A Phase 2 interventional study of Ladarixin and Placebo in Recent Onset type1 Diabetes, sponsored by Dompé Farmaceutici S.p.A. Terminated at 57 sites in 8 countries. Open to participants aged 14 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Dompé Farmaceutici S.p.A · Phase 2, Interventional, and Treatment
Objectives The objective of this clinical trial is to assess whether ladarixin treatment has an effect to preserve β-cell function and delay the progression of T1D in adolescent and adult patients.
The safety of ladarixin in the specific clinical setting will be also evaluated.
The study will be a phase 2, multicenter, double-blind, placebo-controlled study. It will randomize approximately 130-140 patients (with up to an estimated 15-20% adolescents), with recent onset (within 180 days from 1st insulin administration) type 1 diabetes (T1D), assigned (2:1) to receive either oral ladarixin treatment (400 mg b.i.d. for 13 cycles of 14 days on/14 days off - treatment group) or placebo (control group). Recruitment will be competitive among the study sites, until the planned number of patients is randomized.
Ladarixin and placebo will be both administered for 1 year. All patients will be followed-up for 24 months from the 1st administration of the study medication. After the initial 12-m treatment period, all patients will enter into a 12-month follow-up (total period 24-month after first IMP administration). The study database (DB) will be locked when the last randomized patient has completed the month 12 visit (or being lost in follow-up), and relative data have been fully reconciled and cleaned; at that point, the DB will be unblinded and all endpoints, including the 6-month primary endpoint, will be analyzed, and the follow-up will continue under open-label conditions up to month 24.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's enrollment of 289 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Dompé Farmaceutici S.p.A is the lead sponsor of 52 studies on the registry; 4 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 18 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
400 mg b.i.d. for 13 cycles of 14 days on/14 days off
Drug: Ladarixin
matching placebo b.i.d. for 13 cycles of 14 days on/14 days off
Drug: Placebo
Oral ladarixin twice a day for 13 cycles
Also known as: allosteric inhibitor of CXCL8 (IL-8), CXCR1 and CXCR2 receptors
Oral placebo twice a day for 13 cycles
Change From Baseline in 2-hour Area Under the Concentration-time Curve (AUC) of C-peptide Response to the Mixed Model Tolerance Test (MMTT)
Change from baseline in the 2-hour C-peptide Area Under the Curve (AUC) following a Mixed-Meal Tolerance Test (MMTT) at Month 6. The analysis used an adjusted ANCOVA model with the change from baseline in log(AUC + 1) as the dependent variable. Qualitative independent variables included treatment group, age group, sex, and BMI group, with the baseline value as a quantitative covariate. Missing data at Month 6 were handled via multiple imputation using a retrieved dropout approach. Missing values were imputed using a regression model based on the participant's allocated treatment arm and baseline value, utilizing data from participants who discontinued treatment but completed the Month 6 measurement. Baseline is defined as the last visit prior to randomization. Change from Baseline is defined as post-baseline visit value minus baseline visit value. The adjusted mean along with its the corresponding 95% confidence interval (CI) has been presented.
Time frame: Baseline and at Month 6
Change From Baseline in 2-hour AUC of C-peptide Response to the MMTT at Months 12, 18, and 24
Change from baseline in the 2-hour C-peptide AUC following a MMTT at Months 6, 12, and 18. The analysis used an adjusted ANCOVA model with the change from baseline in log(AUC + 1) as the dependent variable. Qualitative independent variables included treatment group, age group, sex, and BMI group, with the baseline value as a quantitative covariate. Missing data at Months 12, 18 and 24 were handled via multiple imputation using a retrieved dropout approach. Missing values were imputed using a regression model based on the participant's allocated treatment arm and baseline value, utilizing data from participants who discontinued treatment but completed the measurement at the timepoint of interest. Intermediate timepoints were included as covariates in the model. Baseline is defined as the last visit prior to randomization. Change from Baseline is defined as post-baseline visit value minus baseline visit value.
Time frame: Baseline and at Months 12, 18, and 24
Change in Glycated Hemoglobin (HbA1c) From Baseline
The change from baseline in HbA1c was analyzed using an adjusted ANCOVA model. The dependent variable is the change from baseline in HbA1c at each respective time point, with treatment, age group, sex, and BMI group as qualitative independent variables and the baseline value as a quantitative covariate. . Missing data are addressed via Multiple Imputation (MI) using a retrieved dropout approach, where values are imputed based on a regression model incorporating treatment arm, baseline value, and intermediate assessments as covariates. Baseline is defined as the last visit prior to randomization. Change from Baseline is defined as post-baseline visit value minus baseline visit value. The adjusted mean along with its the corresponding 95% confidence interval (CI) has been presented.
Time frame: Baseline and at Months 6, 12, 18 and 24
Percentage of Participants With HbA1c <7% Who Did Not Experience Severe Hypoglycemic Events During Treatment
The proportion of participants with HbA1c \< 7% was calculated by timepoint: the numerator was the number of participants with events occurring at a specific timepoint (month X visit), without cumulating participants with events up to that timepoint. Participants with severe hypoglycemic events were considered cumulatively and only events up to month 12 were considered (condition was evaluated by considering treatment period only). If HbA1c ≥ 7% or the participant had experienced a severe hypoglycemic event, then the endpoint was equal to "No" even in the case of one missing component. If either the HbA1c or severe hypoglycemic event data was missing, but the other satisfied the criteria for the endpoint, then the response to the endpoint was missing.
Time frame: At Months 6, 12, 18, and 24
Average (Previous 3 Days) Daily Insulin Requirement International Units Per Kilogram Per Day (IU/kg/Day)
The average daily insulin requirement at each visit was calculated from the daily insulin requirement measured at the 3 days prior to the visit.
Time frame: At Months 6, 12, 18, and 24
Percentage of Participants With HbA1c <7% and Daily Insulin Requirement <0.5 IU/kg/Day
Percentage of participants with HbA1c \<7% and daily insulin requirement \<0.5 (IU/Kg/day) was calculated for each time point, the numerator is the number of participants in each treatment group with events occurring at a specific timepoint, and the denominator is the number of participants in each treatment group reaching the specific visit.
Time frame: At Months 6, 12, 18, and 24
Number of Self-reported Episodes of Severe Hypoglycemia
This outcome assessed the total number of self-reported episodes of severe hypoglycemia occurring across all participants.
Time frame: Post-baseline up to Month 24
Percentage of Patients Not Requiring Insulin Therapy
This outcome assessed the percentage of participants who did not require an insulin therapy at the timepoint of interest.
Time frame: Months 6, 12, 18 and 24
Estimated Glucose Disposal Rate (eGDR)
Estimated Glucose Disposal Rate (eGDR) is a marker for the Assessment of Insulin Resistance and a validated clinical tool for estimating insulin sensitivity in type 1 diabetes. The eGDR was calculated using a formula incorporating Glycated Hemoglobin (HbA1c), hypertension status (blood pressure), and the Waist-to-Hip Ratio (WHR), with results expressed in milligrams per kilogram per minute (mg/kg/min).
Time frame: Months 6, 12, 18, and 24
A total of 141 participants were randomized in the study and 140 participants received treatment.
| Milestone | Ladarixin | Placebo | Run-in |
|---|---|---|---|
| Started | 0 | 0 | 289 |
| Completed | 0 | 0 | 141 |
| Not completed | 0 | 0 | 148 |
| Withdrew: Failure to meet continuation criteria | 0 | 0 | 131 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Physician decision | 0 | 0 | 1 |
| Withdrew: Protocol-specific withdrawal criterion met | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 14 |
| Milestone | Ladarixin | Placebo | Run-in |
|---|---|---|---|
| Started | 95 | 46 | 0 |
| Completed | 65 | 26 | 0 |
| Not completed | 30 | 20 | 0 |
| Withdrew: Discontinuation criteria met | 2 | 0 | 0 |
| Withdrew: Lost to follow-up | 3 | 2 | 0 |
| Withdrew: Withdrawal by subject | 14 | 12 | 0 |
| Withdrew: Physician decision | 1 | 1 | 0 |
| Withdrew: Pregnancy | 2 | 0 | 0 |
| Withdrew: Unavailable due to travel (abroad) | 1 | 3 | 0 |
| Withdrew: Study terminated by sponsor | 7 | 2 | 0 |
Change from baseline in the 2-hour C-peptide Area Under the Curve (AUC) following a Mixed-Meal Tolerance Test (MMTT) at Month 6. The analysis used an adjusted ANCOVA model with the change from baseline in log(AUC + 1) as the dependent variable. Qualitative independent variables included treatment group, age group, sex, and BMI group, with the baseline value as a quantitative covariate. Missing data at Month 6 were handled via multiple imputation using a retrieved dropout approach. Missing values were imputed using a regression model based on the participant's allocated treatment arm and baseline value, utilizing data from participants who discontinued treatment but completed the Month 6 measurement. Baseline is defined as the last visit prior to randomization. Change from Baseline is defined as post-baseline visit value minus baseline visit value. The adjusted mean along with its the corresponding 95% confidence interval (CI) has been presented.
| nanomole*hour/Liter (nmol*hr/L) | Ladarixin | Placebo |
|---|---|---|
| Change From Baseline in 2-hour Area Under the Concentration-time Curve (AUC) of C-peptide Response to the Mixed Model Tolerance Test (MMTT) | -0.284 (-0.453 to -0.114) | -0.151 (-0.373 to 0.071) |
Change from baseline in the 2-hour C-peptide AUC following a MMTT at Months 6, 12, and 18. The analysis used an adjusted ANCOVA model with the change from baseline in log(AUC + 1) as the dependent variable. Qualitative independent variables included treatment group, age group, sex, and BMI group, with the baseline value as a quantitative covariate. Missing data at Months 12, 18 and 24 were handled via multiple imputation using a retrieved dropout approach. Missing values were imputed using a regression model based on the participant's allocated treatment arm and baseline value, utilizing data from participants who discontinued treatment but completed the measurement at the timepoint of interest. Intermediate timepoints were included as covariates in the model. Baseline is defined as the last visit prior to randomization. Change from Baseline is defined as post-baseline visit value minus baseline visit value.
| nmol*hr/L | Ladarixin | Placebo |
|---|---|---|
| Month 12 | -0.426 (-0.767 to -0.084) | -0.447 (-0.948 to 0.054) |
| Month 18 | -0.574 (-0.991 to -0.157) | -0.524 (-1.163 to 0.114) |
| Month 24 | -0.661 (-8.201 to 6.880) | -0.843 (-14.345 to 12.660) |
The change from baseline in HbA1c was analyzed using an adjusted ANCOVA model. The dependent variable is the change from baseline in HbA1c at each respective time point, with treatment, age group, sex, and BMI group as qualitative independent variables and the baseline value as a quantitative covariate. . Missing data are addressed via Multiple Imputation (MI) using a retrieved dropout approach, where values are imputed based on a regression model incorporating treatment arm, baseline value, and intermediate assessments as covariates. Baseline is defined as the last visit prior to randomization. Change from Baseline is defined as post-baseline visit value minus baseline visit value. The adjusted mean along with its the corresponding 95% confidence interval (CI) has been presented.
| percentage of glycosylated hemoglobin | Ladarixin | Placebo |
|---|---|---|
| Month 6 | 0.500 (-0.668 to 1.667) | 0.032 (-1.881 to 1.944) |
| Month 12 | -0.267 (-0.681 to 0.148) | -0.280 (-0.779 to 0.219) |
| Month 18 | -0.031 (-0.713 to 0.652) | -0.180 (-1.074 to 0.714) |
| Month 24 | -0.007 (-1.383 to 1.369) | 0.080 (-1.823 to 1.982) |
The proportion of participants with HbA1c \< 7% was calculated by timepoint: the numerator was the number of participants with events occurring at a specific timepoint (month X visit), without cumulating participants with events up to that timepoint. Participants with severe hypoglycemic events were considered cumulatively and only events up to month 12 were considered (condition was evaluated by considering treatment period only). If HbA1c ≥ 7% or the participant had experienced a severe hypoglycemic event, then the endpoint was equal to "No" even in the case of one missing component. If either the HbA1c or severe hypoglycemic event data was missing, but the other satisfied the criteria for the endpoint, then the response to the endpoint was missing.
| percentage of participants | Ladarixin | Placebo |
|---|---|---|
| Month 6 | 44.3 | 55.6 |
| Month 12 | 46.2 | 39.4 |
| Month 18 | 44.1 | 48.3 |
| Month 24 | 41.0 | 40.9 |
The average daily insulin requirement at each visit was calculated from the daily insulin requirement measured at the 3 days prior to the visit.
| IU/Kg/Day | Ladarixin | Placebo |
|---|---|---|
| Month 6 | 0.39 ± 0.23 | 0.34 ± 0.17 |
| Month 12 | 0.41 ± 0.23 | 0.39 ± 0.18 |
| Month 18 | 0.43 ± 0.22 | 0.47 ± 0.27 |
| Month 24 | 0.47 ± 0.20 | 0.46 ± 0.23 |
Percentage of participants with HbA1c \<7% and daily insulin requirement \<0.5 (IU/Kg/day) was calculated for each time point, the numerator is the number of participants in each treatment group with events occurring at a specific timepoint, and the denominator is the number of participants in each treatment group reaching the specific visit.
| percentage of participants | Ladarixin | Placebo |
|---|---|---|
| Month 6 | 59.3 | 61.1 |
| Month 12 | 58.2 | 48.5 |
| Month 18 | 57.4 | 44.8 |
| Month 24 | 43.8 | 37.5 |
This outcome assessed the total number of self-reported episodes of severe hypoglycemia occurring across all participants.
| Number of events | Ladarixin | Placebo |
|---|---|---|
| Number of Self-reported Episodes of Severe Hypoglycemia | 278 | 76 |
This outcome assessed the percentage of participants who did not require an insulin therapy at the timepoint of interest.
| percentage of participants | Ladarixin | Placebo |
|---|---|---|
| Month 6 | 1.2 | 0 |
| Month 12 | 0 | 2.8 |
| Month 18 | 0 | 3.2 |
| Month 24 | 0 | 4.0 |
Estimated Glucose Disposal Rate (eGDR) is a marker for the Assessment of Insulin Resistance and a validated clinical tool for estimating insulin sensitivity in type 1 diabetes. The eGDR was calculated using a formula incorporating Glycated Hemoglobin (HbA1c), hypertension status (blood pressure), and the Waist-to-Hip Ratio (WHR), with results expressed in milligrams per kilogram per minute (mg/kg/min).
| mg/kg/min | Ladarixin | Placebo |
|---|---|---|
| Month 6 | 9.56 ± 3.01 | 8.26 ± 4.52 |
| Month 12 | 9.37 ± 3.14 | 7.89 ± 4.77 |
| Month 18 | 9.64 ± 2.87 | 8.78 ± 2.34 |
| Month 24 | 9.29 ± 3.36 | 8.72 ± 3.17 |
Collected over Up to Month 24. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ladarixin | 0/94 (0%) | 1/94 (1.1%) | 71/94 (75.5%) |
| Placebo | 0/46 (0%) | 1/46 (2.2%) | 33/46 (71.7%) |
| Run-in | 0/289 (0%) | 0/289 (0%) | 10/289 (3.5%) |
| Event | Ladarixin | Placebo | Run-in |
|---|---|---|---|
| GastroenteritisInfections and infestations | 0/94 | 1/46 | 0/289 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/94 | 0/46 | 0/289 |
| Event | Ladarixin | Placebo | Run-in |
|---|---|---|---|
| COVID-19Infections and infestations | 25/94 | 9/46 | 1/289 |
| NasopharyngitisInfections and infestations | 17/94 | 3/46 | 1/289 |
| DyspepsiaGastrointestinal disorders | 17/94 | 1/46 | 0/289 |
| PyrexiaGeneral disorders | 11/94 | 2/46 | 1/289 |
| HypoglycaemiaMetabolism and nutrition disorders | 11/94 | 3/46 | 5/289 |
| Upper respiratory tract infectionInfections and infestations | 10/94 | 3/46 | 0/289 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 9/94 | 0/46 | 0/289 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/94 | 4/46 | 0/289 |
| InfluenzaInfections and infestations | 8/94 | 2/46 | 0/289 |
| HeadacheNervous system disorders | 8/94 | 3/46 | 0/289 |
Full analysis set (FAS), consisting of all participants who were randomized and received at least one dose of investigational product.
| Age, Continuous(years) | Ladarixin | Placebo | Total |
|---|---|---|---|
| Mean | 26.4 ± 8.1 | 26.2 ± 8.8 | 26.4 ± 8.3 |
| Sex: Female, Male(Participants) | Ladarixin | Placebo | Total |
|---|---|---|---|
| Female | 37 | 9 | 46 |
| Male | 57 | 37 | 94 |
| Race/Ethnicity, Customized(Participants) | Ladarixin | Placebo | Total |
|---|---|---|---|
| Black or African American | 2 | 0 | 2 |
| White | 92 | 42 | 134 |
| Other | 0 | 1 | 1 |
| Multiple | 0 | 2 | 2 |
| American Indian or Alaska Native | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ladarixin