Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight (ADJUST)

April 21, 2026 updated by: LEO Pharma

Adjustable Brodalumab Dosage Regimen Compared With Standard Brodalumab Treatment for 52 Weeks in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight

This study investigates if an adjusted brodalumab dosage regimen will give improved efficacy in psoriasis in patients with a body weight of over 120 kg. The increased dosage regimen will be compared to the standard brodalumab treatment plus placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Brodalumab is an anti-IL-17 receptor antibody and blocks the inflammatory effects of IL-17 in the skin. Some psoriasis patients with a higher body weight experienced a lower treatment effect of brodalumab in clinical studies. Therefore, the purpose of this study is to investigate if increasing the dose of brodalumab will increase the effect of treatment for patients with a higher body weight. The study will run over 60-62 weeks, including screening, treatment period and safety follow-up, with the primary endpoint measurement at Week 40. Patients will receive subcutaneous injections of brodalumab at Week 0, 1, and 2, followed by injections every 2 weeks. Participants not fulfilling a predefined response at any time after Week 16 will receive a dose adjustment to 280 mg brodalumab or 210 mg brodalumab plus placebo every 2 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
385

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • LEO Pharma Investigational Site
      • Ham-sur-Heure-Nalinnes, Belgium, 6120
        • LEO Pharma Investigational Site
      • Leuven, Belgium, 3000
        • LEO Pharma Investigational Site
      • Liège, Belgium, B-4000
        • LEO Pharma Investigational Site
  • Czechia
      • Kutná Hora, Czechia, 284 01
        • LEO Pharma Investigational Site
      • Nový Jičín, Czechia, 741 01
        • LEO Pharma Investigational Site
      • Plzen-Bory, Czechia, 305 99
        • LEO Pharma Investigational Site
  • France
      • Saint-Priest-en-Jarez, France, 42270
        • LEO Pharma Investigational Site
      • Toulouse, France, 31059
        • LEO Pharma Investigational Site
      • Valence, France, 13616
        • LEO Pharma Investigational Site
    • Somme
      • Amiens, Somme, France, 80054
        • LEO Pharma Investigational Site
  • Germany
      • Bad Bentheim, Germany, 48455
        • LEO Pharma Investigational Site
      • Bielefeld, Germany, 33647
        • LEO Pharma Investigational Site
      • Hamburg, Germany, 20246
        • LEO Pharma Investigational Site
      • Memmingen, Germany, 87700
        • LEO Pharma Investigational Site
      • Münster, Germany, 48149
        • LEO Pharma Investigational Site
      • Oldenburg, Germany, 26133
        • LEO Pharma Investigational Site
      • Osnabrück, Germany, 49074
        • LEO Pharma Investigational Site
    • Baden-Wurttemberg
      • Langenau, Baden-Wurttemberg, Germany, 89129
        • LEO Pharma Investigational Site
    • Hesse
      • Limburg an der Lahn, Hesse, Germany, 56242
        • LEO Pharma Investigational Site
      • Wiesbaden, Hesse, Germany, 65189
        • LEO Pharma Investigational Site
    • Lower Saxony
      • Lohne, Lower Saxony, Germany, 49393
        • LEO Pharma Investigational Site
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55128
        • LEO Pharma Investigational Site
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • LEO Pharma Investigational Site
    • State of Berlin
      • Berlin, State of Berlin, Germany, 10117
        • LEO Pharma Investigational Site
  • Greece
      • Athens, Greece, 115 25
        • LEO Pharma Investigational Site
      • Athens, Greece, 16121
        • LEO Pharma Investigational Site
      • Piraeus, Greece, 185 36
        • LEO Pharma Investigational Site
      • Thessaloniki, Greece, 54643
        • LEO Pharma Investigational Site
      • Thessaloniki, Greece, 546 43
        • LEO Pharma Investigational Site
      • Thessaloniki, Greece, 56403
        • LEO Pharma Investigational Site
    • Crete
      • Heraklion, Crete, Greece, 711 10
        • LEO Pharma Investigational Site
  • Hungary
      • Debrecen, Hungary, 4032
        • LEO Pharma Investigational Site
      • Orosháza, Hungary, 5900
        • LEO Pharma Investigational Site
      • Szolnok, Hungary, 5000
        • LEO Pharma Investigational Site
      • Veszprém, Hungary, 8200
        • LEO Pharma Investigational Site
  • Italy
      • Ancona, Italy, 60020
        • LEO Pharma Investigational Site
      • Bologna, Italy, 40138
        • LEO Pharma Investigational Site
      • Brescia, Italy, 25123
        • LEO Pharma Investigational Site
      • Coppito, Italy, 67100
        • LEO Pharma Investigational Site
      • Modena, Italy, 41124
        • LEO Pharma Investigational Site
      • Naples, Italy, 80131
        • LEO Pharma Investigational Site
      • Parma, Italy, 43126
        • LEO Pharma Investigational Site
      • Pavia, Italy, 27100
        • LEO Pharma Investigational Site
      • Roma, Italy, 00168
        • LEO Pharma Investigational Site
      • Roma, Italy, 00133
        • LEO Pharma Investigational Site
      • Rozzano, Italy, 20089
        • LEO Pharma Investigational Site
  • Netherlands
      • Beek, Netherlands, 6191 JW
        • LEO Pharma Investigational Site
  • Poland
      • Iwonicz-Zdrój, Poland, 38-440
        • LEO Pharma Investigational Site
      • Lodz, Poland, 90-436
        • LEO Pharma Investigational Site
      • Lodz, Poland, 90-242
        • LEO Pharma Investigational Site
      • Lublin, Poland, 20-362
        • LEO Pharma Investigational Site
      • Lublin, Poland, 20-412
        • LEO Pharma Investigational Site
      • Poznan, Poland, 60-529
        • LEO Pharma Investigational Site
      • Skierniewice, Poland, 96-100
        • LEO Pharma Investigational Site
      • Warsaw, Poland, 02-482
        • LEO Pharma Investigational Site
      • Warsaw, Poland, 02-758
        • LEO Pharma Investigational Site
      • Warsaw, Poland, 02-801
        • LEO Pharma Investigational Site
      • Wroclaw, Poland, 50-566
        • LEO Pharma Investigational Site
      • Wroclaw, Poland, 51-318
        • LEO Pharma Investigational Site
      • Wroclaw, Poland, 52-416
        • LEO Pharma Investigational Site
  • Spain
      • Alicante, Spain, 03010
        • LEO Pharma Investigational Site
      • Badalona, Spain, 08916
        • LEO Pharma Investigational Site
      • Barcelona, Spain, 08025
        • LEO Pharma Investigational Site
      • Barcelona, Spain, 08035
        • LEO Pharma Investigational Site
      • Granada, Spain, 18014
        • LEO Pharma Investigational Site
      • Manises, Spain, 46940
        • LEO Pharma Investigational Site
      • Pontevedra, Spain, 36001
        • LEO Pharma Investigational Site
      • Pozuelo de Alarcón, Spain, 28223
        • LEO Pharma Investigational Site
      • Santiago de Compostela, Spain, 15706
        • LEO Pharma Investigational Site
      • Valencia, Spain, 46014
        • LEO Pharma Investigational Site
      • Villajoyosa, Spain, 03570
        • LEO Pharma Investigational Site
  • United Kingdom
      • Chorley, United Kingdom, PR7 7NA
        • LEO Pharma Investigational Site
      • Corby, United Kingdom, NN17 2UR
        • LEO Pharma Investigational Site
      • Corby, United Kingdom, NN18 9EZ
        • LEO Pharma Investigational Site
      • Coventry, United Kingdom, CV3 4FJ
        • LEO Pharma Investigational Site
      • Liverpool, United Kingdom, L22 0LG
        • LEO Pharma Investigational Site
      • London, United Kingdom, BR5 3QG
        • LEO Pharma Investigational Site
      • London, United Kingdom, E1 2ES
        • LEO Pharma Investigational Site
      • Northwood, United Kingdom, HA6 2RN
        • LEO Pharma Investigational Site
      • Shipley, United Kingdom, BD18 35A
        • LEO Pharma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Signed and dated informed consent has been obtained prior to any protocol-related procedures.
  • Age ≥18 to <75 years at the time of screening.
  • Diagnosed with chronic plaque psoriasis at least 6 months before randomisation.
  • Body weight ≥120 kg at the time of screening.
  • Moderate-to-severe plaque psoriasis as defined by: BSA ≥10% and PASI ≥12 at screening and baseline.
  • No evidence of active or latent tuberculosis according to local standard of care.

Key Exclusion Criteria:

  • Diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g., eczema) that would interfere with evaluations of the effect of the investigational medicinal product (IMP) on participants with plaque psoriasis.
  • Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations, or is immunocompromised (e.g., human immunodeficiency virus, hepatitis B, and hepatitis C).
  • Any systemic disease considered by the investigator to be uncontrolled and either immunocompromising the participants and/or placing the participant at undue risk of intercurrent diseases (including, but not limited to, renal failure, heart failure, liver disease, diabetes, and anaemia).
  • History of Crohn's disease.
  • Myocardial infarction or stroke, or unstable angina pectoris within the past 12 months.
  • Any active malignancy.
  • History of malignancy within 5 years, except for treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma.
  • History of suicidal behaviour (i.e., 'actual suicide attempt', 'interrupted attempt', 'aborted attempt', or 'preparatory acts or behaviour') based on the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at screening or at baseline.
  • Any suicidal ideation of category 4 or 5 ('active suicidal ideation with some intent to act, without specific plan' or ' active suicidal ideation with specific plan and intent') based on the C-SSRS questionnaire at screening or at baseline.
  • A Patient Health Questionnaire (PHQ)-8 score of ≥10 corresponding to moderate-to-severe depression at screening or at baseline.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Brodalumab 210 mg + brodalumab 70 mg add-on* (adjusted brodalumab dosing regimen)
Participants will receive 210 mg brodalumab subcutaneously at Week 0, Week 1, and Week 2, and then once every 2 weeks. *Participants not fulfilling a predefined response at any visit with efficacy assessments after Week 16 will receive a dose adjustment to 280 mg brodalumab every 2 weeks.
Biological: Brodalumab
Brodalumab is an anti-IL-17 receptor antibody, which blocks the inflammatory effects of IL-17 in the skin.
Placebo Comparator: Brodalumab 210 mg + placebo add-on* (standard brodalumab treatment)
Participants will receive 210 mg brodalumab subcutaneously at Week 0, Week 1, and Week 2, and then once every 2 weeks. *Participants not fulfilling a predefined response at any time visit with efficacy assessments Week 16 will receive a dose adjustment to 210 mg brodalumab + placebo every 2 weeks.
Biological: Brodalumab
Brodalumab is an anti-IL-17 receptor antibody, which blocks the inflammatory effects of IL-17 in the skin.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Having at least 90% lower Psoriasis Area and Severity Index (PASI) score relative to baseline (PASI 90 response) at Week 40.
Time Frame: Week 40
The PASI score is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator will assess the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, according to a severity scale. The investigator will also assess the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0-72, with higher values indicating a more severe and/or more extensive condition.
Week 40

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Having static Physician's Global Assessment (sPGA) score of 0 or 1 at Week 40
Time Frame: Week 40
The sPGA is an instrument used in clinical trials to rate the severity of the participant's global psoriasis and is based on a 6-point scale ranging from 0 (clear) to 5 (very severe).
Week 40
Having PASI 90 response at Week 52
Time Frame: Week 52
The PASI score is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator will assess the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, according to a severity scale. The investigator will also assess the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0-72, with higher values indicating a more severe and/or more extensive condition. PASI 90 is defined as at least 90% improvement in PASI relative to baseline.
Week 52
Having sPGA score of 0 or 1 at Week 52
Time Frame: Week 52
The sPGA is an instrument used in clinical trials to rate the severity of the participant's global psoriasis and is based on a 6-point scale ranging from 0 (clear) to 5 (very severe).
Week 52
Having sPGA of genitalia (sPGA-G) score of 0 or 1 at Week 40
Time Frame: Week 40
The sPGA-G score is based on a combination of erythema and the secondary features (plaque elevation and/or scale) and it is used to rate the severity of the participant's psoriasis of the genitalia on a 6-point scale ranging from 0 (clear) to 5 (very severe).
Week 40
Having sPGA-G score of 0 or 1 at Week 52
Time Frame: Week 52
The sPGA-G score is based on a combination of erythema and the secondary features (plaque elevation and/or scale) and it is used to rate the severity of the participant's psoriasis of the genitalia on a 6-point scale ranging from 0 (clear) to 5 (very severe).
Week 52
Having PASI 100 response at Week 40
Time Frame: Week 40
The PASI score is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator will assess the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, according to a severity scale. The investigator will also assess the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0-72, with higher values indicating a more severe and/or more extensive condition. PASI 100 is defined as 100% improvement in PASI relative to baseline.
Week 40
Having PASI 100 response at Week 52
Time Frame: Week 52
The PASI score is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator will assess the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, according to a severity scale. The investigator will also assess the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0-72, with higher values indicating a more severe and/or more extensive condition. PASI 100 is defined as 100% improvement in PASI relative to baseline.
Week 52
Change from baseline at Weeks 40 and 52 in PASI score
Time Frame: Week 40 and 52
The PASI score is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator will assess the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, according to a severity scale. The investigator will also assess the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0-72, with higher values indicating a more severe and/or more extensive condition.
Week 40 and 52
Change from baseline at Weeks 40 and 52 in affected body surface area (BSA)
Time Frame: Week 40 and 52
To assess the full BSA with psoriatic involvement, the investigator will use the surface area of the participant's hand (palm and fingers) as a reference measurement to determine the percentage of the body surface area that is affected by psoriasis. One hand is approximately equal to 1% total BSA.
Week 40 and 52
Having Dermatology Life Quality Index (DLQI) total score of 0 or 1 at Week 40
Time Frame: Week 40
The Dermatology Life Quality Index (DLQI) is a validated questionnaire with content specific to those with dermatology conditions. The DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their HQoL over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all ⁄not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HQoL.
Week 40
Having DLQI total score of 0 or 1 at Week 52
Time Frame: Week 52
The Dermatology Life Quality Index (DLQI) is a validated questionnaire with content specific to those with dermatology conditions. The DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their HQoL over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all ⁄not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HQoL.
Week 52
Change from baseline at Weeks 40 and 52 in DLQI total score
Time Frame: Week 40 and 52
The Dermatology Life Quality Index (DLQI) is a validated questionnaire with content specific to those with dermatology conditions. The DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their health-related quality of life (HrQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment (10). Each item is scored on a 4-point Likert scale (0 = 'not at all ⁄not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HrQoL.
Week 40 and 52
Number of Participants Experiencing Adverse Events (AEs) up to Week 58.
Time Frame: Week 58
Week 58
Having sPGA of genitalia (sPGA-G) score of 0 or 1 at both Week 40 and Week 52
Time Frame: Week 40 and 52
The sPGA-G score is based on a combination of erythema and the secondary features (plaque elevation and/or scale) and it is used to rate the severity of the participant's psoriasis of the genitalia on a 6-point scale ranging from 0 (clear) to 5 (very severe).
Week 40 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LEO Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Medical Expert, LEO Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LP0160-1329
  • 2017-004998-13 (EudraCT Number)
  • U1111-1282-4507 (Other Identifier: World Health Organization (WHO))
  • 2023-509668-11-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

IPD Sharing Time Frame

Data is available to request after results of the trial are available on leopharmatrials.com

IPD Sharing Access Criteria

De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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