Systemic Lupus ErythematosusPhase 2RECAST SLE OLENCT05430854
Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study
A Phase 2 study testing Daxdilimab in people with Systemic Lupus Erythematosus, run by Amgen at 52 sites in 9 countries.
Trial summary
A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Daxdilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 52 sitesin 9 countries
- Study dates
- 1 Jun 2022to 31 Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to understand and provide written informed consent.
- Must have completed the treatment period in the RECAST SLE study.
- 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.
Who cannot join
- Any condition or change during the RECAST SLE study that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety or alter the risk-benefit associated with IP administration.
- Participation in another clinical study with an IP during the RECAST SLE study period.
- Planned elective surgeries that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety.
- Any herpes zoster, cytomegalovirus, or Epstein-Barr virus infection that was not completely resolved prior to Visit 1.
- Clinically significant active infection at Visit 1, in the opinion of the Investigator.
- Pregnant or lactating females.
Trial locations and contacts
52 sites in 9 countries.
52 sites in 9 countries
United States14 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn, New York, 11201
DJL Clinical Research
Charlotte, North Carolina, 28210-8509
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, 33765-2616
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034-5913
Metroplex Clinical Research Center
Dallas, Texas, 75231
Spectrum Medical, Inc
Danville, Virginia, 24541-1222
Bluegrass Community Research Inc
Lexington, Kentucky, 40504-2931
Southwest Rheumatology Research, LLC
Mesquite, Texas, 75150
Paramount Medical Research and Consulting LLC
Middleburg Heights, Ohio, 44130-3483
Millennium Research
Ormond Beach, Florida, 32174
IRIS Research and Development LLC
Plantation, Florida, 33324
Clinical Research of West Florida Inc - Tampa
Tampa, Florida, 33606-1246
Inland Rheumatology Clinical Trials Incorporated
Upland, California, 91786
Mexico9 sites
Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable
Guadalajara, Jalisco, 44160
Clinica de Investigacion en Reumatologia y Obesidad
Guadalajara, 44600
Centro de Estudios de Investigacion Basica Y Clinica SC
Jalisco, 44690
Morales Vargas Centro de Investigacion SC
León, Guanajuato, 37000
Centro Peninsular de Investigacion S.C.P
Mérida, Yucatán, 97000
Centro de Investigación en Artritis y Osteoporosis
Mexicali, Estado de Baja California
Consultorio de Reumatologia
Mexico City, 07760
Centro de Investigación y Tratamiento Reumatológico S.C
San Miguel, Mexico City, 11850
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Zapopan, Jalisco, 45030
Poland8 sites
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, 85-065
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, 30-363
Pratia MCM
Krakow, Lesser Poland Voivodeship, 30-510
Centrym Medyczne AMED oddzial w Lodzi
Lodz, Łódź Voivodeship, 91-365
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, Lubusz Voivodeship, 67-100
Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi
Poznan, Greater Poland Voivodeship, 61-545
Medycyna Kliniczna Marzena Waszczak-Jeka
Warsaw, Masovian Voivodeship, 00-874
Centrum Medyczne AMED
Warsaw, Masovian Voivodeship, 03-291
Argentina7 sites
Consultorios Médicos Dr. Doreski
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP
Clínica Adventista Belgrano
Estomba, Buenos Aires, C1430EGF
Framingham Centro Médico
La Plata, Buenos Aires, B1902COS
Instituto CER S.A
Quilmes, Buenos Aires, B1878DVB
Instituto de Investigaciones Clinicas Quilmes SRL
Quilmes, Buenos Aires, B1878GEG
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, T4000AXL
Consultorio de Investigaciones Reumatologicas
San Miguel de Tucumán, Tucumán Province, T4000AXL
India5 sites
AES - AS - Panchshil Hospital - Ahmedabad
Ahmedabad, Gujarat, 380005
AES - AS - Sushruta Multispeciality Hospital & Research Center Pvt Ltd - Hubli
Hubli, Karnataka, 580021
Jasleen Hospital
Nagpur, Maharashtra, 440012
Krishna Institute of Medical Sciences
Secunderabad, Andhra Pradesh, 500003
AES - AS - Unity Trauma Center and ICU - Unity Hospital - Surat
Surat, Gujarat, 395010
Greece4 sites
Athens General Hospital 'G Gennimatas
Athens, 115 27
Laiko General Hospital of Athens
Athens, 115 27
University General Hospital of Larissa
Larissa, 411 10
Kianous Stavros
Thessaloniki, 546 36
Serbia3 sites
Institute of Rheumatology Belgrade
Belgrade, 11000
Military Medical Academy
Belgrade, 11000
University Clinical Center Kragujevac
Kragujevac, 34000
Taiwan1 site
National Taiwan University Hospital
Taipei, Province of China, 100
About this study
Official title: An Open-Label Extension Study To Evaluate The Long- Term Safety And Tolerability Of Daxdilimab (Hzn-7734) In Subjects With Systemic Lupus Erythematosus
A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.
Read the detailed description
Approximately 156 participants will be enrolled to receive daxdilimab administered subcutaneously over 48 weeks. The maximum trial duration per participant is approximately 56 weeks, including the 48 weeks for the open-label treatment period where participants will receive daxdilimab and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study.
Acquired from Horizon in 2024.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Daxdilimab
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaxdilimabBiological
Also called HZN-7734
Daxdilimab will be administered subcutaneously as two injections for each dose.
| Study group | Role | What they receive |
|---|---|---|
| Daxdilimab | Experimental | Daxdilimab injections over a total of 48 weeks. Receives: Biological: Daxdilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP, whether or not considered related to the IP. A TEAE is defined as any AE with an onset date on or after the first dose date in the OLE study.
Measured: Up to approximately 56 weeks
Number of Participants Who Experienced Serious Adverse Events (SAEs)
An AE is considered "serious" if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes:
- Death
- A life-threatening AE
- Inpatient hospitalization or prolongation of existing hospitalization
- Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions
- A congenital abnormality/birth defect
- Important medical events judged to jeopardize the participant(s).
Measured: Up to approximately 56 weeks
Number of Participants Who Experienced AEs of Special Interest (AESI)
An AESI is an AE of scientific and medical interest specific to understanding of the IP and may require close monitoring and collection of additional information by the Investigator. In this study, AESIs were:
- Hypersensitivity reaction, including anaphylaxis
- Severe (Grade 3 or higher) viral infections/reactivations
- Opportunistic infections
- Malignancy (except non-melanoma skin cancer).
Measured: Up to approximately 56 weeks
Secondary outcomes (3)
Serum Concentration of Daxdilimab
Serum concentration of daxdilimab refers to the amount of daxdilimab present in the blood serum at a given time. Blood samples were collected via venipuncture at the specified time frames. Week 0 corresponds to the last day of the treatment period in the parent study and Day 1 of the treatment period in the OLE study.
Measured: Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56
Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count
PDCs count refers to the number of pDCs present in a blood sample. Blood samples were collected via venipuncture at the specified time frames. Week 0 corresponds to the last day of the treatment period in the parent study and Day 1 of the treatment period in the OLE study.
Measured: Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56
Number of Participants Expressing Anti-drug Antibodies (ADA)
ADA incidence is the number of the participants with ADA positive post-Baseline only or boosted their preexisting ADA during the trial. Persistent positive was defined as ADA positive at ≥ 2 post-Baseline assessments (with ≥ 16 weeks between first and last positive) or positive at last post-Baseline assessment. Transient positive was defined as ADA post-Baseline positive but did not fulfill the criteria of persistent positive.
Measured: Up to approximately 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Jun 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430854
- Sponsor's protocol ID
- HZNP-DAX-204
- Acronym
- RECAST SLE OLE
- Status last verified
- Aug 2024
- First submitted
- 20 Jun 2022
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study To Evaluate The Long- Term Safety And Tolerability Of Daxdilimab (Hzn-7734) In Subjects With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT05430854
- Acronym / sponsor ID
- RECAST SLE OLE / HZNP-DAX-204
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 155 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.
Detailed description
Approximately 156 participants will be enrolled to receive daxdilimab administered subcutaneously over 48 weeks. The maximum trial duration per participant is approximately 56 weeks, including the 48 weeks for the open-label treatment period where participants will receive daxdilimab and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study.
Acquired from Horizon in 2024.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daxdilimab | Experimental | Biological: DaxdilimabDaxdilimab injections over a total of 48 weeks. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing and able to understand and provide written informed consent.
- Must have completed the treatment period in the RECAST SLE study.
- 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 (6 listed)
- Any condition or change during the RECAST SLE study that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety or alter the risk-benefit associated with IP administration.
- Participation in another clinical study with an IP during the RECAST SLE study period.
- Planned elective surgeries that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety.
- Any herpes zoster, cytomegalovirus, or Epstein-Barr virus infection that was not completely resolved prior to Visit 1.
- Clinically significant active infection at Visit 1, in the opinion of the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaxdilimabAlso: HZN-7734Daxdilimab will be administered subcutaneously as two injections for each dose. | Biological | Daxdilimab |
Primary outcome
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 56 weeks
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP, whether or not considered related to the IP. A TEAE is defined as any AE with an onset date on or after the first dose date in the OLE study.
Number of Participants Who Experienced Serious Adverse Events (SAEs)
Time frame: Up to approximately 56 weeks
An AE is considered "serious" if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions * A congenital abnormality/birth defect * Important medical events judged to jeopardize the participant(s).
Number of Participants Who Experienced AEs of Special Interest (AESI)
Time frame: Up to approximately 56 weeks
An AESI is an AE of scientific and medical interest specific to understanding of the IP and may require close monitoring and collection of additional information by the Investigator. In this study, AESIs were: * Hypersensitivity reaction, including anaphylaxis * Severe (Grade 3 or higher) viral infections/reactivations * Opportunistic infections * Malignancy (except non-melanoma skin cancer).
3 secondary outcomes
Serum Concentration of Daxdilimab
Time frame: Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56
Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count
Time frame: Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56
Number of Participants Expressing Anti-drug Antibodies (ADA)
Time frame: Up to approximately 56 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
52 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daxdilimab in people with Systemic Lupus Erythematosus, run by Amgen at 52 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Mexico, Poland, Argentina, India and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) (time frame: Up to approximately 56 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.