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CXC Chemokine Receptor 1 (CXCR1) and CXCR2 Antagonist

Ladarixin for Type 1 Diabetes

Phase 2
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
Must not have
A history of significant cardiovascular disease/abnormality
Hepatic dysfunction defined by increased ALT/AST > 3 x upper limit of normal (ULN) and increased total bilirubin > 3 mg/dL [>51.3 μmol/L]
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 6, 12, 18, 24

Summary

This trial is testing ladarixin, a medication that may help protect insulin-producing cells in the pancreas. It targets adolescents and adults who have been diagnosed with type 1 diabetes, especially those with severe cases. The goal is to see if ladarixin can slow down the progression of the disease and keep these cells working longer.

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.
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.
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
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I use or have used insulin injections or a pump for my diabetes.
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I am between 14 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of serious heart disease.
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My liver tests show high enzyme levels and bilirubin.
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I am not taking medications like warfarin or certain diabetes drugs.
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My kidney function is moderately to severely reduced.
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I haven't taken any immunosuppressive drugs or experimental treatments in the past month.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in 2-hour AUC of C-peptide response to the Mixed Model Tolerance Test (MMTT)
Secondary study objectives
Additional Glucose Variability Indices derived from CGM
Additional Glucose Variability Indices derived from CONGA-n
Additional Glucose Variability Indices derived from MAGE
+5 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%
Insomnia
4%
Tooth extraction
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%
Ear pain
2%
abdominal discomfort
2%
Drug hypersensitivity
2%
Contusion
2%
Fall
2%
Joint injury
2%
Ligament sprain
2%
Muscle injury
2%
Skin wound
2%
Alanine aminotransferase increased
2%
Glycosylated haemoglobin increased
2%
Hyperglycaemia
2%
mental disorder
2%
Anaemia
2%
Iron deficiency anaemia
2%
Migrane
2%
Syncope
2%
Depression
2%
Nipple inflammation
2%
Asthma
2%
Acne
2%
Alopecia
2%
Neutropenia
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Type 1 Diabetes (T1D) primarily aim to preserve beta-cell function and manage blood glucose levels. Insulin therapy remains the cornerstone, replacing the insulin that the body can no longer produce. Immunomodulatory therapies, such as IL-8 receptor antagonists like Ladarixin, are being studied for their potential to reduce inflammation and preserve beta-cell function, thereby delaying disease progression. Combination therapies that include immunomodulators and agents that stimulate beta-cell regeneration are also promising, as they address both the autoimmune and regenerative aspects of T1D. These treatments are crucial for T1D patients as they offer the potential to maintain endogenous insulin production and improve long-term glycemic control, reducing the risk of complications.
Cardiovascular effects of GLP-1 receptor agonism.Reducing Type 1 Diabetes Mortality: Role for Adjunctive Therapies?Molecular Mechanism of the Effect of Huanglian Jiedu Decoction on Type 2 Diabetes Mellitus Based on Network Pharmacology and Molecular Docking.

Find a Location

Who is running the clinical trial?

Dompé Farmaceutici S.p.ALead Sponsor
51 Previous Clinical Trials
4,251 Total Patients Enrolled
Enrico Minnella, MDStudy DirectorDompé Farmaceutici
3 Previous Clinical Trials
475 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 2
Type 1 Diabetes Research Study Groups: Ladarixin, Placebo
Type 1 Diabetes Clinical Trial 2023: Ladarixin Highlights & Side Effects. Trial Name: NCT04628481 — Phase 2
Ladarixin (CXC Chemokine Receptor 1 (CXCR1) and CXCR2 Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04628481 — Phase 2
~29 spots leftby Dec 2025