ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements.
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04058028

Registration number

NCT04058028

Ethics application status

Date submitted

30/07/2019

Date registered

15/08/2019

Titles & IDs

Public title

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

Scientific title

A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy

Secondary ID [1]

20170588

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Systemic Lupus Erythematosus (SLE)

Condition category

Condition code

Human Genetics and Inherited Disorders

Other human genetics and inherited disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - Rozibafusp Alfa
Treatment: Drugs - Placebo for Rozibafusp Alfa

Experimental: Rozibafusp Alfa, Dose A - Investigational product solution in vial

Experimental: Rozibafusp Alfa, Dose B - Investigational product solution in vial

Experimental: Rozibafusp Alfa, Dose C - Investigational product solution in vial

Placebo comparator: Placebo for Rozibafusp Alfa - Placebo Investigational product solution in vial

Treatment: Drugs: Rozibafusp Alfa
Rozibafusp Alfa will be presented in 5 mL glass vial

Treatment: Drugs: Placebo for Rozibafusp Alfa
Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52

Assessment method [1]

SRI-4 response at Week 52 is defined as a = 4-point decrease in the hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score, and no new British Isles Lupus Assessment Group (BILAG) 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to 3), and no use of more than protocol allowed therapies.

Timepoint [1]

Week 52

Secondary outcome [1]

Number of Participants With a SRI-4 Response at Week 24

Assessment method [1]

SRI-4 response at Week 24 is defined as a = 4-point decrease in the hSLEDAI score, and no new BILAG 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in PGA (scale 0 to 3), and no use of more than protocol allowed therapies.

Timepoint [1]

Week 24

Secondary outcome [2]

Number of Participants Who Achieved a BILAG Based Combined Lupus Assessment (BICLA) Response at Week 24

Assessment method [2]

The BICLA response is defined as: 1. An improvement in baseline BILAG domain scores across all body systems with moderate (domain B) or severe disease activity (domain A) 2. No new BILAG 2004 A domain score and no \> 1 new BILAG 2004 B domain scores compared with baseline 3. No worsening of the hSLEDAI score from baseline 4. No = 0.3-point deterioration from baseline in PGA 5. No use of more than protocol-allowed therapies 6. No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants.

Timepoint [2]

Week 24

Secondary outcome [3]

Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52

Assessment method [3]

LLDAS was defined as meeting all the following conditions: 1. hSLEDAI = 4, with no activity in major organ system (renal, central nervous system \[CNS\], cardiopulmonary, vasculitis, fever) and hemolytic anemia or gastrointestinal activity 2. No new lupus disease activity as compared with the previous assessment 3. PGA = 1 (on a scale of 0 to 3) 4. Current prednisone or equivalent dose of = 7.5 mg/day 5. Well-tolerated standard maintenance doses of immunosuppressive drugs and approved treatments, as allowed and specified in the protocol.

Timepoint [3]

Week 52

Secondary outcome [4]

Number of Participants Who Achieved a BICLA Response at Week 52

Assessment method [4]

Timepoint [4]

Week 52

Secondary outcome [5]

Number of Participants Achieving a SRI-4 Response With a Reduction of Oral Corticosteroids (OCS) to = 7.5 mg/Day by Week 44 and Sustained Through Week 52 In Participants With a Baseline OCS Dose = 10 mg/Day

Assessment method [5]

SRI-4 response is defined as a = 4-point decrease in the hSLEDAI score, and no new BILAG 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in PGA (scale 0 to 3), and no use of more than protocol allowed therapies. Participants also had to meet a reduction if OCS to = 7.5 mg/day by Week 44 sustained through Week 52.

Timepoint [5]

Up to Week 52

Secondary outcome [6]

Annualized Moderate and Severe Flare Rate Over 52 Weeks as Measured by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment [SELENA] -Systemic Lupus Erythematosus Disease Activity Index [SLEDAI] Flare Index (SFI)

Assessment method [6]

The SFI, serves as a composite outcome measure incorporating the SELENA-SLEDAI score, and classifications of flares into mild, moderate, and severe, along with the PGA of disease activity. The SFI details specific clinical manifestations for each organ system and categorizes flares into mild, moderate, and severe based on treatment decisions. Moderate and severe flare: • Moderate: meeting criteria like SELENA-SLEDAI score change of 3 to 12 points, SLE symptom development, prednisone dose increase, non-steroidal anti-inflammatory drugs (NSAIDs)/hydrochloroquine addition, or PGA score increase by 1 to 2.5. • Severe: meeting criteria like SELENA-SLEDAI increase over 12 points, onset or worsening of severe symptoms, significant prednisone dose escalation, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher. Annualized flare rate was calculated as the number of flares divided by flare exposure time in days, multiplied by 365.25 for each Group.

Timepoint [6]

Up to Week 52

Secondary outcome [7]

Annualized Severe Flare Rate Over 52 Weeks as Measured by SFI

Assessment method [7]

The SFI, serves as a composite outcome measure incorporating the SELENA-SLEDAI score, and classifications of flares into mild, moderate, and severe, along with the PGA of disease activity. The SFI details specific clinical manifestations for each organ system and categorizes flares into mild, moderate, and severe based on treatment decisions. Severe flare: meeting criteria like SELENA-SLEDAI increase over 12 points, onset or worsening of severe symptoms, significant prednisone dose escalation, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days, multiplied by 365.25 for each Group.

Timepoint [7]

Up to Week 52

Secondary outcome [8]

Annualized Flares Rate Over 52 Weeks as Measured by BILAG Score Designation of "Worse" or "New" Resulting in a B-Score In = 2 Organs or an A-Score in = 1 Organ

Assessment method [8]

The BILAG flare index was derived from BILAG 2004, as measured by BILAG score designation of 'worse' or 'new' resulting in a B score in \>= 2 organs or an A score in \>= 1 organ. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days, multiplied by 365.25 for each Group.

Timepoint [8]

Up to Week 52

Secondary outcome [9]

Number of Participants With =6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving =50% Improvement From Baseline at Weeks 12, 24, 36, and 52

Assessment method [9]

The tender and swollen joint count is a physical assessment where for each swollen and tender joint a score of 1 is assigned. Scores are then summed up to provide a total score for both swollen and tender joints. Higher total score indicate a severe disease activity and a lower score indicates a lees severe disease activity.

Timepoint [9]

Week 12, 24, 36, and 52

Secondary outcome [10]

Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score =8 at Baseline Achieving =50% Improvement From Baseline at Weeks 12, 24, 36, and 52

Assessment method [10]

The CLASI is an assessment tool consisting of two scores: one for disease activity and one for damage. Activity Score: Ranges from 0 to 70, and is assessed based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss, and non-scarring alopecia. Higher scores indicate more severe disease activity. Damage Score: Ranges from 0 to 56, and is evaluated through dyspigmentation and scarring, including scarring alopecia. Dyspigmentation that remains visible for more than 12 months is considered permanent, and its score is doubled. Higher scores indicate greater damage.

Timepoint [10]

Week 12, 24, 36, and 52

Secondary outcome [11]

Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52

Assessment method [11]

The PROMIS-Fatigue SF7a is a 7-item instrument that assesses the experience of fatigue as well as its impact on physical, mental and social activities. Each item is scored on a 5-point Likert scale, ranging from "1" (Never) to "5" (Always). The scores of all 7 items are summed up with a total raw score range of 7(low level of fatigue)-35(high level of fatigue). Raw scores are converted to a T-score ranging from 29.4(low level of fatigue)-83.2(high level of fatigue).

Timepoint [11]

Week 12, 24, 36, 44, and 52

Secondary outcome [12]

Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52

Assessment method [12]

The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.

Timepoint [12]

Week 12, 24, 36, 44, and 52

Secondary outcome [13]

Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52

Assessment method [13]

Timepoint [13]

Week 12, 24, 36, 44, and 52

Secondary outcome [14]

Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52

Assessment method [14]

Timepoint [14]

Week 12, 24, 36, 44, and 52

Secondary outcome [15]

Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52

Assessment method [15]

Timepoint [15]

Week 12, 24, 36, 44, and 52

Secondary outcome [16]

Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52

Assessment method [16]

Timepoint [16]

Week 12, 24, 36, 44, and 52

Secondary outcome [17]

Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52

Assessment method [17]

Timepoint [17]

Week 12, 24, 36, 44, and 52

Secondary outcome [18]

Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52

Assessment method [18]

Timepoint [18]

Week 12, 24, 36, 44, and 52

Secondary outcome [19]

Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52

Assessment method [19]

Timepoint [19]

Week 12, 24, 36, 44, and 52

Secondary outcome [20]

Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52

Assessment method [20]

Timepoint [20]

Week 12, 24, 36, 44, and 52

Secondary outcome [21]

Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52

Assessment method [21]

Timepoint [21]

Week 12, 24, 36, 44, and 52

Secondary outcome [22]

Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52

Assessment method [22]

The LupusQoL questionnaire consists of 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Each item in the questionnaire is scored on a 5 point scale and items within a given domain are summed and converted to a 0-100 scale. Each domain is scored 0-100 with higher scores representing better quality of life in the specific domain. Lower scores signify poorer quality of life within the domain.

Timepoint [22]

Week 12, 24, 36, 44, and 52

Secondary outcome [23]

Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52

Assessment method [23]

The PtGA assesses disease activity on a 10 cm numeric rating scale (NRS; 0 to 10 cm). The scale for the assessment ranges from "very well" (0) to "very poor" (10).

Timepoint [23]

Week 12, 24, 36, 44, and 52

Secondary outcome [24]

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

Assessment method [24]

An adverse event (AE) was any negative medical occurrence linked to an intervention in humans, regardless of its relation to the intervention. Treatment-emergent AEs (TEAEs) were those that occurred after the first intervention dose. A serious adverse event (SAE) included outcomes such as death, life-threatening situations, hospitalization or an extended hospital stay, significant incapacity, congenital defects, or other crucial medical events. AE severity followed the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 scale: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death). Clinically significant laboratory results or other assessments (e.g., ECGs, scans, vital signs) that worsened from baseline and were deemed important by the investigator, independent of disease progression, were also considered.

Timepoint [24]

Up to approximately 68 weeks

Secondary outcome [25]

Serum Concentration of Rozibafusp Alfa

Assessment method [25]

Timepoint [25]

Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 36, Week 44, Week 52, Week 56, Week 60, Week 64, and Week 68

Secondary outcome [26]

Terminal Half-life of Rozibafusp Alfa

Assessment method [26]

Timepoint [26]

Up to Week 68

Eligibility

Key inclusion criteria

Inclusion Criteria Screening Visit:

* Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
* Age = 18 years to = 75 years at screening visit.
* Fulfills classification criteria for SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE (Aringer et al, 2019), with antinuclear antibody = 1:80 by immunofluorescence on Hep-2 cells being present at screening.
* Hybrid SLEDAI score = 6 points with a "Clinical" hSLEDAI score = 4 points. The "Clinical" hSLEDAI is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results, including urine or immunologic parameters.
* Additional protocol-specific rules are applied at screening and throughout the study, as follows:

* Arthritis: Arthritis (at least 3 tender and swollen joints) must involve joints in the hands or wrists for the hSLEDAI scoring.
* Alopecia: Subjects should have hair loss without scarring; should neither have alopecia areata nor androgenic alopecia; and should have a CLASI activity score for alopecia = 2.
* Oral ulcers: Ulcers location and appearance must be documented by the investigator.
* Scleritis and Episcleritis: the presence of stable SLE-related scleritis and episcleritis must be documented by an ophthalmologist and other causes excluded.
* Renal: subjects with urine protein/creatinine ratio < 3000 mg/g (or equivalent method) in a clear catch spot urine sample can enroll and be scored in the hSLEDAI, provided the subject has a clinical hSLEDAI = 4 and did not receive induction treatment for nephritis within the last year.
* Pleurisy and Pericarditis: symptoms of pleurisy and pericarditis must be accompanied by objective findings to be scored in the hSLEDAI.
* Unless there is a documented intolerance, subjects must be taking:

* Only 1 of the following SLE treatments: anti-malarial (hydroxychloroquine, chloroquine, or quinacrine), azathioprine, methotrexate, leflunomide, mycophenolate mofetil/acid mycophenolic, or dapsone.

OR

• 2 of the above-mentioned SLE treatments in which 1 must be anti-malarial (hydroxychloroquine, chloroquine, or quinacrine).

* Treatment should be taken for = 12 weeks prior to screening and must be a stable dose for = 8 weeks prior to screening.
* For subjects taking OCS, dose must be = 20 mg/day of prednisone or OCS equivalent, and the dose must be stable at baseline visit for = 2 weeks prior to screening visit.

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion Criteria Screening Visit

Subjects are excluded from the study if any of the following criteria apply:

Disease Related

* Urine protein creatinine ratio = 3000 mg/g (or equivalent) at screening or induction therapy for lupus nephritis within 1 year prior to screening visit.
* Active CNS lupus within 1 year prior to screening including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

19/02/2020

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

25/07/2023

Sample size

Target

Accrual to date

Final

244

Recruitment in Australia

Recruitment state(s)

NSW,SA

Recruitment hospital [1]

Holdsworth House Medical Practice - Sydney

Recruitment hospital [2]

The Queen Elizabeth Hospital - Woodville South

Recruitment postcode(s) [1]

2010 - Sydney

Recruitment postcode(s) [2]

5011 - Woodville South

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Alabama

Country [2]

United States of America

State/province [2]

Arizona

Country [3]

United States of America

State/province [3]

California

Country [4]

United States of America

State/province [4]

Colorado

Country [5]

United States of America

State/province [5]

Connecticut

Country [6]

United States of America

State/province [6]

Florida

Country [7]

United States of America

State/province [7]

Georgia

Country [8]

United States of America

State/province [8]

Illinois

Country [9]

United States of America

State/province [9]

Louisiana

Country [10]

United States of America

State/province [10]

Maryland

Country [11]

United States of America

State/province [11]

New York

Country [12]

United States of America

State/province [12]

North Carolina

Country [13]

United States of America

State/province [13]

Oklahoma

Country [14]

United States of America

State/province [14]

Pennsylvania

Country [15]

United States of America

State/province [15]

South Carolina

Country [16]

United States of America

State/province [16]

Tennessee

Country [17]

United States of America

State/province [17]

Texas

Country [18]

Argentina

State/province [18]

Buenos Aires

Country [19]

Argentina

State/province [19]

Distrito Federal

Country [20]

Argentina

State/province [20]

Tucuman

Country [21]

Argentina

State/province [21]

San Juan

Country [22]

Bulgaria

State/province [22]

Plovdiv

Country [23]

Bulgaria

State/province [23]

Sofia

Country [24]

Bulgaria

State/province [24]

Stara Zagora

Country [25]

Canada

State/province [25]

Alberta

Country [26]

Canada

State/province [26]

Manitoba

Country [27]

Canada

State/province [27]

Quebec

Country [28]

Czechia

State/province [28]

Praha 2

Country [29]

France

State/province [29]

Bordeaux

Country [30]

France

State/province [30]

Caen Cedex 9

Country [31]

France

State/province [31]

Dijon Cedex

Country [32]

France

State/province [32]

Lille cedex 01

Country [33]

France

State/province [33]

Paris

Country [34]

France

State/province [34]

Reims Cedex

Country [35]

France

State/province [35]

Strasbourg

Country [36]

France

State/province [36]

Toulouse Cedex 9

Country [37]

France

State/province [37]

Toulouse

Country [38]

Germany

State/province [38]

Bad Kreuznach

Country [39]

Germany

State/province [39]

Leipzig

Country [40]

Greece

State/province [40]

Athens

Country [41]

Greece

State/province [41]

Heraklion

Country [42]

Greece

State/province [42]

Patra

Country [43]

Hong Kong

State/province [43]

New Territories

Country [44]

Hungary

State/province [44]

Debrecen

Country [45]

Hungary

State/province [45]

Gyula

Country [46]

Hungary

State/province [46]

Szekesfehervar

Country [47]

Italy

State/province [47]

Milano

Country [48]

Italy

State/province [48]

Pisa

Country [49]

Italy

State/province [49]

Roma

Country [50]

Italy

State/province [50]

Rozzano MI

Country [51]

Japan

State/province [51]

Chiba

Country [52]

Japan

State/province [52]

Fukuoka

Country [53]

Japan

State/province [53]

Gifu

Country [54]

Japan

State/province [54]

Hokkaido

Country [55]

Japan

State/province [55]

Hyogo

Country [56]

Japan

State/province [56]

Ishikawa

Country [57]

Japan

State/province [57]

Miyagi

Country [58]

Japan

State/province [58]

Nagano

Country [59]

Japan

State/province [59]

Nagasaki

Country [60]

Japan

State/province [60]

Okayama

Country [61]

Japan

State/province [61]

Shizuoka

Country [62]

Japan

State/province [62]

Tokyo

Country [63]

Korea, Republic of

State/province [63]

Daegu

Country [64]

Korea, Republic of

State/province [64]

Seoul

Country [65]

Korea, Republic of

State/province [65]

Suwon-si, Gyeonggi-do

Country [66]

Mexico

State/province [66]

Baja California Norte

Country [67]

Mexico

State/province [67]

Guanajuato

Country [68]

Mexico

State/province [68]

Jalisco

Country [69]

Mexico

State/province [69]

Yucatán

Country [70]

Mexico

State/province [70]

Ciudad de Mexico

Country [71]

Poland

State/province [71]

Gdansk

Country [72]

Poland

State/province [72]

Gdynia

Country [73]

Poland

State/province [73]

Katowice

Country [74]

Poland

State/province [74]

Krakow

Country [75]

Poland

State/province [75]

Lodz

Country [76]

Poland

State/province [76]

Lublin

Country [77]

Poland

State/province [77]

Poznan

Country [78]

Poland

State/province [78]

Stalowa Wola

Country [79]

Poland

State/province [79]

Warszawa

Country [80]

Poland

State/province [80]

Wroclaw

Country [81]

Portugal

State/province [81]

Almada

Country [82]

Portugal

State/province [82]

Lisboa

Country [83]

Portugal

State/province [83]

Porto

Country [84]

Russian Federation

State/province [84]

Ekaterinburg

Country [85]

Russian Federation

State/province [85]

Kazan

Country [86]

Russian Federation

State/province [86]

Kemerovo

Country [87]

Russian Federation

State/province [87]

Moscow

Country [88]

Russian Federation

State/province [88]

Novosibirsk

Country [89]

Russian Federation

State/province [89]

Saint Petersburg

Country [90]

Spain

State/province [90]

Andalucía

Country [91]

Spain

State/province [91]

Cataluña

Country [92]

Spain

State/province [92]

Galicia

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Amgen

Country

Ethics approval

Ethics application status

Summary

Brief summary

The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.

Trial website

https://clinicaltrials.gov/study/NCT04058028

Trial related presentations / publications

Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

Public notes

Contacts

Principal investigator

Name

Address

Amgen

Country

Phone

Contact person for public queries

Name

Address

Country

Phone

Contact person for scientific queries

Data sharing statement

What supporting documents are/will be available?

Type	Other Details	Attachment
Study protocol
Statistical analysis plan

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT04058028

Register a trial

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04058028