had 25 participants, Ladarixin received approval to enter Phase 2 clinical trials. Currently, there are 2 ongoing studies involving Ladarixin in 24 metropolises and 8 countries."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function
2020. "A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04628481.
~65 spots leftby Mar 2025
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