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Study of Daxdilimab (HZN-7734) in Patients With Moderate-to-Severe Primary Discoid Lupus Erythematosus

Primary Purpose

Discoid Lupus Erythematosus

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo/Daxdilimab
Daxdilimab
Daxdilimab
Sponsored by
Horizon Therapeutics Ireland DAC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Discoid Lupus Erythematosus focused on measuring Discoid Lupus Erythematosus, Immune System Diseases, Lupus Erythematosus, Cutaneous, Skin Diseases, Connective Tissue Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Willing and able to understand and provide written informed consent.
  • Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
  • A diagnosis of discoid lupus erythematosus for ≥ 6 months prior to screening supported by a history of:

    1. A biopsy and/or
    2. a clinical feature score of ≥ 7 on the DLE Classification Criteria (DLECC) scale
  • Currently active discoid lupus with all the following

    1. Digital photography adjudicated with central reading to confirm a currently active discoid disease lesion.
    2. CLASI-A score ≥ 8 related to discoid lesions at Baseline
  • Treatment refractory DLE
  • Women of childbearing potential must have a negative urine pregnancy test on Day 1.
  • Nonsterilized male subjects who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Day 1 and until 3 months (approximately 5 half-lives) after receipt of the last dose.

Key Exclusion Criteria:

  • Participation in another clinical study with an investigational drug within 4 weeks prior to Randomization or within 5 published half-lives, whichever is longer.
  • Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product (IP) or interpretation of participant safety or trial results.
  • Weight > 160 kg (352 pounds) at Screening.
  • History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or to a previous monoclonal antibody (mAb) or human immunoglobin (Ig) therapy.
  • Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the informed consent form (ICF) through 6 months after receiving the last dose of IP.
  • Splenectomy
  • Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to Screening through Randomization.
  • History of clinically significant cardiac disease including unstable angina, myocardial infarction, congestive heart failure within 6 months prior to Randomization; arrhythmia requiring active therapy, except for clinically insignificant extra systoles, or minor conduction abnormalities.
  • History of cancer within the past 5 years, except as follows:

    • In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to Screening, or
    • Cutaneous basal cell or squamous cell carcinoma treated with curative therapy.
  • Any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection.
  • Known history of a primary immunodeficiency or an underlying condition, such as known human immunodeficiency virus (HIV) infection, or a positive result for HIV infection per central laboratory.
  • Confirmed positive test for hepatitis B virus serology defined as:

    • Hepatitis B surface antigen, or
    • Hepatitis B core antibody
  • Positive test for hepatitis C virus antibody unless documented as having had successful treatment of active hepatitis C infection.
  • Active tuberculosis (TB), or a positive interferon-gamma release assay (IGRA) test at Screening, unless documented history of appropriate treatment for active or latent TB. Participants with an indeterminate IGRA test result can repeat the test, but if the repeat test is also indeterminate, they will be excluded.
  • Any severe herpes virus family infection (including Epstein-Barr virus, cytomegalovirus (CMV)) at any time prior to Randomization, including, but not limited to, disseminated herpes, herpes encephalitis, recent recurrent herpes zoster (defined as 2 episodes within the last 2 years), or ophthalmic herpes.
  • Any herpes zoster, cytomegalovirus (CMV), or Epstein-Barr virus infection that was not completely resolved 12 weeks prior to Randomization.
  • Opportunistic infection requiring hospitalization or parenteral antimicrobial treatment within 2 years prior to Randomization.
  • Any acute illness or evidence of clinically significant active infection on Day 1.
  • Participants who have COVID-19 or other significant infection, or in the judgment of the Investigator, may be at a high risk of COVID-19 or its complications should not be randomized.
  • Systemic lupus erythematosus defined by fulfilling 2020 American College of Rheumatology/European Alliance of Associations for Rheumatology criteria for systemic lupus erythematosus (SLE).
  • Current diagnosis of a systemic connective tissue disease.
  • Current inflammatory skin disease other than DLE, that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments and confound the disease activity assessments.
  • Exposure to an experimental drug either 30 days, 5 half-lives of the agent, or twice the duration of the biological effect of the agent, whichever is longer, prior to Randomization and through the final trial visit.
  • Receipt of a live-attenuated vaccine within 4 weeks prior to Randomization.

Sites / Locations

  • Arkansas Research TrialsRecruiting
  • Wallace Medical GroupRecruiting
  • The Center for Dermatology Clinical ResearchRecruiting
  • Clinical Science InstituteRecruiting
  • Miami Dermatology & Laser ResearchRecruiting
  • Dawes Fretzin Clinical Research Group, LLCRecruiting
  • Detroit Clinical Research Center, PC
  • Michigan Dermatology InstituteRecruiting
  • Minnesota Clinical Study CenterRecruiting
  • MediSearch Clinical TrialsRecruiting
  • Forest Hills DermatologyRecruiting
  • Ohio State UniversityRecruiting
  • Wright State PhysiciansRecruiting
  • Paddington Testing Company, Inc.Recruiting
  • Autoimmune Skin Diseases Unit, Dept. of DermatologyRecruiting
  • Center for Clinical Studies (Cypress)Recruiting
  • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/ARecruiting
  • Hospital Moinhos de VentoRecruiting
  • LMK Serviços Médicos S/SRecruiting
  • Hospital Christovão da Gama - Centro de EstudosRecruiting
  • Centro Multidisciplinar de Estudos ClinicosRecruiting
  • IMC - Instituto de Moléstias Cardiovasculares TatuíRecruiting
  • DCC 'Sveti Georgi' EOODRecruiting
  • Ambulatory for specialized medical care - individual practice for specialized medical care - skin and venereal diseasesRecruiting
  • DCC "Alexandrovska" EOODRecruiting
  • Medical Center Eurohealth EOODRecruiting
  • Alberta DermaSurgery CentreRecruiting
  • Brunswick Dermatology CenterRecruiting
  • DermEffectsRecruiting
  • North York Research, IncRecruiting
  • K. Papp Clinical Research
  • Sanatorium Profesora ArenbergeraRecruiting
  • Bispebjerg Hospital, Dermato-Venerologisk Afdeling Og Videncenter for Sårheling, D/S.Recruiting
  • OUHRecruiting
  • Sjællands UniversitetshospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo/Daxdilimab Arm 1

Daxdilimab Arm 2

Daxdilimab Arm 3

Arm Description

Administration of placebo Q4W from Day 1 through Week 20 and administration of Daxdilimab Q4W from Week 24 through Week 44.

Administration of Daxdilimab Q4W from Day 1 through Week 44.

Administration of Daxdilimab Q4W from Day 1 through Week 44.

Outcomes

Primary Outcome Measures

Mean change in Cutaneous Lupus Erythematosus Disease and Severity Index-Activity (CLASI-A) score from Baseline to Week 24.

Secondary Outcome Measures

Proportion of participants who achieve 0 or 1 on the Cutaneous Lupus Activity-Investigator's Global Assessment (CLA-IGA) scale at Week 24 (5-point Likert scale [0-4]).
Proportion of participants who achieve a ≥ 50% reduction in Cutaneous Lupus Erythematosus Disease and Severity Index-Activity (CLASI-A) score from Baseline (Day 1) at Week 24.
Mean change in the Score of Activity and Damage in Discoid Lupus Erythematosus (SADDLE) from Baseline (Day 1) to Week 24 patients with primary DLE.
Serum concentration of daxdilimab over time.
Anti-Drug Antibody (ADA) rate.
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and treatment-emergent adverse events of special interest (TEAESIs).

Full Information

First Posted
October 19, 2022
Last Updated
October 3, 2023
Sponsor
Horizon Therapeutics Ireland DAC
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1. Study Identification

Unique Protocol Identification Number
NCT05591222
Brief Title
Study of Daxdilimab (HZN-7734) in Patients With Moderate-to-Severe Primary Discoid Lupus Erythematosus
Official Title
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Investigate the Efficacy and Safety of Daxdilimab Subcutaneous Injection in Reducing Disease Activity in Adult Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Horizon Therapeutics Ireland DAC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Phase 2, double-blind, randomized, placebo-controlled parallel-group study to evaluate the efficacy and safety of daxdilimab in participants with moderate-to-severe active primary Discoid Lupus Erythematosus (DLE) refractory to standard of care.
Detailed Description
Approximately 99 participants will be enrolled to receive daxdilimab or placebo administered subcutaneously once every four weeks (Q4W) from Day 1 to Week 44. After week 24 all subjects will be receiving daxbilimab, including those assigned to the placebo arm, Q4W from Week 24 to Week 44. The maximum trial duration per participant is approximately 60 weeks including screening, the 48 weeks for the treatment period where participants will receive daxdilimab or placebo, and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discoid Lupus Erythematosus
Keywords
Discoid Lupus Erythematosus, Immune System Diseases, Lupus Erythematosus, Cutaneous, Skin Diseases, Connective Tissue Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo/Daxdilimab Arm 1
Arm Type
Placebo Comparator
Arm Description
Administration of placebo Q4W from Day 1 through Week 20 and administration of Daxdilimab Q4W from Week 24 through Week 44.
Arm Title
Daxdilimab Arm 2
Arm Type
Experimental
Arm Description
Administration of Daxdilimab Q4W from Day 1 through Week 44.
Arm Title
Daxdilimab Arm 3
Arm Type
Experimental
Arm Description
Administration of Daxdilimab Q4W from Day 1 through Week 44.
Intervention Type
Drug
Intervention Name(s)
Placebo/Daxdilimab
Intervention Description
Placebo/Daxdilimab will be administered subcutaneously as two injections for each dose.
Intervention Type
Drug
Intervention Name(s)
Daxdilimab
Other Intervention Name(s)
HZN-7734
Intervention Description
Daxdilimab will be administered subcutaneously as two injections for each dose.
Intervention Type
Drug
Intervention Name(s)
Daxdilimab
Other Intervention Name(s)
HZN-7734
Intervention Description
Daxdilimab will be administered subcutaneously as two injections for each dose.
Primary Outcome Measure Information:
Title
Mean change in Cutaneous Lupus Erythematosus Disease and Severity Index-Activity (CLASI-A) score from Baseline to Week 24.
Time Frame
Day 1 to Week 24
Secondary Outcome Measure Information:
Title
Proportion of participants who achieve 0 or 1 on the Cutaneous Lupus Activity-Investigator's Global Assessment (CLA-IGA) scale at Week 24 (5-point Likert scale [0-4]).
Time Frame
Day 1 to Week 24
Title
Proportion of participants who achieve a ≥ 50% reduction in Cutaneous Lupus Erythematosus Disease and Severity Index-Activity (CLASI-A) score from Baseline (Day 1) at Week 24.
Time Frame
Day 1 to Week 24
Title
Mean change in the Score of Activity and Damage in Discoid Lupus Erythematosus (SADDLE) from Baseline (Day 1) to Week 24 patients with primary DLE.
Time Frame
Day 1 to Week 24
Title
Serum concentration of daxdilimab over time.
Time Frame
Day 1 to Week 48
Title
Anti-Drug Antibody (ADA) rate.
Time Frame
Day 1 to Week 56
Title
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and treatment-emergent adverse events of special interest (TEAESIs).
Time Frame
Day 1 to Week 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Willing and able to understand and provide written informed consent. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial. A diagnosis of discoid lupus erythematosus for ≥ 6 months prior to screening supported by a history of: A biopsy or a clinical feature score of ≥ 7 on the DLE Classification Criteria (DLECC) scale Currently active discoid lupus with all the following Digital photography adjudicated with central reading to confirm a currently active discoid disease lesion. CLASI-A score ≥ 8 related to discoid lesions at Baseline Treatment refractory DLE defined as active disease despite current or historical treatment with a systemic treatment. Females are eligible to participate if they are not pregnant or breastfeeding, and meet the contraceptive/barrier requirement(s). Males are eligible to participate if they agree to the contraceptive/barrier requirement(s). Vaccination status should be up to date per local standards. Key Exclusion Criteria: Participation in another clinical study with an investigational drug within 4 weeks prior to Randomization or within 5 published half-lives, whichever is longer. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product (IP) or interpretation of participant safety or trial results. Weight > 160 kg (352 pounds) at Screening. History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or to a previous monoclonal antibody (mAb) or human immunoglobin (Ig) therapy. Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the informed consent form (ICF) through 6 months after receiving the last dose of IP. Splenectomy Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to screening through randomization. History of clinically significant cardiac disease including unstable angina, myocardial infarction, congestive heart failure within 6 months prior to Randomization; arrhythmia requiring active therapy, except for clinically insignificant extra systoles, or minor conduction abnormalities. History of cancer within the past 5 years, except as follows: In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to Screening, or Cutaneous basal cell or squamous cell carcinoma treated with curative therapy. Any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection. Known history of a primary immunodeficiency or an underlying condition, such as known human immunodeficiency virus (HIV) infection, or a positive result for HIV infection per central laboratory. Participants with positive hepatitis B serologic test results. All participants will undergo testing for hepatitis C antibody (HCVAb) during Screening. Participants who are HCVAb positive will be reflex tested for hepatitis C virus (HCV) RNA and if HCV RNA is positive, the participant is not eligible for the study. Active tuberculosis (TB), or a positive interferon-gamma release assay (IGRA) test at screening, unless documented history of appropriate treatment for active or latent TB. Participants with an indeterminate IGRA test result can repeat the test, but if the repeat test is also indeterminate, they will be excluded. Any severe herpes virus family infection (including Epstein-Barr virus, cytomegalovirus (CMV)) at any time prior to Randomization, including, but not limited to, disseminated herpes, herpes encephalitis, recent recurrent herpes zoster (defined as 2 episodes within the last 2 years), or ophthalmic herpes. Any herpes zoster, cytomegalovirus (CMV), or Epstein-Barr virus infection that was not completely resolved 12 weeks prior to Randomization. Opportunistic infection requiring hospitalization or parenteral antimicrobial treatment within 2 years prior to Randomization. Any acute illness or evidence of clinically significant active infection on Day 1. Participants who have COVID-19 or other significant infection, or in the judgment of the Investigator, may be at a high risk of COVID-19 or its complications should not be randomized. Systemic lupus erythematosus defined by fulfilling 2020 American College of Rheumatology/European Alliance of Associations for Rheumatology criteria for systemic lupus erythematosus (SLE). Current diagnosis of a systemic connective tissue disease. Current inflammatory skin disease other than DLE, that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments and confound the disease activity assessments. Exposure to an experimental drug either 30 days, 5 half-lives of the agent, or twice the duration of the biological effect of the agent, whichever is longer, prior to Randomization and through the final trial visit. Receipt of a live-attenuated vaccine within 4 weeks prior to Randomization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Horizon Therapeutics
Phone
1-866-479-6742
Email
clinicaltrials@horizontherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Horizon Therapeutics Ireland DAC
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Research Trials
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jimmy Tutton
Phone
501-621-1100
Email
jtutton@arkansasresearchtrials.com
First Name & Middle Initial & Last Name & Degree
Scott Dinehart, MD
Facility Name
Wallace Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackie Bral
Phone
310-777-0405
Email
jmorenobral@sbcglobal.net
First Name & Middle Initial & Last Name & Degree
Paul Wallace, MD
Facility Name
The Center for Dermatology Clinical Research
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cindy Epps
Email
cindye@ctr4derm.com
First Name & Middle Initial & Last Name & Degree
Sunil Dhawan, MD
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Ferguson
Phone
310-828-8887
Email
cferguson@csird.com
First Name & Middle Initial & Last Name & Degree
Paul Yamauchi, MD
Facility Name
Miami Dermatology & Laser Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moreno Stephany
Phone
305-279-6060
Email
stephanym@miamidermlaser.com
First Name & Middle Initial & Last Name & Degree
Jill Waibel, MD
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Wallace
Phone
317-516-5030
Email
Awallace@ecommunity.com
First Name & Middle Initial & Last Name & Degree
Scott Fretzin, MD
Facility Name
Detroit Clinical Research Center, PC
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rameez Umer
Email
rameez.umer@dcrc.us
First Name & Middle Initial & Last Name & Degree
Niculina Lupu
Email
niculina.lupu@dcrc.us
First Name & Middle Initial & Last Name & Degree
Wendy Sadoff, MD
Facility Name
Michigan Dermatology Institute
City
Waterford
State/Province
Michigan
ZIP/Postal Code
48328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raven Ashley
Phone
248-681-9541
Email
raven.ashley@michigandermatologyinstitute.com
First Name & Middle Initial & Last Name & Degree
Cory Rubin, MD
Facility Name
Minnesota Clinical Study Center
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Buffi Elliott
Phone
763-571-4200
Email
belliott@associatedskincare.com
First Name & Middle Initial & Last Name & Degree
Steven Kempers, MD
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clarissa Murphy
Phone
816-364-1515
Email
Clarissa.murphy@medisearchderma.com
First Name & Middle Initial & Last Name & Degree
Melody Stone, MD
Facility Name
Forest Hills Dermatology
City
Forest Hills
State/Province
New York
ZIP/Postal Code
11375
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tazrin Tripti
Phone
718-459-0900
Email
mtripti@aol.com
First Name & Middle Initial & Last Name & Degree
Jeffery Weinberg, MD
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Cooper
Phone
614-293-9306
Email
rachel.cooper@osumc.edu
First Name & Middle Initial & Last Name & Degree
Abraham Korman, MD
Facility Name
Wright State Physicians
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Hong
Phone
937-245-7500
Email
jessica.hong@wspi.org
First Name & Middle Initial & Last Name & Degree
Jeffrey Travers, MD
Facility Name
Paddington Testing Company, Inc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Champac Routh
Phone
215-563-7330
Email
routhchampak2@gmail.com
First Name & Middle Initial & Last Name & Degree
Jennifer Parish, MD
Facility Name
Autoimmune Skin Diseases Unit, Dept. of Dermatology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joy Poroye
Phone
215-615-2940
Email
poroyej@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Victoria Werth, MD
Facility Name
Center for Clinical Studies (Cypress)
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lilia Garcia
Phone
281-377-6665
Email
lgarcia@studiesindermatology.com
First Name & Middle Initial & Last Name & Degree
Lauren Campbell, MD
Facility Name
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
City
Rio de Janeiro
State/Province
Rio Do Janeiro
ZIP/Postal Code
20241-180
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monik Pizzini
Phone
+55 21 25277979
Email
monik.pizzini@ibpclin.com
First Name & Middle Initial & Last Name & Degree
Jaqueline Barbeito de Vasconcellos
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lidia Farias
Phone
+55 (51) 3314 3109
Email
lidia.martins@hmv.org.br
First Name & Middle Initial & Last Name & Degree
Andre' Vicente Esteves de Carval
Facility Name
LMK Serviços Médicos S/S
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90480-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Desirèe Porto dos Santos Vargas
Phone
+5551 30613440
Email
mk.reumatodesiree@gmail.com
First Name & Middle Initial & Last Name & Degree
Paula Berenhauser D Elia
Facility Name
Hospital Christovão da Gama - Centro de Estudos
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09030-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santos Isabel
Phone
+55 (11) 99178-737
Email
isabel.santos@svriglobal.com
First Name & Middle Initial & Last Name & Degree
Andréia Castanheiro da Costa
Facility Name
Centro Multidisciplinar de Estudos Clinicos
City
São Bernardo Do Campo
State/Province
Sao Paulo
ZIP/Postal Code
09715
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Olieira
Phone
+55 (11)4930 4243
Email
ingrid.oliveira@cemecpesquisaclinica.com
First Name & Middle Initial & Last Name & Degree
Paulo Criado, MD
Facility Name
IMC - Instituto de Moléstias Cardiovasculares Tatuí
City
Tatuí
State/Province
Sao Paulo
ZIP/Postal Code
18270-170
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katlin Sampaio
Phone
+55 1534511300
Email
katlin.sampaio@imctatui.com
First Name & Middle Initial & Last Name & Degree
Célia Pires
Facility Name
DCC 'Sveti Georgi' EOOD
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veska Vasileva
Phone
+359886862216
Email
veska_vassileva@abv.bg
First Name & Middle Initial & Last Name & Degree
Irida Vasileva
Facility Name
Ambulatory for specialized medical care - individual practice for specialized medical care - skin and venereal diseases
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iveta Dencheva
Phone
+358887330202
Email
iv.dencheva@abv.bg
First Name & Middle Initial & Last Name & Degree
Ivan Botev, MD
Facility Name
DCC "Alexandrovska" EOOD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivalina Stoyanova
Phone
+359892226081
Email
ivalina.stoyanova@rdservices.org
First Name & Middle Initial & Last Name & Degree
Snejina Vassileva
Facility Name
Medical Center Eurohealth EOOD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Violeta Zaharieva
Phone
+359886641164
Email
zaharievavioleta@gmail.com
First Name & Middle Initial & Last Name & Degree
Valentina Broshtilova-Nikolova
Facility Name
Alberta DermaSurgery Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Asbell
Phone
587-487-0187
Email
rebecca@raoderm.com
First Name & Middle Initial & Last Name & Degree
Jaggi Rao, MD
Facility Name
Brunswick Dermatology Center
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bethany MacKay
Phone
506-459-1808
Email
bethany@bdcmed.ca
First Name & Middle Initial & Last Name & Degree
Irina Turchin
Facility Name
DermEffects
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Poyntz
Phone
519-204-6868
Email
deresearch1@rogers.com
First Name & Middle Initial & Last Name & Degree
Wei Loo
Facility Name
North York Research, Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2N 3A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renne Husin
Phone
416-222-7546
Ext
109
Email
renne@bnderm.com
First Name & Middle Initial & Last Name & Degree
Firouzeh Niakosari, MD
Facility Name
K. Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Nadeau
Phone
519-579-9535
Email
cnadeau@kpappclinical.com
First Name & Middle Initial & Last Name & Degree
Ajith Cy, MD
Facility Name
Sanatorium Profesora Arenbergera
City
Praha 1
ZIP/Postal Code
110 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adela Gorna
Phone
+420 739 223 454
Email
adela.gorna@crc-cz.com
First Name & Middle Initial & Last Name & Degree
Petr Arenberger
Facility Name
Bispebjerg Hospital, Dermato-Venerologisk Afdeling Og Videncenter for Sårheling, D/S.
City
Copenhagen NV
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stine Oerts Pedersen
Phone
0045 21299349
Email
stine.oerts.pedersen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Mette Mogensen, MD
Facility Name
OUH
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette Juul
Phone
+45 6541 3620
Email
Mette.Juul@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Line Iversen
Facility Name
Sjællands Universitetshospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vibeke Haugaard
Phone
+4547322673
Email
vhau@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Gregor Jemec, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Daxdilimab (HZN-7734) in Patients With Moderate-to-Severe Primary Discoid Lupus Erythematosus

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