Bullous Pemphigoid (BP)Phase 1BIVV009-01NCT02502903
Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders
A Phase 1 study testing BIV009 in people with Bullous Pemphigoid (BP) and Cold Agglutinin Disease (CAD), run by Bioverativ, a Sanofi company at 1 site in Austria.
Trial summary
Prospective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in NHVs, Part C, a multiple dose (MD) study in patients with a complement-mediated disorder… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD), Warm Autoimmune Hemolytic Anemia (WAIHA)
- What is being tested?
- BIV009
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteAustria
- Study dates
- 13 Jul 2015to 31 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part A/B:
- healthy male or female volunteers, age >= 18 years old
- if female, must be post-menopausal, surgically sterilized, or willing/able to use dual, redundant methods of contraception (e.g., barrier plus oral contraceptives) throughout the study
- previously vaccinated against encapsulated bacterial pathogens (Neisseria meningitidis, Haemophilus influenzae, and Streptococcus pneumoniae) or willing to undergo vaccination
- able to comprehend and to give informed consent
- able to co-operate with the investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures
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- Part C:
- male or female, age >=18 years old
- if female, must be post-menopausal, surgically sterilized, or willing/able to use dual, redundant methods of contraception (e.g., barrier plus oral contraceptives) throughout the study
- previously vaccinated against encapsulated bacterial pathogens (Neisseria meningitidis, Haemophilus influenzae, and Streptococcus pneumoniae) or willing to undergo vaccination
- able to comprehend and to give informed consent
- able to co-operate with the investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures
- History of one of the following complement-mediated disorders:
- bullous pemphigoid (BP)
- cold agglutinin disease (CAD)
- warm autoimmune hemolytic anemia (WAIHA)
- active Antibody-Mediated Rejection (AMR) (acute or chronic) after kidney transplantation
- If CAD, by medical history within the 3 months preceding enrollment, and again at the screening visit:
- Has hemoglobin < 11.0 g/dL
- If AMR:
- is >= 180 days post-kidney transplantation with biopsy-proven late AMR
- has a functioning kidney graft with epidermal growth factor receptor (eGFR) >= 20ml/min/1.73m^2
- has evidence of late, active AMR (acute or chronic) present on renal allograft biopsy:
- molecular signature indicating AMR (molecular AMR score > 0.2)
- morphological and immunohistochemical findings consistent with AMR according to the criteria of the Banff 2013 classification
- morphological findings consistent with an active rejection process: presence of glomerulitis (g score > 0) and / or peritubular capillaritis (ptc score > 0)
- has immunoglobulin G (IgG) type donor-specific antibody (DSA) present in serum (at time of renal allograft biopsy) with MFI > 1000 in single antigen bead assays
- is willing and able to take routine antibiotic prophylaxis with ciprofloxacin
- Part E:
- male or female, age >= 18 years old
- Body weight of >=39 kg at Screening
- history of cold agglutinin disease (CAD) and previously treated with BIVV009 in a BIVV009 clinical trial or named patient program use
- For subjects currently being treated in a BIVV009 named patient program:
- Evidence of treatment response
- For subjects previously treated in a BIVV009 clinical trial or named patient program not currently receiving BIVV009:
- Prior evidence of treatment efficacy and hemoglobin <=10.5 g/dL at Screening or Visit 1 (Day 1) or
- Successful treatment of underlying malignancy or warm autoimmune hemolytic anemia as defined as either:
- Bone marrow biopsy without evidence of overt hematologic malignancy within the prior 3 months
- IgG Direct Antiglobulin Test with <=1+ at Screening Visit
- active hemolysis, with total bilirubin > upper limit of normal (ULN) at the Screening Visit or Visit 1 (Day 1)
- adequate IV access
- negative hepatitis panel (including hepatitis B surface antigen and hepatitis C virus antibody), negative human immunodeficiency virus (HIV) antibody screen and no further clinically significant infection (e.g., pneumonia) at Screening
- if female, must be post-menopausal, surgically sterilised or willing and able to use highly effective methods of birth control throughout the study and for 9 weeks after the last administration of study drug
- able to comprehend and to give informed consent
Who cannot join
- Part A/B:
- clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the subject or compromise the quality of the data derived from his/her participation in this study
- clinically relevant infection of any kind within the preceding month
- clinically relevant abnormal findings on physical examination or clinically relevant laboratory abnormalities
- history of infusion hypersensitivity, allergic or anaphylactic reactions to other therapeutic proteins
- substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the Investigator for the subject to be able to comply fully with study procedures
Show all 37Show fewer
- use of medication during 2 weeks before the start of the study, which in the judgment of the investigator may adversely affect the subject's welfare or the integrity of the study's results (excluding hormonal contraception in female subjects)
- females who are pregnant (positive pregnancy test at screening or during study phase), lactating, or, if having reproductive potential, are considered potentially unreliable with respect to contraceptive practice
- concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to treatment start
- body weight > 98 kg for all subjects in all dose cohorts other than the 100 mg/kg dose cohort of Part A, for which the body weight upper limit is 58 kg
- Part C:
- active acute or chronic viral, bacterial, fungal, or mycobacterial infection, or history of same within preceding month
- autoimmune disorder other than the complement-mediated disorders listed in the Inclusion Criteria
- known malignancy (other than locally limited, previously surgically removed basal cell carcinoma of the skin, lymphoproliferative disorders causally related to the complement-mediated diseases under study, etc.)
- clinically significant hepatobiliary disorder
- history of infusion hypersensitivity, allergic or anaphylactic reactions to other therapeutic proteins
- substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the Investigator for the subject to be able to comply fully with study procedures
- females who are pregnant (positive pregnancy test at screening or during study phase), lactating, or, if having reproductive potential, are considered potentially unreliable with respect to contraceptive practice
- concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to treatment start
- body weight >98 kg
- Solely for kidney transplantation patients with AMR:
- acute graft dysfunction within preceding 1 month
- rejection treatment within preceding 1 month
- morphological or molecular features of T cell-mediated rejection on renal allograft biopsy
- contraindication to ciprofloxacin
- Part E:
- concurrent or prior treatment within the 3 months immediately preceding the Screening Visit (although more remote prior treatment is permitted) with rituximab, azathioprine, or other immune-suppressive therapy (concurrent treatment with corticosteroids is allowed if on stable dose <= 10mg/day prednisone for previous 3 months)
- concurrent or prior treatment within the 6 months immediately preceding the Screening Visit with rituximab combination therapy or other cytotoxic therapy (e.g., fludarabine, bendamustine, cyclophosphamide, ibrutinib or any other cytotoxic drugs)
- For subjects previously treated in a BIVV009 clinical trial not currently receiving BIVV009:
- Ferritin below the lower limit of normal. Concurrent treatment with iron supplementation is permitted if the patient has been on a stable dose for the previous 4 weeks
- Erythropoietin deficiency. Concurrent treatment with erythropoietin is permitted if the patient has been on a stable dose for the previous 6 weeks
- Clinical diagnosis of systemic lupus erythematosus (SLE); or other autoimmune disorders with anti-nuclear antibodies at Screening
- Clinically significant medical history or ongoing illness that is new or progressed since last BIVV009 therapy that would jeopardize the safety of the patient or compromise the quality of the data derived from his/her participation in this study (as determined by the Investigator [or designee] at Screening.
- concurrent plasma exchange therapy
- females who are pregnant (positive pregnancy test at screening or during study phase), lactating, or, if having reproductive potential, are considered potentially unreliable with respect to contraceptive practice
- concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to treatment start or during the entire study
- history of infusion hypersensitivity, or allergic or anaphylactic reactions to BIVV009.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement-mediated Disorders. A Single/Multiple Ascending Dose Phase 1 Study.
Prospective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in NHVs, Part C, a multiple dose (MD) study in patients with a complement-mediated disorder, and Part E, a multiple dose (MD) study in patients with cold agglutinin disease previously treated with BIVV009 within the scope of a BIVV009 clinical trial or named patient program use. Note: For parts A-C as well as at the start of part E, study drug was named TNT009. The study drug name is changed to BIVV009 with final version Final 15.0 of the clinical study protocol.
Read the detailed description
Study TNT009-01 (parts A-C)/ BIVV009 (part E) is a First in Human (FIH) study that uses an Integrated Protocol Design. This Phase 1 study protocol will comprise three sub-parts: a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study in normal male and female human volunteers (NHVs), and a Multiple Dose (MD) study in patients with various complement-mediated disorders not confined to a single disease or therapeutic area. Although these patients represent a population with a diverse set of clinical diagnoses they are united by a common mechanism of disease matched to the mechanism of action of BIV009. Several key safety measures have been incorporated into the design of this study, including use of Sentinel Dosing Groups and an independent Data Safety Monitoring Board (DSMB), as well as an appropriate program of prophylactic vaccinations and clinical biomarker surveillance related to the risks potentially associated with inhibition of the complement system. To allow access of BIVV009 to CAD patients where successful treatment effect has been observed and to allow re-initiation of BIVV009 to previously treated CAD patients, Part E has been added to both continued access to study drug in this subset of study patients, and to further characterize the safety and efficacy to BIVV009.
- Conditions
- Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD), Warm Autoimmune Hemolytic Anemia (WAIHA), End-stage Renal Disease (ESRD)
- Being tested
- BIV009, Placebo
- Medical subject headings
- Pemphigoid, Bullous, Anemia, Hemolytic, Autoimmune, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIV009Drug
PlaceboOther
Also called saline solution 0.9 %
| Study group | Role | What they receive |
|---|---|---|
| Part A | Placebo comparator | Single ascending dose (SAD) in NHVs, 7 cohorts, BIVV009 by IV infusion (0.3,1, 3, 10, 30, 60, or 100 mg/kg) or placebo. Receives: Drug: BIV009; Other: Placebo |
| Part B | Placebo comparator | Multiple ascending dose (MAD) in NHVs, 2 cohorts, 4 weekly IV doses of BIVV009 (30 or 60mg/kg) or placebo. Receives: Drug: BIV009; Other: Placebo |
| Part C | Experimental | Multiple dose (MD) in a single cohort of patients with various complement-mediated disorders. All patients in Part C will receive a single IV test dose of BIVV009 of 10 mg/kg followed by 4 weekly doses of 60 mg/kg. Receives: Drug: BIV009 |
| Part E | Experimental | Multiple dose (MD) in a single cohort of patients with cold agglutinin disease previously treated with BIVV009. All patients in Part E will receive a single IV test dose at week 0, week 1, and every 2 weeks thereafter until EOT. Patients who weigh less than 75 kg will receive fixed doses of 6.5 grams of BIVV009; patients who weigh 75 kg or more will receive fixed doses of 7.5 grams of BIVV009. Dose will be increased from 6.5g to 7.5g dose level if patients current weight is >= 75 kg and there is evidence of hematologic breakthrough OR patients current weight is >= 75 kg and there has been at least a 10 percent increase from the patients last recorded weight. Dose will be decreased from 7.5g to 6.5g for patients whose last weight was >= 75 kg and current weight decreased to < 75 kg. Dose decrease will require Sponsor approval. Receives: Drug: BIV009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug-related Adverse Event profile of BIVV009
Serious and Non-Serious adverse events probably or possibly attributable to BIVV009
Measured: 6 weeks
Secondary outcomes (5)
Pharmacokinetic profile of BIVV009
Tmax, Cmax, Area under curve (AUC) and T1/2
Measured: 6 weeks
Classical pathway complement system activity
inhibition by BIVV009 of the complement system classical pathway measured by the WIESLAB® assay
Measured: 6 weeks
Complement System-Related biomarkers
e.g. CH50
Measured: 6 weeks
Coagulation System-Related biomarkers
e.g. Fibrin D-dimer
Measured: 6 weeks
Disease-Related Biomarkers
e.g. Haptoglobin
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study start13 Jul 2015
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bullous Pemphigoid (BP)Studies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioverativ, a Sanofi company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion Clinical Research GmbH, Assign Data Management and Biostatistics GmbH, ABF Pharmaceutical Services GmbH, Quest Diagnostics-Nichols Insitute, Covance, PPD Laboratories - Virginia, Softworld Inc. - Cambridge, MA
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502903
- Sponsor's protocol ID
- LTS16214
- Other IDs
- BIVV009-01, 2014-003881-26, 2014
- Acronym
- BIVV009-01
- Status last verified
- Apr 2022
- First submitted
- 7 Jul 2015
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Vo A, Ammerman N, Jordan SC. New Therapies for Highly Sensitized Patients on the Waiting List. Kidney360. 2024 Aug 1;5(8):1207-1225. doi: 10.34067/KID.0000000000000509. Epub 2024 Jul 12.
PubMed 38995690Jager U, D'Sa S, Schorgenhofer C, Bartko J, Derhaschnig U, Sillaber C, Jilma-Stohlawetz P, Fillitz M, Schenk T, Patou G, Panicker S, Parry GC, Gilbert JC, Jilma B. Inhibition of complement C1s improves severe hemolytic anemia in cold agglutinin disease: a first-in-human trial. Blood. 2019 Feb 28;133(9):893-901. doi: 10.1182/blood-2018-06-856930. Epub 2018 Dec 17.
PubMed 30559259Eskandary F, Jilma B, Muhlbacher J, Wahrmann M, Regele H, Kozakowski N, Firbas C, Panicker S, Parry GC, Gilbert JC, Halloran PF, Bohmig GA. Anti-C1s monoclonal antibody BIVV009 in late antibody-mediated kidney allograft rejection-results from a first-in-patient phase 1 trial. Am J Transplant. 2018 Apr;18(4):916-926. doi: 10.1111/ajt.14528. Epub 2017 Oct 31.
PubMed 28980446Muhlbacher J, Jilma B, Wahrmann M, Bartko J, Eskandary F, Schorgenhofer C, Schwameis M, Parry GC, Gilbert JC, Panicker S, Bohmig GA. Blockade of HLA Antibody-Triggered Classical Complement Activation in Sera From Subjects Dosed With the Anti-C1s Monoclonal Antibody TNT009-Results from a Randomized First-in-Human Phase 1 Trial. Transplantation. 2017 Oct;101(10):2410-2418. doi: 10.1097/TP.0000000000001804.
PubMed 28926521Derhaschnig U, Gilbert J, Jager U, Bohmig G, Stingl G, Jilma B. Combined integrated protocol/basket trial design for a first-in-human trial. Orphanet J Rare Dis. 2016 Oct 4;11(1):134. doi: 10.1186/s13023-016-0494-z.
PubMed 27716293
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement-mediated Disorders. A Single/Multiple Ascending Dose Phase 1 Study.
- ClinicalTrials.gov ID
- NCT02502903
- Acronym / sponsor ID
- BIVV009-01 / LTS16214
- Conditions
- Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD), Warm Autoimmune Hemolytic Anemia (WAIHA), End-stage Renal Disease (ESRD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Bioverativ, a Sanofi companyIndustry (pharma, biotech, devices)
- Collaborators
- Celerion Clinical Research GmbH, Assign Data Management and Biostatistics GmbH, ABF Pharmaceutical Services GmbH, Quest Diagnostics-Nichols Insitute, Covance, PPD Laboratories - Virginia, Softworld Inc. - Cambridge, MA
- Study start
- 13 Jul 2015 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in NHVs, Part C, a multiple dose (MD) study in patients with a complement-mediated disorder, and Part E, a multiple dose (MD) study in patients with cold agglutinin disease previously treated with BIVV009 within the scope of a BIVV009 clinical trial or named patient program use. Note: For parts A-C as well as at the start of part E, study drug was named TNT009. The study drug name is changed to BIVV009 with final version Final 15.0 of the clinical study protocol.
Detailed description
Study TNT009-01 (parts A-C)/ BIVV009 (part E) is a First in Human (FIH) study that uses an Integrated Protocol Design. This Phase 1 study protocol will comprise three sub-parts: a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study in normal male and female human volunteers (NHVs), and a Multiple Dose (MD) study in patients with various complement-mediated disorders not confined to a single disease or therapeutic area. Although these patients represent a population with a diverse set of clinical diagnoses they are united by a common mechanism of disease matched to the mechanism of action of BIV009. Several key safety measures have been incorporated into the design of this study, including use of Sentinel Dosing Groups and an independent Data Safety Monitoring Board (DSMB), as well as an appropriate program of prophylactic vaccinations and clinical biomarker surveillance related to the risks potentially associated with inhibition of the complement system. To allow access of BIVV009 to CAD patients where successful treatment effect has been observed and to allow re-initiation of BIVV009 to previously treated CAD patients, Part E has been added to both continued access to study drug in this subset of study patients, and to further characterize the safety and efficacy to BIVV009.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A | Placebo comparator | Drug: BIV009, Other: PlaceboSingle ascending dose (SAD) in NHVs, 7 cohorts, BIVV009 by IV infusion (0.3,1, 3, 10, 30, 60, or 100 mg/kg) or placebo. |
| Part B | Placebo comparator | Drug: BIV009, Other: PlaceboMultiple ascending dose (MAD) in NHVs, 2 cohorts, 4 weekly IV doses of BIVV009 (30 or 60mg/kg) or placebo. |
| Part C | Experimental | Drug: BIV009Multiple dose (MD) in a single cohort of patients with various complement-mediated disorders. All patients in Part C will receive a single IV test dose of BIVV009 of 10 mg/kg followed by 4 weekly doses of 60 mg/kg. |
| Part E | Experimental | Drug: BIV009Multiple dose (MD) in a single cohort of patients with cold agglutinin disease previously treated with BIVV009. All patients in Part E will receive a single IV test dose at week 0, week 1, and every 2 weeks thereafter until EOT. Patients who weigh less than 75 kg will receive fixed doses of 6.5 grams of BIVV009; patients who weigh 75 kg or more will receive fixed doses of 7.5 grams of BIVV009. Dose will be increased from 6.5g to 7.5g dose level if patients current weight is >= 75 kg and there is evidence of hematologic breakthrough OR patients current weight is >= 75 kg and there has been at least a 10 percent increase from the patients last recorded weight. Dose will be decreased from 7.5g to 6.5g for patients whose last weight was >= 75 kg and current weight decreased to < 75 kg. Dose decrease will require Sponsor approval. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (44 listed)
- healthy male or female volunteers, age >= 18 years old
- if female, must be post-menopausal, surgically sterilized, or willing/able to use dual, redundant methods of contraception (e.g., barrier plus oral contraceptives) throughout the study
- previously vaccinated against encapsulated bacterial pathogens (Neisseria meningitidis, Haemophilus influenzae, and Streptococcus pneumoniae) or willing to undergo vaccination
- able to comprehend and to give informed consent
- able to co-operate with the investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures
Key exclusion criteria (37 listed)
- clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the subject or compromise the quality of the data derived from his/her participation in this study
- clinically relevant infection of any kind within the preceding month
- clinically relevant abnormal findings on physical examination or clinically relevant laboratory abnormalities
- history of infusion hypersensitivity, allergic or anaphylactic reactions to other therapeutic proteins
- substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the Investigator for the subject to be able to comply fully with study procedures
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 |
|---|---|---|
| BIV009 | Drug | Part A, Part B, Part C, Part E |
| PlaceboAlso: saline solution 0.9 % | Other | Part A, Part B |
Primary outcome
Drug-related Adverse Event profile of BIVV009
Time frame: 6 weeks
Serious and Non-Serious adverse events probably or possibly attributable to BIVV009
5 secondary outcomes
Pharmacokinetic profile of BIVV009
Time frame: 6 weeks
Classical pathway complement system activity
Time frame: 6 weeks
Complement System-Related biomarkers
Time frame: 6 weeks
Coagulation System-Related biomarkers
Time frame: 6 weeks
Disease-Related Biomarkers
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 38995690Vo A, Ammerman N, Jordan SC. New Therapies for Highly Sensitized Patients on the Waiting List. Kidney360. 2024 Aug 1;5(8):1207-1225. doi: 10.34067/KID.0000000000000509. Epub 2024 Jul 12.
- Derived from this study: PubMed 30559259Jager U, D'Sa S, Schorgenhofer C, Bartko J, Derhaschnig U, Sillaber C, Jilma-Stohlawetz P, Fillitz M, Schenk T, Patou G, Panicker S, Parry GC, Gilbert JC, Jilma B. Inhibition of complement C1s improves severe hemolytic anemia in cold agglutinin disease: a first-in-human trial. Blood. 2019 Feb 28;133(9):893-901. doi: 10.1182/blood-2018-06-856930. Epub 2018 Dec 17.
- Derived from this study: PubMed 28980446Eskandary F, Jilma B, Muhlbacher J, Wahrmann M, Regele H, Kozakowski N, Firbas C, Panicker S, Parry GC, Gilbert JC, Halloran PF, Bohmig GA. Anti-C1s monoclonal antibody BIVV009 in late antibody-mediated kidney allograft rejection-results from a first-in-patient phase 1 trial. Am J Transplant. 2018 Apr;18(4):916-926. doi: 10.1111/ajt.14528. Epub 2017 Oct 31.
- Derived from this study: PubMed 28926521Muhlbacher J, Jilma B, Wahrmann M, Bartko J, Eskandary F, Schorgenhofer C, Schwameis M, Parry GC, Gilbert JC, Panicker S, Bohmig GA. Blockade of HLA Antibody-Triggered Classical Complement Activation in Sera From Subjects Dosed With the Anti-C1s Monoclonal Antibody TNT009-Results from a Randomized First-in-Human Phase 1 Trial. Transplantation. 2017 Oct;101(10):2410-2418. doi: 10.1097/TP.0000000000001804.
- Derived from this study: PubMed 27716293Derhaschnig U, Gilbert J, Jager U, Bohmig G, Stingl G, Jilma B. Combined integrated protocol/basket trial design for a first-in-human trial. Orphanet J Rare Dis. 2016 Oct 4;11(1):134. doi: 10.1186/s13023-016-0494-z.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIV009 in people with Bullous Pemphigoid (BP) and Cold Agglutinin Disease (CAD), run by Bioverativ, a Sanofi company at 1 site in Austria.
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 44 inclusion and 37 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: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Drug-related Adverse Event profile of BIVV009 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02502903, which also lists 5 linked publications.
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 25 Apr 2022.