Dose-ranging Study of Nemolizumab in Atopic Dermatitis

October 3, 2019 updated by: Galderma R&D

Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Dose-ranging Study to Assess the Efficacy and Safety of Nemolizumab in Moderate-to-severe Atopic Dermatitis Subjects With Severe Pruritus Receiving Topical Corticosteroids (TCS)

Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments.

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

The aim of the study is to assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving topical corticosteroids, who were not adequately controlled with topical treatments.

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.
226

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 2

Contacts and Locations

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

Study Locations

  • Australia
      • Benowa, Australia, 4217 QLD
        • Galderma Investigational Site
      • Kogarah, Australia, NSW 2217
        • Galderma Investigational Site
      • Melbourne, Australia, VIC3002
        • Galderma Investigational Site
      • Phillip, Australia, ACT2606
        • Galderma Investigational Site
  • Canada
      • Calgary, Canada, AB T3A 2N1
        • Galderma Investigational Site
      • Markham, Canada, ON L3P 1X2
        • Galderma Investigational Site
      • Oakville, Canada, ON L6J 7W5
        • Galderma Investigational Site
      • Ottawa, Canada, K1G 6C6
        • Galderma Investigational Site
      • Ottawa, Canada, ON K2G 6E2
        • Galderma Investigational Site
      • Peterborough, Canada, K9J
        • Galderma Investigational Site
      • Richmond Hill, Canada, ON L4C
        • Galderma Investigational Site
      • Sainte-Foy, Canada, QC G1V4X7
        • Galderma Investigational Site
      • Waterloo, Canada, ON N2J 1C4
        • Galderma Investigational Site
  • France
      • Bordeaux, France, 33075
        • Galderma Investigational Site
      • Lille, France, 59037
        • Galderma Investigational Site
      • Marseille, France, 13385
        • Galderma Investigational Site
      • Nice, France, 06202
        • Galderma Investigational Site
      • Paris, France, 75010
        • Galderma Investigational Site
      • Toulouse, France, 31059
        • Galderma Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • Galderma Investigational Site
      • Berlin, Germany, 10789
        • Galderma Investigational Site
      • Darmstadt, Germany, 64283
        • Galderma Investigational Site
      • Erlangen, Germany, 91054
        • Galderma Investigational Site
      • Frankfurt, Germany, 60590
        • Galderma Investigational Site
      • Hamburg, Germany, 20354
        • Galderma Investigational Site
      • Hannöver, Germany, 30625
        • Galderma Investigational Site
      • Heidelberg, Germany, 69120
        • Galderma Investigational Site
      • Langenau, Germany, 89129
        • Galderma Investigational Site
      • Mainz, Germany, 55131
        • Galderma Investigational Site
      • München, Germany, 80337
        • Galderma Investigational Site
      • Osnabrück, Germany, 49074
        • Galderma Investigational Site
      • Stuttgart, Germany, 70718
        • Galderma Investigational Site
  • Poland
      • Katowice, Poland, 40-123
        • Galderma Investigational Site
      • Katowice, Poland, 40-648
        • Galderma Investigational Site
      • Kraków, Poland, 31-024
        • Galderma Investigational Site
      • Lublin, Poland, 20-080
        • Galderma Investigational Site
      • Warsaw, Poland, 01-817
        • Galderma Investigational Site
      • Warsaw, Poland, 02-758
        • Galderma Investigational Site
      • Warsaw, Poland, 02-625
        • Galderma Investigational Site
      • Wrocław, Poland, 51-318
        • Galderma Investigational Site
      • Łódź, Poland, 90-436
        • Galderma Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Galderma Investigational Site
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Galderma Investigational Site
    • California
      • Beverly Hills, California, United States, 90212
        • Galderma Investigational Site
      • Fountain Valley, California, United States, 92708
        • Galderma Investigational Site
      • Fremont, California, United States, 94538
        • Galderma Investigational Site
      • Rolling Hills Estates, California, United States, 90274
        • Galderma Investigational Site
      • Santa Ana, California, United States, 92701
        • Galderma Investigational Site
      • Santa Monica, California, United States, 90404
        • Galderma Investigational Site
    • Florida
      • Miami, Florida, United States, 33135
        • Galderma Investigational Site
      • Tampa, Florida, United States, 33607
        • Galderma Investigational Site
      • Tampa, Florida, United States, 33624
        • Galderma Investigational Site
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Galderma Investigational Site
      • Sandy Springs, Georgia, United States, 30328
        • Galderma Investigational Site
    • Illinois
      • Darien, Illinois, United States, 60561
        • Galderma Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Galderma Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Galderma Investigational Site
    • Michigan
      • Farmington Hills, Michigan, United States, 78334
        • Galderma Investigational Site
    • New York
      • Forest Hills, New York, United States, 11375
        • Galderma Investigational Site
      • New York, New York, United States, 10075
        • Galderma Investigational Site
      • New York, New York, United States, 10025
        • Galderma Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • Galderma Investigational Site
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Galderma Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Galderma Investigational Site
      • San Antonio, Texas, United States, 78218
        • Galderma Investigational Site
      • Waco, Texas, United States, 76710
        • Galderma Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23220
        • Galderma 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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects ≥ 18 years (or legal age when higher)
  • Chronic AD, that has been present for at least 2 years before the visit
  • Eczema Area and Severity Index (EASI) score ≥12
  • Investigator Global Assessment (IGA) score ≥ 3
  • AD involvement ≥ 10% of Body Surface Area (BSA)
  • Severe pruritus on at least 3 of the last 7 days before the visit
  • Documented recent history (within 6 months before the visit) of inadequate response to topical medications

  • Female subjects must fulfill one of the criteria below:

    • Female subjects of non-childbearing potential
    • Female subjects of childbearing potential who agree to a true abstinence or to use an effective or highly effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration

Exclusion Criteria:

  • Body weight < 45 kg
  • subjects with a medical history of asthma requiring hospitalization in the last 12 months before screening visit and/or whose asthma has not been well-controlled during the last 3 months before the screening visit and/or Peak Expiratory Flow (PEF) <80% of the predicted value
  • Cutaneous bacterial or viral infection within 1 week before the screening visit or during the run-in period
  • Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit or during the run-in period
  • History of intolerance to low or mid potency TCS or for whom TCS is not advisable

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
  • 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: Group 1
Nemolizumab (low dose)
Drug: Nemolizumab
Injection every 4 weeks during 24 weeks (last injection at week 20)
EXPERIMENTAL: Group 2
Nemolizumab (medium dose)
Drug: Nemolizumab
Injection every 4 weeks during 24 weeks (last injection at week 20)
EXPERIMENTAL: Group 3
Nemolizumab (high dose)
Drug: Nemolizumab
Injection every 4 weeks during 24 weeks (last injection at week 20)
PLACEBO_COMPARATOR: Group 4
Nemolizumab placebo
Drug: Placebo
Injection every 4 weeks during 24 weeks (last injection at week 20)

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
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24
Time Frame: From Baseline to Week 24
EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
From Baseline to Week 24

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
Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24
Time Frame: Week 24
The 4-point pruritus categorical scale was provided in their local language for the participants to report the intensity of their pruritus. Overall itching was scored as 0 for absence of pruritus and 3 for severe pruritus (bothersome itching/scratching that disturbs sleep). Higher scores indicate worse outcome.
Week 24
Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24
Time Frame: From Week 1 to Week 24
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
From Week 1 to Week 24
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
Time Frame: Baseline, Week 24
SCORAD ranges from 0 to 103 and has three components: extent (body surface area [BSA]), signs, and symptoms of AD. The severity of the 6 signs of AD (erythema/darkening, edema/papulation, oozing/crusting, excoriation, lichenification/prurigo and dryness), was assessed, each on a scale ranging from 0 (none) to 3 (severe).The component of extent corresponded to the extent of BSA affected by atopic dermatitis.The BSA involvement of AD was assessed for each part of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]), and was reported as a percentage of all major body sections combined. Participants were also asked to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a Visual analog scale (VAS) from 0 to 10. Higher scores indicate worse outcome.
Baseline, Week 24
Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
Time Frame: Baseline, Week 24
SCORAD ranges from 0 to 103 and has three components: extent (body surface area [BSA]), signs, and symptoms of AD. The severity of the 6 signs of AD (erythema/darkening, edema/papulation, oozing/crusting, excoriation, lichenification/prurigo and dryness), was assessed, each on a scale ranging from 0 (none) to 3 (severe).The component of extent corresponded to the extent of BSA affected by atopic dermatitis.The BSA involvement of AD was assessed for each part of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]), and was reported as a percentage of all major body sections combined. Participants were also asked to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a Visual analog scale (VAS) from 0 to 10. Higher scores indicate worse outcome.
Baseline, Week 24
Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
Time Frame: Baseline, Week 24
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night?: On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome.
Baseline, Week 24
Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
Time Frame: Baseline, Week 24
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night?: On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome.
Baseline, Week 24
Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24
Time Frame: From Week 1 to Week 24
IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used to evaluate the global severity of AD. Higher scores indicate worse outcome.
From Week 1 to Week 24
Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
Time Frame: From Week 1 to Week 24
EASI is a composite score ranging from 0 to 72. The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
From Week 1 to Week 24
Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
Time Frame: From Week 1 to Week 24
EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
From Week 1 to Week 24
Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
Time Frame: From Week 1 to Week 24
EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
From Week 1 to Week 24
Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24
Time Frame: Week 1 to Week 24
IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used to evaluate the global severity of AD. Higher scores indicate worse outcome.
Week 1 to Week 24
Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24
Time Frame: From Baseline to Week 24
EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
From Baseline to Week 24
Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
Time Frame: At baseline and Week 24
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
At baseline and Week 24
Number of Participants With Adverse Events
Time Frame: From screening to Follow-up visit (Week 32)/Early termination visit
To evaluate the safety of nemolizumab in participants with moderate-to-severe AD
From screening to Follow-up visit (Week 32)/Early termination visit
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
Time Frame: Baseline to Week 24
Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
Baseline to Week 24
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
Time Frame: Baseline to Week 24
Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For average itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
Baseline to Week 24
Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
Time Frame: Baseline to Week 24
Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For average itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
Baseline to Week 24

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.
Galderma R&D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
June 14, 2017

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.
July 19, 2018

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.
September 21, 2018

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 29, 2017

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 29, 2017

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.
April 4, 2017

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.
October 22, 2019

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.
October 3, 2019

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.
October 1, 2019

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.
  • RD.03.SPR.114322

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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