Purpura, Thrombocytopenic, IdiopathicPhase 1NCT03275454
A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP)
A Phase 1 study testing BIVV009 6.5 grams and BIVV009 7.5 grams in people with Purpura, Thrombocytopenic, Idiopathic, run by Bioverativ, a Sanofi company at 5 sites in 3 countries.
Trial summary
The purpose of this study is to explore the safety, preliminary clinical benefit, and activity of BIVV009 in patients with chronic immune thrombocytopenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Purpura, Thrombocytopenic, Idiopathic
- What is being tested?
- BIVV009 6.5 grams and BIVV009 7.5 grams
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 14 Aug 2017to 16 Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part A:
- Chronic immune thrombocytopenia (ITP) (ITP lasting for greater than or equal to ([>=] 12 months) as defined in the protocol
- Normal prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT)
- No history of a coagulation disorder
- Hemoglobin level greater than (>) 10 gram per deciliter (g/dL) (following blood transfusion is acceptable) and normal white blood cell (WBC) and neutrophil counts (elevated WBC/absolute neutrophil count [ANC] attributed to steroid treatment is acceptable)
- Eastern Cooperative Oncology Group (ECOG) performance status grade less than or equal to (<=) 2
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- Documented vaccinations against encapsulated bacterial pathogens (Neisseria meningitis, including serogroup B meningococcus [where available], Haemophilus influenzae, and Streptococcus pneumoniae) within 5 years of enrollment
- Adequate intravenous (IV) access
- Part B:
- Able to comprehend and to give informed consent for Part B
- History of ITP and previously treated with at least 1 dose of BIVV009 in Part A
- Evidence of treatment efficacy to BIVV009 as defined by a platelet count > 30*10^9/L on at least 1 occasion OR a doubling of the platelet count from baseline
- Participants who have completed the 21-week Part A treatment period but have not reached the Part A End of Study (EOS) visit must have evidence of ongoing or recurrent thrombocytopenia during the Part A safety follow-up/washout period as demonstrated by a platelet count less than (<) 50*10^9/L or a >= 50 percent (%) decrease in platelet count over < 1 week
Who cannot join
- Part A:
- Clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the participant 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 of enrollment
- History of venous or arterial thrombosis within the preceding year of enrollment
- Use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants within 1 week of enrollment
- Clinical diagnosis of systemic lupus erythematosus (SLE) or other active autoimmune disorders associated with anti-nuclear antibodies (ANAs) including those that are medically controlled, at Screening (other than ITP)
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- Secondary immune thrombocytopenia from any cause including lymphoma, chronic lymphocytic leukemia, and drug-induced thrombocytopenia
- Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C virus antibody) prior to or at Screening
- Positive human immunodeficiency virus (HIV) test result prior to or at Screening
- Part B:
- Presence of unacceptable side effects or toxicity associated with BIVV009 (including prior hypersensitivity reactions to BIVV009) such that there is an unfavorable risk-benefit assessment for continued treatment with BIVV009 in the opinion of the Investigator and/or Sponsor
- For participants who have completed the 9-week safety follow-up/washout period and final study visit before entry into Part B, a positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C virus antibody) prior to or at Screening. Patients who have undergone hepatitis C antiviral therapy may be allowed if they are documented to be negative for hepatitis C virus ribonucleic acid (RNA) on at least 2 occasions separated by at least 3 months (including 1 RNA test at least 6 months after completion of antiviral therapy) and are also negative for hepatitis C virus RNA at Screening
- Use of prescribed or over-the-counter medications, supplements, vitamins, and/or herbal remedies within 2 weeks before the first dose of BIVV009 in Part B, which in the judgment of the Investigator may adversely affect the participants welfare or the integrity of the study results (excluding hormonal contraception in female participants)
- If previously treated with rituximab, the last dose of rituximab was administered < 12 weeks before the first dose of BIVV009 in Part B
- Clinical diagnosis of systemic lupus erythematosus (SLE) or other active autoimmune disorders associated with anti-nuclear antibodies (ANA), including those that are medically controlled, at Screening (other than ITP). Positive ANAs at screening that are not associated with an autoimmune disorder (other than ITP) may be allowed if present for >= 28 days without associated clinically relevant symptoms
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Massachusetts General Hospital - Cancer Center
Boston, Massachusetts, 02144
Georgetown Lombardi Comprehensive Cancer Center
Georgetown, District of Columbia, 20057
University of Pittsburgh Medical Center (UPMC) Hilman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Phase 1 Safety, Tolerability, and Pharmacokinetics & Pharmacodynamics Study of Multiple- Dose BIVV009 in Patients With Chronic Immune Thrombocytopenia (ITP)
The purpose of this study is to explore the safety, preliminary clinical benefit, and activity of BIVV009 in patients with chronic immune thrombocytopenia.
- Conditions
- Purpura, Thrombocytopenic, Idiopathic
- Being tested
- BIVV009 6.5 grams, BIVV009 7.5 grams
- Keywords
- Autoimmune Diseases, Hematologic Diseases, Immune System Diseases, Blood Platelet Disorders
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Autoimmune Diseases, Hematologic Diseases, Immune System Diseases, Blood Platelet Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIVV009 6.5 gramsDrug
Participants who weigh less than 75 kilogram (kg) will receive fixed doses of 6.5 grams of BIVV009.
BIVV009 7.5 gramsDrug
Participants who weigh 75 kg or more will receive fixed doses of 7.5 grams of BIVV009.
| Study group | Role | What they receive |
|---|---|---|
| BIVV009 | Experimental | Participants who weigh less than 75 kilogram (kg) will receive fixed doses of 6.5 grams of BIVV009 intravenous (IV) infusion and participants who weigh 75 kg or more will receive fixed doses of 7.5 grams of BIVV009 every 2 weeks for approximately 21 weeks in Part A (based on time to complete 11 doses of study drug). There will be a 9-week safety follow-up/washout period after administration of the last dose of study drug in Part A. Participants who have been shown to benefit from BIVV009 treatment during Part A, will receive BIVV009 (based on weight) biweekly for up to 52 weeks of BIVV009 after Last Patient In (LPI) in part B. Receives: Drug: BIVV009 6.5 grams; Drug: BIVV009 7.5 grams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A serious adverse event (SAE) is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: Up to 97 weeks
Number of Participants With Premature Study Terminations
Number of participants with premature study terminations will be assessed.
Measured: Approximately 97 weeks
Number of Participants With Clinical Laboratory Abnormalities
Clinical laboratory abnormalities including one or more specific target-organs for toxicity of BIVV009, abnormalities in D-dimer, thrombin-anti-thrombin assay, and Systemic Lupus Erythematosus (SLE) panel.
Measured: Approximately 97 weeks
Secondary outcomes (30)
Part A: Change From Baseline in Peripheral Blood Platelet Count at Part A End of Treatment (A-EOT)
Change from baseline in peripheral blood platelet count at A-EOT will be assessed.
Measured: Baseline and A-EOT (Day 147)
Part A: Change From Baseline in Peripheral Blood Platelet Count during BIVV009 Treatment
Change from baseline in peripheral blood platelet count during BIVV009 treatment will be assessed.
Measured: Baseline up to Day 147
Part A: Number of Participants who are independent from using combination Immune Thrombocytopenia (ITP) therapy during A-EOT but receive combination ITP therapy after A-EOT
Number of participants who are independent from using combination ITP therapy during A-EOT but receive combination ITP therapy after A-EOT will be assessed.
Measured: Day 147 (A-EOT) up to Day 196 (EOS)
Part A: Number of Participants who Achieve Complete Response Through A-EOT
Complete response (CR) is defined as a platelet count greater than or equal to (>=) 100*10^9/liter (L) measured on 2 occasions at least 7 days apart and the absence of bleeding on and through these two visits and the lack of combination ITP therapy on and through these two visits.
Measured: Up to Day 147
Part A: Number of Participants who Achieve Response Through A-EOT
Response or Better: Response (R) is defined as a platelet count >= 30*10^9/L and a greater than 2-fold increase from baseline measured on 2 occasions at least 7 days apart and the absence of bleeding on and through these two visits and the lack of combination ITP therapy on and through these two visits; and CR: A platelet count >=100*10^9/L measured on 2 occasions at least 7 days apart and the absence of bleeding on and through these two visits and the lack of combination ITP therapy on and through these two visits.
Measured: Up to Day 147
Part A: Duration of Complete Response per Each CR
Duration of CR is defined as the number of consecutive days in which a patient's peripheral blood platelet count is >= 100*10^9/L and the absence of bleeding, and the lack of platelet transfusions or other ITP therapy.
Measured: Up to Day 196
Part A: Duration of Response per Each Response
Duration of response is defined as the number of consecutive days in which a patient's peripheral blood platelet count is >= 30*10^9/L and the absence of bleeding, and the lack of platelet transfusions or other ITP therapy.
Measured: Up to Day 196
Part A: Time to First Platelet Response
Time to first platelet response is defined as greater than or equal to 30*10^9/L, 50*10^9/L, 100*10^9/L (confirmed by a consecutive platelet response at least 7 days apart).
Measured: Up to Day 196
Part A: Number of Participants who Report Loss of Response Among Those who Achieve Response
Number of participants who report loss of response among those who achieve response will be reported. For a participant with a response (R), the loss of the response is defined as a platelet count < 30*10^9/L measured on 2 consecutive occasions at least 1 day apart, or a less than 2-fold increase in platelet count from baseline measured on 2 consecutive occasions at least 1 day apart, or the presence of bleeding, or use of the combination ITP therapy.
Measured: Up to Day 196
Part A: Number of Participants who Report Loss of Complete Response Among Those who Achieve Complete Response
Number of participants who report loss of complete response among those who achieve complete response will be reported. For a participant with a complete response (CR), loss of complete response is defined as a platelet count less than (<) 100*10^9/L measured on 2 consecutive occasions more than 1 day apart and/or the presence of bleeding or use of the combination ITP therapy.
Measured: Up to Day 196
Part B: Change From Baseline in Peripheral Blood Platelet Count to B-EOT
Change from baseline (Part B) in peripheral blood platelet count to B-EOT will be assessed.
Measured: Baseline up to 52 weeks
Part B: Number of Participants who Achieve CR and the Lack of Platelet Transfusions or Other ITP Therapy During Treatment Period
Number of participants who achieve CR and the lack of platelet transfusions or other ITP therapy during Part B treatment period will be reported. Complete response (CR): A platelet count >= 100*10^9/L measured on 2 occasions at least 7 days apart and the absence of bleeding on and through these two visits and the lack of combination ITP therapy on and through these two visits.
Measured: Up to 52 weeks
Part B: Number of Participants who Achieve Response Through Part B End of Treatment (B-EOT)
Number of participants who achieve response through B-EOT will be reported.
Measured: Up to 52 weeks
Part B: Duration of Complete Response per Each CR
Duration of CR is defined as the number of consecutive days in which a participant's peripheral blood platelet count is >= 100*10^9/L and the absence of bleeding, and the lack of platelet transfusions or other ITP therapy.
Measured: Up to 52 weeks
Part B: Duration of Response per each Response
Duration of response is defined as the number of consecutive days in which a participant's peripheral blood platelet count is >= 30*10^9/L and the absence of bleeding, and the lack of platelet transfusions or other ITP therapy.
Measured: Up to 52 weeks
Part B: Number of Participants who achieve a platelet count >= 100*10^9/L on 2 consecutive occasions at least 7 days apart and have the absence of bleeding on and through these two visits and use any combination ITP therapy through B-EOT
Number of participants who achieve a platelet count >= 100*10^9/L on 2 consecutive occasions at least 7 days apart and have the absence of bleeding on and through these two visits and use any combination ITP therapy through B-EOT will be assessed.
Measured: Up to 52 weeks
Part B: Number of Participants who achieve a platelet count >=30*10^9/L, a >2-fold increase from baseline measured on 2 consecutive occasions at least 7 days apart, have absence of bleeding on and through these two visits, use any combination ITP therapy
Number of participants who achieve a platelet count >= 30*10^9/L and a greater than (>) 2-fold increase from baseline measured on 2 consecutive occasions at least 7 days apart and have the absence of bleeding on and through these two visits and use any combination ITP therapy through B-EOT will be assessed.
Measured: Up to 52 weeks
Part B: Number of Participants who do not Require Other Immune Thrombocytopenia (ITP) Therapy (non-transfusion) During the Part B Treatment Period
Number of Participants who do not require other ITP therapy (non-transfusion) following the last BIVV009 dose will be assessed.
Measured: Up to 52 weeks
Part B: Number of Participants who do not Require Platelet Transfusions During the Part B Treatment Period
Number of Participants who do not require platelet transfusions during the Part B treatment period will be reported.
Measured: Up to 52 weeks
Part B: Number of Participants who Experience any Bleeding Episode, Bleeding by Grade or Serious Bleeding
Number of participants who experience any bleeding episode, bleeding by grade or serious bleeding according to the International Working Group (IWG) Bleeding Assessment Tool (BAT) will be reported.
Measured: Up to 52 weeks
Plasma Concentrations of BIVV009
Plasma concentrations of BIVV009 will be assessed.
Measured: Approximately 97 weeks
Maximum Observed Plasma Concentration (Cmax) of BIVV009
Maximum observed concentration of BIVV009 in plasma will be assessed.
Measured: Approximately 97 weeks
Time to Reach Maximum Observed Plasma Concentration (Tmax) of BIVV009
Time to Reach Maximum Observed Plasma Concentration (Tmax) of BIVV009 will be assessed.
Measured: Approximately 97 weeks
Area Under the Concentration-time Curve (AUC) From Hour 0 to the last quantifiable time point (AUC [0-t]) of BIVV009
AUC (0-t) is the area under the Concentration-time curve (AUC) from hour 0 to the last quantifiable time point of BIVV009.
Measured: Approximately 97 weeks
Number of Participants With Anti-drug antibodies (ADAs) Against BIVV009
Blood samples will be collected to determine number of participants with anti-drug antibodies (ADAs) against BIVV009.
Measured: Up to 97 weeks
Complement System Classical Pathway Levels as Measured by WIESLAB Assay
Inhibition by BIVV009 of the complement system classical pathway measured by the WIESLAB assay.
Measured: Up to 97 weeks
Total Complement (CH50) Levels
Complement CH50 is a blood test that helps us determine whether protein abnormalities and deficiencies in the complement system are responsible for any increase in autoimmune activity. It will be assessed using complement assays.
Measured: Up to 97 weeks
Total Complement Factor C4 Levels
Total C4 Levels will be assessed in plasma using complement assays.
Measured: Up to 97 weeks
C1 Complex Components: C1q
C1q Levels will be assessed in plasma using complement assays.
Measured: Up to 97 weeks
Thrombopoietin Level
Thrombopoietin level will be assessed in plasma using complement assays.
Measured: Up to 97 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start14 Aug 2017
- Primary completion16 Feb 2021
- Study completion16 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Purpura, Thrombocytopenic, IdiopathicStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioverativ, a Sanofi company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275454
- Sponsor's protocol ID
- TDR16218
- Other IDs
- BIVV009-201
- Status last verified
- Apr 2022
- First submitted
- 5 Sep 2017
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- 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
Broome CM, Roth A, Kuter DJ, Scully M, Smith R, Wang J, Reuter C, Hobbs W, Daak A. Safety and efficacy of classical complement pathway inhibition with sutimlimab in chronic immune thrombocytopenia. Blood Adv. 2023 Mar 28;7(6):987-996. doi: 10.1182/bloodadvances.2021006864.
PubMed 35973190
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Safety, Tolerability, and Pharmacokinetics & Pharmacodynamics Study of Multiple- Dose BIVV009 in Patients With Chronic Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT03275454
- Acronym / sponsor ID
- TDR16218
- Conditions
- Purpura, Thrombocytopenic, Idiopathic
- Keywords
- Autoimmune Diseases, Hematologic Diseases, Immune System Diseases, Blood Platelet Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bioverativ, a Sanofi companyIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 16 Feb 2021 (actual)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 7 Sep 2017 (actual)
- 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.
The purpose of this study is to explore the safety, preliminary clinical benefit, and activity of BIVV009 in patients with chronic immune thrombocytopenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIVV009 | Experimental | Drug: BIVV009 6.5 grams, Drug: BIVV009 7.5 gramsParticipants who weigh less than 75 kilogram (kg) will receive fixed doses of 6.5 grams of BIVV009 intravenous (IV) infusion and participants who weigh 75 kg or more will receive fixed doses of 7.5 grams of BIVV009 every 2 weeks for approximately 21 weeks in Part A (based on time to complete 11 doses of study drug). There will be a 9-week safety follow-up/washout period after administration of the last dose of study drug in Part A. Participants who have been shown to benefit from BIVV009 treatment during Part A, will receive BIVV009 (based on weight) biweekly for up to 52 weeks of BIVV009 after Last Patient In (LPI) in part B. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Chronic immune thrombocytopenia (ITP) (ITP lasting for greater than or equal to ([>=] 12 months) as defined in the protocol
- Normal prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT)
- No history of a coagulation disorder
- Hemoglobin level greater than (>) 10 gram per deciliter (g/dL) (following blood transfusion is acceptable) and normal white blood cell (WBC) and neutrophil counts (elevated WBC/absolute neutrophil count [ANC] attributed to steroid treatment is acceptable)
- Eastern Cooperative Oncology Group (ECOG) performance status grade less than or equal to (<=) 2
Key exclusion criteria (15 listed)
- Clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the participant 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 of enrollment
- History of venous or arterial thrombosis within the preceding year of enrollment
- Use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants within 1 week of enrollment
- Clinical diagnosis of systemic lupus erythematosus (SLE) or other active autoimmune disorders associated with anti-nuclear antibodies (ANAs) including those that are medically controlled, at Screening (other than ITP)
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 |
|---|---|---|
| BIVV009 6.5 gramsParticipants who weigh less than 75 kilogram (kg) will receive fixed doses of 6.5 grams of BIVV009. | Drug | BIVV009 |
| BIVV009 7.5 gramsParticipants who weigh 75 kg or more will receive fixed doses of 7.5 grams of BIVV009. | Drug | BIVV009 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 97 weeks
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A serious adverse event (SAE) is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Number of Participants With Premature Study Terminations
Time frame: Approximately 97 weeks
Number of participants with premature study terminations will be assessed.
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Approximately 97 weeks
Clinical laboratory abnormalities including one or more specific target-organs for toxicity of BIVV009, abnormalities in D-dimer, thrombin-anti-thrombin assay, and Systemic Lupus Erythematosus (SLE) panel.
30 secondary outcomes
Part A: Change From Baseline in Peripheral Blood Platelet Count at Part A End of Treatment (A-EOT)
Time frame: Baseline and A-EOT (Day 147)
Part A: Change From Baseline in Peripheral Blood Platelet Count during BIVV009 Treatment
Time frame: Baseline up to Day 147
Part A: Number of Participants who are independent from using combination Immune Thrombocytopenia (ITP) therapy during A-EOT but receive combination ITP therapy after A-EOT
Time frame: Day 147 (A-EOT) up to Day 196 (EOS)
Part A: Number of Participants who Achieve Complete Response Through A-EOT
Time frame: Up to Day 147
Part A: Number of Participants who Achieve Response Through A-EOT
Time frame: Up to Day 147
Part A: Duration of Complete Response per Each CR
Time frame: Up to Day 196
Part A: Duration of Response per Each Response
Time frame: Up to Day 196
Part A: Time to First Platelet Response
Time frame: Up to Day 196
Part A: Number of Participants who Report Loss of Response Among Those who Achieve Response
Time frame: Up to Day 196
Part A: Number of Participants who Report Loss of Complete Response Among Those who Achieve Complete Response
Time frame: Up to Day 196
Part B: Change From Baseline in Peripheral Blood Platelet Count to B-EOT
Time frame: Baseline up to 52 weeks
Part B: Number of Participants who Achieve CR and the Lack of Platelet Transfusions or Other ITP Therapy During Treatment Period
Time frame: Up to 52 weeks
Part B: Number of Participants who Achieve Response Through Part B End of Treatment (B-EOT)
Time frame: Up to 52 weeks
Part B: Duration of Complete Response per Each CR
Time frame: Up to 52 weeks
Part B: Duration of Response per each Response
Time frame: Up to 52 weeks
Part B: Number of Participants who achieve a platelet count >= 100*10^9/L on 2 consecutive occasions at least 7 days apart and have the absence of bleeding on and through these two visits and use any combination ITP therapy through B-EOT
Time frame: Up to 52 weeks
Part B: Number of Participants who achieve a platelet count >=30*10^9/L, a >2-fold increase from baseline measured on 2 consecutive occasions at least 7 days apart, have absence of bleeding on and through these two visits, use any combination ITP therapy
Time frame: Up to 52 weeks
Part B: Number of Participants who do not Require Other Immune Thrombocytopenia (ITP) Therapy (non-transfusion) During the Part B Treatment Period
Time frame: Up to 52 weeks
Part B: Number of Participants who do not Require Platelet Transfusions During the Part B Treatment Period
Time frame: Up to 52 weeks
Part B: Number of Participants who Experience any Bleeding Episode, Bleeding by Grade or Serious Bleeding
Time frame: Up to 52 weeks
Plasma Concentrations of BIVV009
Time frame: Approximately 97 weeks
Maximum Observed Plasma Concentration (Cmax) of BIVV009
Time frame: Approximately 97 weeks
Time to Reach Maximum Observed Plasma Concentration (Tmax) of BIVV009
Time frame: Approximately 97 weeks
Area Under the Concentration-time Curve (AUC) From Hour 0 to the last quantifiable time point (AUC [0-t]) of BIVV009
Time frame: Approximately 97 weeks
Number of Participants With Anti-drug antibodies (ADAs) Against BIVV009
Time frame: Up to 97 weeks
Complement System Classical Pathway Levels as Measured by WIESLAB Assay
Time frame: Up to 97 weeks
Total Complement (CH50) Levels
Time frame: Up to 97 weeks
Total Complement Factor C4 Levels
Time frame: Up to 97 weeks
C1 Complex Components: C1q
Time frame: Up to 97 weeks
Thrombopoietin Level
Time frame: Up to 97 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 18 May 2023.
- Results publication: PubMed 35973190Broome CM, Roth A, Kuter DJ, Scully M, Smith R, Wang J, Reuter C, Hobbs W, Daak A. Safety and efficacy of classical complement pathway inhibition with sutimlimab in chronic immune thrombocytopenia. Blood Adv. 2023 Mar 28;7(6):987-996. doi: 10.1182/bloodadvances.2021006864.
- 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
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIVV009 6.5 grams and BIVV009 7.5 grams in people with Purpura, Thrombocytopenic, Idiopathic, run by Bioverativ, a Sanofi company at 5 sites in 3 countries.
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 13 inclusion and 15 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 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Germany, United Kingdom. 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. 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?
Incidence of Treatment-Emergent Adverse Events (time frame: Up to 97 weeks). The study lists 3 primary outcomes in all. 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 NCT03275454, which also lists 1 linked publication.
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 18 May 2023.