TAB08 in Patients With Systemic Lupus Erythematosus (SLE)... | NCT02711813

Studies
TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment

NCT02711813

Sponsor

Theramab LLC

Status

Terminated

Last Update Posted

May 23, 2018Actual

Enrollment

60Actual

Phase

Phase 2

Conditions

Lupus Erythematosus, Systemic

Interventions

TAB08
Placebo

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Administrative reasons

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

May 2018Actual

Completion Date

May 2018Actual

First Submitted Date

Mar 14, 2016

First Submission Date that Met QC Criteria

Mar 16, 2016

First Posted Date

Mar 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2018

Last Update Posted Date

May 23, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess whether TAB08 may be beneficial compared to placebo in patients with active Systemic Lupus Erythematosus, not adequately controlled with current concomitant treatment. Secondary purpose is to assess efficacy, safety, pharmacokinetic and pharmacodynamic parameters in this study population.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo to TAB08	Other: Placebo
TAB08 Dose 1	Experimental		Drug: TAB08
TAB08 Dose 2	Experimental		Drug: TAB08

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAB08	Drug	biologic	TAB08 Dose 1 TAB08 Dose 2
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number and proportion of treatment responders per SLE Responder Index (SRI)		24 weeks
Adverse Events		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Patient-reportet health outcome assessed by Short Form - 36 questionnaire (SF-36)		24 weeks
Area and severity of SLE skin damage by Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)		24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of Lupus Erythematosus according to American College of Rheumatology (ACR) criteria (4 of 11)
Active SLE (SLE Disease Activity Index ≥ 6)
Skin or joint SLE manifestations

Exclusion Criteria:

Lupus-nephritis and/or central nervous system affection (neuro-lupus)
Prohibited treatment
Pregnant or nursing women
Concomitant systemic therapy dosage modification (if any) within 4 weeks before randomization

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniil Nemenov, M.D.	Theramab LLC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federal State Budget Institution "Research Institute of Rheumatology of V.A. Nasonova" Russian Academy of Medical Sciences		Moscow			Russia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33687069	Derived	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.

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases