RECAST SLE: Study of VIB7734 for the Treatment of Moderate to Severely Active SLE

• Sponsor: Viela Bio (acquired by Horizon Therapeutics) (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04925934
• Collaborator: (none)
• Enrollment: 214
• Locations: 89
• Arms: 3
• Anticipated Duration (Months): 27.2
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus in approximately 195 participants. The study duration will be 48 weeks, with a safety follow-up through week 56.There will be 3 parallel arms - 2 active treatment and 1 placebo.

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus, Systemic	Drug: VIB7734; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 214 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, double-blind, placebo-controlled, parallel-arm studyRandomized, double-blind, placebo-controlled, parallel-arm study
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus
• Actual Study Start Date: Jun 24, 2021
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VIB7734 SC (dosing interval 1)	Drug: VIB7734; VIB7734
Experimental: VIB7734 SC (dosing interval 2)	Drug: VIB7734; VIB7734
Placebo Comparator: Placebo SC (dosing interval 3)	Other: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Proportion of Participants who achieve BICLA and OGC (oral glucocorticoid) reduction response at Week 48 [Week 48]

   Participants will have BICLA (BILAG 2004 Index-Based Combined Lupus Assessment) and oral glucocorticoid assessment at week 48.

Secondary Outcome Measures

1. Proportion of Participants with CLASI-A score ≥ 10 at Baseline (Day 1) who achieve ≥ 50% reduction from Baseline (Day 1) in CLASI-A score at Week 12 [Week 12]

   Cutaneous Lupus Erythematosus Disease Area and Severity Index will be measured at week 12. The scoring consists of 2 parts: inflammatory activity of the disease and damage done by the disease.

2. Proportion of Participants achieving an SRI-4 response and an OGC dose ≤ 7.5 mg/day and ≤ Baseline (Day 1) dose of prednisone or equivalent at Week 48 [Week 48]

   The SRI-4 (SLE Responder Index) is defined as meeting all criteria compared to baseline, (e.g. no worsening of symptoms).

3. Proportion of Participants at OGC dose ≥ 10 mg prednisone or equivalent at Baseline (Day 1) who achieve an OCG of ≤ 7.5 mg/day prednisone or equivalent at Week 36 through Week 48 [Week 36 to Week 48]

4. Proportion of Participants achieving LLDAS (Lupus Low Disease Activity State) at Week 48 [Week 48]

   LLDAS is a composite measure of SLE disease activity that measures 5 criteria: SLEDAI-2K ≤ 4, with no activity in major organ systems, no new lupus disease activity, PGA ≤ 1 (scale 0 to 3), current prednisone (or equivalent) dose ≤ 7.5 mg daily, tolerated maintenance doses of immunosuppressive drugs and approved biological agents.

Other Outcome Measures

1. Number of Participants who experience AEs, SAEs, AESIs [Baseline through Week 60]

   Safety evaluation will occur throughout the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥ 18 years to ≤ 70 years

• Willing and able to understand and provide written informed consent.

• Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE

• Disease duration of at least 6 months

• Active SLE as indicated by presence of all the following:

1. SLEDAI-2K total score ≥ 6 at Screening, excluding fever, SLE headache, or organic brain syndrome.

2. SLEDAI-2K total score ≥ 4, excluding points attributable to any urine or laboratory results, immunologic measures, fever, SLE headache, or organic brain syndrome at Screening and Baseline (Day 1).

3. At least one of the following BILAG 2004 Index levels of disease at Screening:

• BILAG A disease in ≥ 1 organ system

• BILAG B disease in ≥ 2 organ systems d. PGA score ≥ 1 on a 0 to 3 visual analog scale (VAS) at Screening

Have at least one of the following at Screening per central lab:

• ANA ≥ 1:80

• Anti-dsDNA antibodies elevated to above normal range as established by the central laboratory (ie, positive results)

• Anti-Smith antibodies elevated to above normal (ie, positive results) Ongoing treatment for SLE

1. Treatment with one or more disease-modifying anti-rheumatic drug (DMARD) or immunosuppressive medication: Any of the following medications each administered at conventional anti-rheumatic doses for treatment of SLE for at least 12 weeks before Screening (unless discontinued or dose adjusted for documented drug-related toxicity or size/weight), and at a stable dose (including route of administration) for a minimum of 8 weeks prior to Screening and maintained through Baseline (Day 1):

2. Treatment with OGC monotherapy (without the concomitant use of DMARDs or immunosuppressants):

• Average daily dose of PO prednisone ≥ 10 mg but ≤ 40 mg (or prednisone equivalent) for a minimum of 4 weeks prior to Screening and a stable dose for minimum of 2 weeks prior to Screening. The dose of OGC must be kept for a minimum of 2 weeks prior to Randomization. Daily dosing or alternate day dosing of PO prednisone or equivalent is allowed.

• Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Randomization.

• Non-sterilized male participants who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Randomization and until 3 months (approximately 5 half-lives) after receipt of the last dose.

Exclusion Criteria:

• Any condition that, in the opinion of the Investigator, or the Sponsor/Central Review Committee, would interfere with the evaluation of the IP or interpretation of participant safety or study results (including borderline disease activity)

• History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or a previous mAb or human Ig therapy

• Active LN or active severe or unstable neuropsychiatric SLE

• Current diagnosis of non-SLE vasculitis syndrome, mixed connective tissue disease, or rheumatic (overlap) syndrome

• Participation in another clinical study with an investigational drug within 4 weeks before Day 1

• Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP

• Major surgery within 8 weeks prior to Screening or elective surgery planned from Screening through Day 393.

• Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks before Screening

• Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection

• Hepatitis B, Hepatitis C, active TB, any severe herpes infection, clinically active infection, or opportunistic infection

• History of clinically significant cardiac disease including unstable angina; and/or myocardial infarction and/or congestive heart failure within 6 months prior to Randomization.

• History of cancer within the past 5 years except, in situ carcinoma of the cervix, cutaneous basal cell or squamous cell carcinoma with curative therapy.

• Receipt of a live-attenuated vaccine within 4 weeks before Day 1 Administration of inactivated (killed) vaccines is acceptable

• The use of immunosuppressants, biologics and DMARDS within the protocol defined washout periods

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Diego Medical Center	La Jolla	California	United States	92037
2	Inland Rheumatology Clinical Trials Incorporated	Upland	California	United States	91786
3	Clinical Research of West Florida Inc - Clearwater	Clearwater	Florida	United States	33765-2616
4	Millennium Research	Ormond Beach	Florida	United States	32174
5	IRIS Research and Development LLC	Plantation	Florida	United States	33324
6	Clinical Research of West Florida Inc - Tampa	Tampa	Florida	United States	33606-1246
7	Emory University School of Medicine	Atlanta	Georgia	United States	30322
8	Bluegrass Community Research Inc	Lexington	Kentucky	United States	40504-2931
9	University of Maryland School of Medicine	Baltimore	Maryland	United States	20201
10	Logan Health Research	Kalispell	Montana	United States	59901-1912
11	NYU Langone Ambulatory Care Brooklyn Heights	Brooklyn	New York	United States	11201
12	Feinstein Institute For Medical Research	Manhasset	New York	United States	11030-3816
13	SUNY Upstate Medical Center	Syracuse	New York	United States	13210
14	DJL Clinical Research	Charlotte	North Carolina	United States	28210-8509
15	Medication Management LLC	Greensboro	North Carolina	United States	27408-7099
16	Paramount Medical Research and Consulting LLC	Middleburg Heights	Ohio	United States	44130-3483
17	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma	United States	73104
18	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
19	Tekton Research Inc	Austin	Texas	United States	78745-1485
20	Precision Comprehensive Clinical Research Solutions	Colleyville	Texas	United States	76034-5913
21	Metroplex Clinical Research Center	Dallas	Texas	United States	75231
22	Rheumatology Center of Houston	Houston	Texas	United States	77004
23	Southwest Rheumatology Research, LLC	Mesquite	Texas	United States	75150
24	Spectrum Medical, Inc	Danville	Virginia	United States	24541-1222
25	Consultorios Médicos Dr. Doreski	Ciudad Autónoma de Buenos Aires	Buenos Aires	Argentina	C1426ABP
26	Instituto CER S.A	Ciudad Autónoma de Buenos Aires	Buenos Aires	Argentina	C1426ABP
27	Clínica Adventista Belgrano	Estomba	Buenos Aires	Argentina	C1430EGF
28	Framingham Centro Médico	La Plata	Buenos Aires	Argentina	B1902COS
29	Instituto CER S.A	Quilmes	Buenos Aires	Argentina	B1878DVB
30	Instituto de Investigaciones Clinicas Quilmes SRL	Quilmes	Buenos Aires	Argentina	B1878GEG
31	Centro Medico Privado de Reumatologia	San Miguel De Tucumán	Tucumán	Argentina	T4000AXL
32	Consultorio de Investigaciones Reumatologicas	San Miguel De Tucumán	Tucumán	Argentina	T4000AXL
33	I.R. Medical Center - Hospital de Dia	Mendoza		Argentina	M5500CPH
34	Athens General Hospital 'G Gennimatas	Athens		Greece	115 27
35	Laiko General Hospital of Athens	Athens		Greece	115 27
36	Attikon University General Hospital	Athens		Greece	124 62
37	University General Hospital of Heraklion	Irákleio		Greece	711 10
38	University General Hospital of Larissa	Larisa		Greece	411 10
39	Kianous Stavros	Thessaloníki		Greece	546 36
40	Krishna Institute of Medical Sciences	Secunderabad	Andhra Pradesh	India	500003
41	King George Hospital	Visakhapatnam	Andhra Pradesh	India	530002
42	Regional Cancer Centre Indira Gandhi Institute of Medical Sciences	Patna	Bihar	India	800014
43	AES - AS - Panchshil Hospital - Ahmedabad	Ahmedabad	Gujarat	India	380005
44	AES - AS - Unity Trauma Center and ICU - Unity Hospital - Surat	Sūrat	Gujarat	India	395010
45	AES - AS - Sushruta Multispeciality Hospital & Research Center Pvt Ltd - Hubli	Hubli	Karnataka	India	580021
46	Jasleen Hospital	Nagpur	Maharashtra	India	440012
47	AES - AS - Fortis Escorts Hospital - Jaipur	Jaipur	Rajasthan	India	302017
48	Centro de Investigación en Artritis y Osteoporosis	Mexicali	Baja California	Mexico	21200
49	Centro de Investigación y Tratamiento Reumatológico S.C	San Miguel	Distrito Federal	Mexico	11850
50	Morales Vargas Centro de Investigacion SC	León	Guanajuato	Mexico	37000
51	Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable	Guadalajara	Jalisco	Mexico	44160
52	Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.	Zapopan	Jalisco	Mexico	45030
53	Centro Peninsular de Investigacion S.C.P	Merida	Yucatán	Mexico	97000
54	Consultorio de Reumatologia	Ciudad de Mexico		Mexico	07760
55	AMAF Clinical Research,S.C.	Distrito Federal		Mexico	06760
56	Clinica de Investigacion en Reumatologia y Obesidad	Guadalajara		Mexico	44600
57	Centro de Estudios de Investigacion Basica Y Clinica SC	Jalisco		Mexico	44690
58	Centrym Medyczne AMED oddzial w Lodzi	Łódź	Lodzkie	Poland	91-365
59	Zespol Poradni Specjalistycznych REUMED	Lublin	Lubelskie	Poland	20-582
60	Twoja Przychodnia - Centrum Medyczne Nowa Sol	Nowa Sól	Lubuskie	Poland	67-100
61	Pratia MCM	Krakow	Malopolskie	Poland	30-510
62	Centrum Medyczne Plejady	Kraków	Malopolskie	Poland	30-363
63	NZOZ Lecznica MAK-MED	Nadarzyn	Mazowieckie	Poland	05-830
64	NBR Polska	Warszawa	Mazowieckie	Poland	00-465
65	Medycyna Kliniczna Marzena Waszczak-Jeka	Warszawa	Mazowieckie	Poland	00-874
66	Rheuma Medicus Specjalistyczne Centrum Reumatologii i Osteoporozy	Warszawa	Mazowieckie	Poland	00-874
67	Centrum Medyczne AMED	Warszawa	Mazowieckie	Poland	03-291
68	Centrum Medyczne Czestochowa - PRATIA	Czestochowa	Slaskie	Poland	42-200
69	Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi	Poznań	Wielkopolskie	Poland	61-545
70	Nasz Lekarz Osrodek Badan Klinicznych	Bydgoszcz		Poland	85-065
71	Belyayev Clinical Hospital of the Kuzbass	Kemerovo		Russian Federation	650066
72	O.M. Filatov City Clinical Hospital #15	Moscow		Russian Federation	111539
73	Departmental Hospital at Smolensk Station "rzhd" JSC	Smolensk		Russian Federation	214025
74	Institute of Rheumatology Belgrade	Belgrade		Serbia	11000
75	Military Medical Academy	Belgrade		Serbia	11000
76	University Clinical Center Kragujevac	Kragujevac		Serbia	34000
77	Institute Niska Banja	Niška Banja		Serbia	708120
78	Hospital Universitario A Coruña	A Coruña		Spain	15006
79	Hospital Universitario Ramon y Cajal	Madrid		Spain	28034
80	Hospital Quironsalud Infanta Luisa	Sevilla		Spain	41010
81	Kaohsiung Veterans General Hospital	Kaohsiung City	Province Of China	Taiwan	81362
82	National Taiwan University Hospital	Taipei	Province Of China	Taiwan	100
83	Chang Gung Memorial Hospital, Linkou	Taoyuan	Province Of China	Taiwan	333
84	Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital	Kaohsiung City		Taiwan	833
85	Communal Nonprofit Enterprise Regional Clinical Hospital of the Ivano-Frankivsk Regional Council	Ivano-Frankivsk	Ivano-Frankivs'ka Oblast	Ukraine	76001
86	Medical Center of LLC Modern Clinic	Zaporizhzhia	Zaporiz'ka Oblast	Ukraine	69005
87	Medical Center of LLC Medical Clinic Blagomed	Kyiv		Ukraine	01023
88	Limited Liability Company Medical Center Consilium	Kyïv		Ukraine	04050
89	ME Poltava Reg.Clin.Hospital n.a.M.V.Skliphosovskyi of Poltava Reg.Council	Poltava		Ukraine	36024

Sponsors and Collaborators

• Viela Bio (acquired by Horizon Therapeutics)

Investigators

• Study Director: Rob Ortmann, MD, Horizon Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Viela Bio (acquired by Horizon Therapeutics)
• ClinicalTrials.gov Identifier: NCT04925934
• Other Study ID Numbers: VIB7734.P2.S1; 2020-005528-12
• First Posted: Jun 14, 2021
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic

Study Results

No Results Posted as of Aug 15, 2022