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The purpose of this study is to evaluate the safety and efficacy of repeated intravenous infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE) compared with people who receive a placebo.
Study 990 is a Phase IIa, proof-of-concept study of BT063 in subjects with SLE. This study is divided into 2 parts. After Part I an interim analysis will be performed. Each Part will enrol 18 subjects. Subjects will be randomly assigned to receive BT063 or Placebo 8 times over 12 weeks and will be followed for 4 months after their last dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BT063 | Experimental | 50 mg BT063 administered by intravenous (IV) infusion 8 times |
|
| Placebo | Placebo Comparator | Placebo administered by IV infusion 8 times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BT063 | Biological | Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Number of Participants with Adverse Events (Including SAEs and AEs leading to discontinuation) from Baseline through End of Trial Visit (Week 14) | Baseline through End of Trial Visit (Week 14) |
| Number of Participants With Changes of Safety Parameters | Number of Participants with changes in vital signs, ECGs, Safety laboratory parameters (full blood count including white differential count, clinical chemistry, thyroid hormones, urinalysis, and faecal occult blood test), Development of anti-drug antibodies against BT063 (anti-BT063), Immunological status of potential viral and bacterial infections (HBV, HCV, HIV, tetanus, diphtheria tuberculosis), EBV / CMV Serology, Premature withdrawals. | Baseline through End of Trial Visit (Week 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Improvements of Joints | Number of Participants with 50% improvement of swollen/tender joints. A total of 66/68 joints was assessed for the swollen/tender joint count. A joint that is normal (no tenderness or swelling), without signs of inflammation will be graded as 0. A joint with tenderness will be graded as 1 for tender joint count and a joint with swelling will be graded as 1 for swollen joint count. Joints suspected or known to have ischemic osteonecrosis are not to be taken into consideration. Higher scores indicate more disease activity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nemanja Damjanov, Professor | Institute of Rheumatology, University of Belgrade School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site 37505 | Homyel | Belarus | ||||
| Study Site 37501 |
| 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. |
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In total 36 subjects were enrolled in study parts I and II (18 in part I and 18 in part II). 12 subjects in part I received 50 mg BT063, 12 subjects in part II received 100 mg BT063. 6 subjects in part I and 6 subjects in part II received Placebo and were pooled for analysis. Only final results and no partial or interim results are presented.
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| ID | Title | Description |
|---|---|---|
| FG000 | BT063 50 mg | 50 mg BT063 administered by intravenous (IV) infusion 8 times BT063: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12) |
| FG001 | BT063 100 mg | 100 mg BT063 administered by intravenous (IV) infusion 8 times BT063: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12) |
| FG002 | Placebo | Placebo administered by IV infusion 8 times Placebo: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | BT063 50 mg | 50 mg BT063 administered by intravenous (IV) infusion 8 times BT063: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12) |
| BG001 | BT063 100 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Number of Participants with Adverse Events (Including SAEs and AEs leading to discontinuation) from Baseline through End of Trial Visit (Week 14) | Posted | Count of Participants | Participants | Baseline through End of Trial Visit (Week 14) |
|
Incidence of AEs (including SAEs and AEs leading to discontinuation) from baseline through End of Trial Visit (Week 14)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BT063 50 mg | 50 mg BT063 administered by intravenous (IV) infusion 8 times BT063: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment | mild; not related; recovered |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ASTHENIA | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Röttgen | Biotest AG | +496103801 | 803 | peter.roettgen@biotest.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 19, 2015 | Aug 2, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2018 | Aug 2, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Placebo |
| Biological |
Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12) |
|
| At week14 and week 28 |
| Number of Participants With Improvement of Skin | Number of Participants with 50% improvement in Cutaneous Lupus Erythematosus Disease Area and Sensitivity Index (CLASI) Activity score. The CLASI is an assessment over 13 body regions (scalp, ears, nose - including malar area, rest of the face, V-area neck - frontal, post. neck & shoulders, chest, abdomen, back and buttocks, arms, hands, legs, feet) and consists of 2 scores: total activity score and total damage score. Only the activity score was used in this study. The minimum score possible on this scale is 0 and the maximum score is 70. The higher scores mean a worse outcome. | At week14 and week 28 |
| Percent Changes in Systemic Lupus Erythematosus Disease Activity Index 2000 | Percent changes in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline SLEDAI-2K score. The SLEDAI-2K is a global index that measures SLE disease activity. It includes 24 items for the 9 organs/systems. Scores range from 0 to 105; a score of 6 is considered clinically important. The index measures disease activity within the last 10 days. Higher scores mean worse outcome. Negative percent change means reduced disease activity. | Baseline to week 14 and at week 28 |
| Minsk |
| Belarus |
| Study Site 37502 | Minsk | Belarus |
| Study Site 37503 | Minsk District | Belarus |
| Study Site 37504 | Vitebsk | Belarus |
| Study Site 99501 | Tbilisi | Georgia |
| Study Site 99502 | Tbilisi | Georgia |
| Study Site 48003 | Bialystok | Poland |
| Study Site 48004 | Krakow | Poland |
| Study Site 48002 | Poznan | Poland |
| Study Site 48001 | Warsaw | Poland |
| Study Site 38101 | Belgrade | Serbia |
| Study Site 38103 | Belgrade | Serbia |
| Study Site 38102 | Niška Banja | Serbia |
100 mg BT063 administered by intravenous (IV) infusion 8 times
BT063: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)
| BG002 | Placebo | Placebo administered by IV infusion 8 times Placebo: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 |
| Placebo |
Placebo administered by IV infusion 8 times Placebo: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12) |
|
|
| Primary | Number of Participants With Changes of Safety Parameters | Number of Participants with changes in vital signs, ECGs, Safety laboratory parameters (full blood count including white differential count, clinical chemistry, thyroid hormones, urinalysis, and faecal occult blood test), Development of anti-drug antibodies against BT063 (anti-BT063), Immunological status of potential viral and bacterial infections (HBV, HCV, HIV, tetanus, diphtheria tuberculosis), EBV / CMV Serology, Premature withdrawals. | Posted | Count of Participants | Participants | Baseline through End of Trial Visit (Week 14) |
|
|
|
| Secondary | Number of Participants With Improvements of Joints | Number of Participants with 50% improvement of swollen/tender joints. A total of 66/68 joints was assessed for the swollen/tender joint count. A joint that is normal (no tenderness or swelling), without signs of inflammation will be graded as 0. A joint with tenderness will be graded as 1 for tender joint count and a joint with swelling will be graded as 1 for swollen joint count. Joints suspected or known to have ischemic osteonecrosis are not to be taken into consideration. Higher scores indicate more disease activity. | Intension-To-Treat Set included 36 subjects (12 of each Group). At week 14, 1 subject in Placebo Group had no end of Treatment result; at week 28, 1 subject of 50 mg and 2 subjects of Placebo had no results. The efficacy outcome was based on observed cases. | Posted | Count of Participants | Participants | At week14 and week 28 |
|
|
|
| Secondary | Number of Participants With Improvement of Skin | Number of Participants with 50% improvement in Cutaneous Lupus Erythematosus Disease Area and Sensitivity Index (CLASI) Activity score. The CLASI is an assessment over 13 body regions (scalp, ears, nose - including malar area, rest of the face, V-area neck - frontal, post. neck & shoulders, chest, abdomen, back and buttocks, arms, hands, legs, feet) and consists of 2 scores: total activity score and total damage score. Only the activity score was used in this study. The minimum score possible on this scale is 0 and the maximum score is 70. The higher scores mean a worse outcome. | Intension-To-Treat Set included 36 subjects (12 of each Group). At week 14, 1 subject in Placebo Group had no end of Treatment result; at week 28, 1 subject of 50 mg and 2 subjects of Placebo had no results. The efficacy outcome was based on observed cases. | Posted | Count of Participants | Participants | At week14 and week 28 |
|
|
|
| Secondary | Percent Changes in Systemic Lupus Erythematosus Disease Activity Index 2000 | Percent changes in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline SLEDAI-2K score. The SLEDAI-2K is a global index that measures SLE disease activity. It includes 24 items for the 9 organs/systems. Scores range from 0 to 105; a score of 6 is considered clinically important. The index measures disease activity within the last 10 days. Higher scores mean worse outcome. Negative percent change means reduced disease activity. | Intension-To-Treat Set included 36 subjects (12 of each Group). At week 14, 1 subject in Placebo Group had no end of Treatment result; at week 28, 1 subject of 50 mg and 2 subjects of Placebo had no results. The efficacy outcome was based on observed cases. | Posted | Mean | Standard Deviation | percentage of change | Baseline to week 14 and at week 28 |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| 2 |
| 12 |
| EG001 | BT063 100 mg | 100 mg BT063 administered by intravenous (IV) infusion 8 times BT063: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12) | 0 | 12 | 1 | 12 | 6 | 12 |
| EG002 | Placebo | Placebo administered by IV infusion 8 times Placebo: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12) | 0 | 12 | 0 | 12 | 6 | 12 |
|
| Bronchopneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment | moderate; not related; recovered |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment | moderate; not related; recovered |
|
| FATIGUE | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
|
The Investigator shall not publish, present, or use any Study data or results arising out of the performance of the Study for their own instruction, research, or publication purposes without the prior express written consent of Sponsor, which consent may be withheld at Sponsor's discretion.
| 50% improvement in swollen joints at week 28 |
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| 50% improvement in tender joints at week 14 |
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| 50% improvement in tender joints at week 28 |
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| 50% improvement in CLASI Activity score at week 28 |
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| Percent changes in SLEDAI-2K scores at week 28 |
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