A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid (BALLAD+)

April 7, 2024 updated by: argenx

An Open-label Extension Study of ARGX-113-2009 to Evaluate the Long Term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid

ARGX-113-2010 is an open-label extension study with the aim to provide supporting evidence that efgartigimod PH20 SC is a safe and effective long-term treatment for bullous pemphigoid (BP), providing symptom control and eventually remission, while also reducing the cumulative exposure to oral corticosteroids (OCS).

All participants who complete the end-of-treatment period (EoTP) visit at week 36 in ARGX-113-2009 will be invited to enroll.

In ARGX-113-2009, participants received efgartigimod PH20 SC or placebo with concurrent OCS, or rescue therapy (without efgartigimod PH20 SC or placebo). Depending on their clinical status at the time of rollover into ARGX-113-2010, participants may stop, continue or initiate efgartigimod PH20 SC treatment. In ARGX-113-2010, participants will stop efgartigimod PH20 SC treatment when they achieve complete remission (CR) or partial remission (PR) while being off other concurrent BP therapy for at least 8 weeks. Participants not in CR or PR while off OCS for ≥8 weeks and not on rescue therapy will either start or continue efgartigimod PH20 SC treatment, while maintaining the treatment allocation of ARGX-113-2009 blinded. Participants may also be retreated with efgartigimod PH20 SC after a relapse. In this study, loading doses of 2000 mg (on day 1 and day 8 of a treatment course) and weekly maintenance doses of 1000 mg will be used.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 3

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 Locations

  • Australia
      • Kogarah, Australia, 2217
  • Bulgaria
      • Sofia, Bulgaria, 1431
        • Recruiting
        • Diagnostic and Consulting Center Aleksandrovska EOOD
        • Contact:
  • China
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
  • Croatia
      • Zagreb, Croatia, 10000
  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • Charité - Universitätsmedizin Berlin
        • Contact:
      • Dresden, Germany, 01307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus an der TU Dresden
        • Contact:
      • Düsseldorf, Germany, 40225
        • Recruiting
        • Universitätsklinikum Düsseldorf
        • Contact:
          • Stephan Meller, MD
      • Kiel, Germany, 24105
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein
        • Contact:
      • München, Germany, 80337
        • Recruiting
        • LMU Klinikum der Universität
        • Contact:
  • Greece
      • Athens, Greece, 16121
        • Recruiting
        • Hospital of Venereal and Skin Diseases A.Syggros
        • Contact:
  • Hungary
      • Budapest, Hungary, 1085
  • Israel
      • Ramat Gan, Israel, 5262100
        • Recruiting
        • Sheba Medical Center - PPDS
        • Contact:
  • Italy
      • Catania, Italy, 95123
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
        • Contact:
          • Giuseppe Micali, MD
      • Firenze, Italy, 50125
        • Not yet recruiting
        • Azienda Sanitaria Di Firenze
        • Contact:
      • Firenze, Italy, 50122
        • Recruiting
        • Azienda USL Toscana Centro - Ospidale Piero Palagi
        • Contact:
      • Genova, Italy, 16132
        • Recruiting
        • Ospedale Policlinico San Martino
        • Contact:
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo di Pavia
        • Contact:
      • Rome, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A. Gemelli
        • Contact:
          • Clara De Simone, MD
  • Japan
      • Sapporo, Japan, 060-8648
        • Not yet recruiting
        • Hokkaido University Hospital
        • Contact:
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • Universitair Medisch Centrum Groningen
        • Contact:
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • University Clinical Center of Serbia - PPDS
        • Contact:
  • Slovakia
      • Trnava, Slovakia, 91702
        • Recruiting
        • Fakultna nemocnica Trnava
        • Contact:
          • Peter Kozub, MD
  • Spain
      • Granada, Spain, 18016
        • Recruiting
        • Hospital Universitario Clinico San Cecilio
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Valencia, Spain, 46017
        • Recruiting
        • Hospital Universitario Doctor Peset
        • Contact:
          • Andrea Estebanez Corrales, MD
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust
        • Contact:
  • United States
    • California
      • Fountain Valley, California, United States, 92708
    • Florida
      • Miami, Florida, United States, 33173
        • Not yet recruiting
        • Miami Dermatology and Laser Institute
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Hospital
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63110

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has completed the week 36 visit of ARGX-113-2009
  • Is capable of providing signed informed consent and complying with protocol requirements
  • Agrees to use contraceptive measures consistent with local regulations and the following: Women of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP and must use one of the contraception methods described in the protocol from signing the ICF until the last dose of IMP

Exclusion Criteria:

  • Clinically significant disease, recent major surgery (within 3 months of baseline), or intends to have surgery during the study; or any other medical condition that, in the investigator's opinion would confound the results of the study or put the participant at undue risk
  • Known hypersensitivity to IMP or 1 of its excipients
  • Permanently discontinued IMP in ARGX-113-2009 due to an AE considered related to IMP and for whom the benefit/risk balance is not considered positive

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: efgartigimod PH20 SC
participants receiving efgartigimod PH20 SC on top of Prednisone
Biological: efgartigimod PH20 SC
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
Drug: Prednisone
Oral Prednisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events
Time Frame: Up to 56 weeks
Incidence of treatment-emergent adverse events
Up to 56 weeks
Severity of treatment-emergent adverse events
Time Frame: Up to 56 weeks
Severity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events ( CTCAE) definitions (current version): Grade 1 (mild) to Grade 5 (death related to adverse event)
Up to 56 weeks
Incidence of serious adverse events
Time Frame: Up to 56 weeks
Incidence of serious adverse events
Up to 56 weeks
Severity of serious adverse events
Time Frame: Up to 56 weeks
Severity of serious adverse events
Up to 56 weeks
Incidence of adverse events of special interest
Time Frame: Up to 56 weeks
Incidence of adverse events of special interest
Up to 56 weeks
Severity of adverse events of special interest
Time Frame: Up to 56 weeks
Severity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events ( CTCAE) definitions (current version): Grade 1 (mild) to Grade 5 (death related to adverse event)
Up to 56 weeks
Rate of treatment discontinuation because of safety concerns
Time Frame: Up to 56 weeks
Rate of treatment discontinuation because of safety concerns
Up to 56 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving complete remission while off oral corticosteroids for ≥ 8 weeks
Time Frame: Up to 56 weeks
Proportion of participants achieving complete remission while off oral corticosteroids for ≥ 8 weeks
Up to 56 weeks
Proportion of participants achieving complete remission or partial remission while off oral corticosteroids for ≥ 8 weeks
Time Frame: Up to 56 weeks
Proportion of participants achieving complete remission or partial remission while off oral corticosteroids for ≥ 8 weeks
Up to 56 weeks
Proportion of participants achieving complete remission while on minimal oral corticosteroids therapy for ≥ 8 weeks
Time Frame: Up to 56 weeks
Minimal oral corticosteroid therapy is defined as ≤0.10 mg/kg/day of prednisone (or an equivalent dose of another oral corticosteroid)
Up to 56 weeks
Proportion of participants achieving complete remission while off both oral corticosteroids and efgartigimod PH20 SC for ≥ 8 weeks
Time Frame: Up to 56 weeks
Proportion of participants achieving complete remission while off both oral corticosteroids and efgartigimod PH20 SC for ≥ 8 weeks
Up to 56 weeks
Proportion of participants achieving complete remission or partial remission while off both oral corticosteroids and efgartigimod PH20 SC for ≥ 8 weeks
Time Frame: Up to 56 weeks
Proportion of participants achieving complete remission or partial remission while off both oral corticosteroids and efgartigimod PH20 SC for ≥ 8 weeks
Up to 56 weeks
Duration of sustained remission
Time Frame: Up to 56 weeks
Duration of sustained remission
Up to 56 weeks
Proportion of participants who relapse
Time Frame: Up to 56 weeks
Proportion of participants who relapse
Up to 56 weeks
Time to relapse
Time Frame: Up to 56 weeks
Time to relapse
Up to 56 weeks
Incidence of relapse
Time Frame: Up to 56 weeks
Incidence of relapse
Up to 56 weeks
Severity of relapse
Time Frame: Up to 56 weeks
Severity of relapse will be assessed based on the Bullous Pemphigoid Disease Area Index (BPDAI)
Up to 56 weeks
Bullous Pemphigoid Disease Area Index (BPDAI) activity scores over time
Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 2, 4, 8, 16, 24, 32, 40, 48 and 56.
Bullous Pemphigoid Disease Area Index (BPDAI) activity scores over time
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 2, 4, 8, 16, 24, 32, 40, 48 and 56.
Bullous Pemphigoid Disease Area Index (BPDAI) activity scores over time
Time Frame: For participants continuing/starting efgartigimod PH20 SC treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 4 weeks until efgartigimod stop, every 8 weeks after efgartigimod stop and at weeks 48, 52 and 56.
Bullous Pemphigoid Disease Area Index (BPDAI) activity scores over time
For participants continuing/starting efgartigimod PH20 SC treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 4 weeks until efgartigimod stop, every 8 weeks after efgartigimod stop and at weeks 48, 52 and 56.
Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) scores over time
Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 2, 4, 8, 16, 24, 32, 40, 48 and 56.
Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) scores over time
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 2, 4, 8, 16, 24, 32, 40, 48 and 56.
Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) scores over time
Time Frame: For participants continuing/starting efgartigimod PH20 SC treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 4 weeks until efgartigimod stop, every 8 weeks after efgartigimod stop and at weeks 48, 52 and 56.
Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) scores over time
For participants continuing/starting efgartigimod PH20 SC treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 4 weeks until efgartigimod stop, every 8 weeks after efgartigimod stop and at weeks 48, 52 and 56.
Itch Numerical Rating Scale (NRS) over time
Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 2, 4, 8, 16, 24, 32, 40, 48 and 56.
Itch Numerical Rating Scale (NRS) over time
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 2, 4, 8, 16, 24, 32, 40, 48 and 56.
Itch Numerical Rating Scale (NRS) over time
Time Frame: For participants continuing/starting efgartigimod PH20 SC treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 4 weeks until efgartigimod stop, every 8 weeks after efgartigimod stop and at weeks 48, 52 and 56.
Itch Numerical Rating Scale (NRS) over time
For participants continuing/starting efgartigimod PH20 SC treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 4 weeks until efgartigimod stop, every 8 weeks after efgartigimod stop and at weeks 48, 52 and 56.
Rate of treatment failure
Time Frame: Up to 56 weeks
Rate of treatment failure
Up to 56 weeks
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index - Aggregate Improvement Score (GTI-AIS) over time
Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48.
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index - Aggregate Improvement Score (GTI-AIS) over time
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48.
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index - Aggregate Improvement Score (GTI-AIS) over time
Time Frame: For participants continuing/starting efgartigimod treatment at rollover or relapse: weeks 0, 8, every 16 weeks until and after efgartigimod treatment stop and at week 48.
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index - Aggregate Improvement Score (GTI-AIS) over time
For participants continuing/starting efgartigimod treatment at rollover or relapse: weeks 0, 8, every 16 weeks until and after efgartigimod treatment stop and at week 48.
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Cumulative Worsening Score (GTI-CWS) over time
Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48.
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Cumulative Worsening Score (GTI-CWS) over time
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48.
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Cumulative Worsening Score (GTI-CWS) over time
Time Frame: For participants continuing/starting efgartigimod treatment at rollover or relapse: weeks 0, 8, every 16 weeks until and after efgartigimod treatment stop and at week 48.
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Cumulative Worsening Score (GTI-CWS) over time
For participants continuing/starting efgartigimod treatment at rollover or relapse: weeks 0, 8, every 16 weeks until and after efgartigimod treatment stop and at week 48.
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Specific List (GTI-SL) over time
Time Frame: For participants not requiring treatment with efgartigimod at rollover: at weeks 0, 24 and 48.
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Specific List (GTI-SL) over time
For participants not requiring treatment with efgartigimod at rollover: at weeks 0, 24 and 48.
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Specific List (GTI-SL) over time
Time Frame: For participants continuing/starting efgartigimod treatment at rollover or relapse: weeks 0, 8, every 16 weeks until and after efgartigimod treatment stop and at week 48.
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Specific List (GTI-SL) over time
For participants continuing/starting efgartigimod treatment at rollover or relapse: weeks 0, 8, every 16 weeks until and after efgartigimod treatment stop and at week 48.
EQ-5D-5L scores over time
Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48.
EQ-5D-5L scores over time
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48.
EQ-5D-5L scores over time
Time Frame: For participants continuing/starting efgartigimod treatment at rollover or relapse: at weeks 0, 8, every 16 weeks until and after efgartigimod PH20 SC treatment stop and at week 48.
EQ-5D-5L scores over time
For participants continuing/starting efgartigimod treatment at rollover or relapse: at weeks 0, 8, every 16 weeks until and after efgartigimod PH20 SC treatment stop and at week 48.
Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time
Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48.
Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48.
Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time
Time Frame: For participants continuing/starting efgartigimod treatment at rollover or relapse: at weeks 0, 8, every 16 weeks until and after efgartigimod PH20 SC treatment stop and at week 48.
Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time
For participants continuing/starting efgartigimod treatment at rollover or relapse: at weeks 0, 8, every 16 weeks until and after efgartigimod PH20 SC treatment stop and at week 48.
Dermatology Life Quality Index (DLQI) scores over time
Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48.
Dermatology Life Quality Index (DLQI) scores over time
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48.
Dermatology Life Quality Index (DLQI) scores over time
Time Frame: For participants continuing/starting efgartigimod treatment at rollover or relapse: at weeks 0, 8, every 16 weeks until and after efgartigimod PH20 SC treatment stop and at week 48.
Dermatology Life Quality Index (DLQI) scores over time
For participants continuing/starting efgartigimod treatment at rollover or relapse: at weeks 0, 8, every 16 weeks until and after efgartigimod PH20 SC treatment stop and at week 48.
Percent changes from baseline over time for anti-BP180 and anti-BP-230 antibody levels
Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 2, 4, 8, 16, 24, 32, 40, 48 and 56.
Percent changes from baseline over time for anti-BP180 and anti-BP-230 antibody levels
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 2, 4, 8, 16, 24, 32, 40, 48 and 56.
Percent changes from baseline over time for anti-BP180 and anti-BP-230 antibody levels
Time Frame: For participants continuing/starting efgartigimod PH20 SC treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 4 weeks to efgartigimod stop, every 8 weeks after efgartigimod stop and at weeks 48, 52 and 56.
Percent changes from baseline over time for anti-BP180 and anti-BP-230 antibody levels
For participants continuing/starting efgartigimod PH20 SC treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 4 weeks to efgartigimod stop, every 8 weeks after efgartigimod stop and at weeks 48, 52 and 56.
Incidence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 4, 8, 16, 24, 32, 40, 48 and 56.
Incidence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 4, 8, 16, 24, 32, 40, 48 and 56.
Incidence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
Time Frame: For participants continuing/starting efgartigimod treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 8 weeks until and after efgartigimod PH20 SC stop and at weeks 48, 52 and 56.
Incidence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
For participants continuing/starting efgartigimod treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 8 weeks until and after efgartigimod PH20 SC stop and at weeks 48, 52 and 56.
Prevalence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 4, 8, 16, 24, 32, 40, 48 and 56.
Prevalence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 4, 8, 16, 24, 32, 40, 48 and 56.
Prevalence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
Time Frame: For participants continuing/starting efgartigimod treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 8 weeks until and after efgartigimod PH20 SC stop and at weeks 48, 52 and 56.
Prevalence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
For participants continuing/starting efgartigimod treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 8 weeks until and after efgartigimod PH20 SC stop and at weeks 48, 52 and 56.

Collaborators and Investigators

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

Sponsor

argenx

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)

March 22, 2023

Primary Completion (Estimated)

January 9, 2026

Study Completion (Estimated)

March 6, 2026

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

December 27, 2022

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARGX-113-2010

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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