To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA).
Study Details
Study Description
Brief Summary
This is a Phase 2 non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 in patients with Warm Autoimmune Hemolytic Anemia.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
This is a Phase 2, non-randomized, sequential, open-label study to investigate the safety, tolerability, PK, PD, and efficacy of RVT-1401 (680 mg/weekly and 340 mg/weekly) in patients with Warm Autoimmune Hemolytic Anemia that is worsening or refractory in spite of therapy with steroids and or immunosuppressants or worsening with steroid or immunosuppressant taper. Two cohorts of participants will be enrolled in a non-randomized sequential approach. Participants will be enrolled into Cohort 1 (680 mg/weekly) first followed by Cohort 2 (340 mg/weekly).
Following the initial dose at the Baseline Visit (Week 1, Day 1), study visits will occur weekly throughout the treatment period. Following the final dose at Week 12, visits will occur weekly through Week 14 and then at Week 16 and Week 20. Safety, PK, PD, and clinical assessments will be collected throughout the study.
Each participant will participate in the study for up to approximately 24 weeks: up to a 4-week screening period, a 12-week treatment period, and an 8-week follow up period.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cohort 1 Dosing Regimen A - 680 mg weekly for 12 weeks via once weekly subcutaneous (SC) injections |
Drug: RVT-1401 680 mg/weekly
Non-randomized subjects will receive subcutaneous injection of 680 mg weekly for 12 weeks of RVT-1401
|
Experimental: Cohort 2 Dosing Regimen B - 340 mg weekly for 12 weeks via once weekly subcutaneous (SC) injections |
Drug: RVT-1401 340 mg/weekly
Non-randomized subjects will receive subcutaneous injection of 340 mg weekly for 12 weeks of RVT-1401
|
Outcome Measures
Primary Outcome Measures
- Number of Responders at Week 13 [Week 13]
Responders were defined as the participants with level of hemoglobin (Hb) >=10 grams per deciliter (g/dL) with at least a >=2 g/dL increase from Baseline without rescue therapy or blood transfusions in the previous two weeks.
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Serious AE (SAE), Treatment-related Adverse Event (AE), and Death [Up to Week 20]
AEs were defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Clinically significant changes determined by the Investigator such as vital signs, Electrocardiograms (ECGs), and clinical laboratory values were also reported as AEs. TEAEs were defined as AEs that either started on or after the date of the first dose of study drug. SAEs were defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event that may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the other outcomes listed in the definition.
Secondary Outcome Measures
- Time to Response [Up to Week 13]
The time to response was defined as the amount of time to achieve response (Hb levels >=10 g/dL with at least a >=2 g/dL increase from Baseline without rescue therapy or blood transfusions in the previous 2 weeks).
- Time to Achieving Hb Levels in the Normal Range [Up to Week 13]
Time to achieving Hb levels in the normal range was assessed.
- Number of Participants With Change in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score [Up to Week 13]
The FACIT-F scale was a validated scale which measured the physical, emotional and social implications of fatigue, one of the key clinical manifestations of warm autoimmune hemolytic anemia. Scores ranged from 0-52, a higher score indicated a higher quality of life. A score of less than 30 indicated severe fatigue. The scale took approximately 5-10 minutes to complete.
- Number of Participants With Change in Medical Research Council (MRC) Breathlessness Scale [Up to Week 13]
The MRC Breathlessness scale is a questionnaire that consisted of 5 statements about perceived Breathlessness and the focus of the scale was to quantify the disability associated with breathlessness. Score ranged from Grade 0 (limited to no disability) to Grade 4 (severe disability); higher score indicated severe disability.
- Number of Participants With Change in Euro Quality-5 Dimension-3 Level (EQ-5D-3L) Score [Up to Week 20]
The EQ-5D-3L is a validated measurement of health-related quality of life. The scale consists of 2 components, the EQ-5D descriptive system and the EQ visual analogue scale (VAS). The descriptive system evaluates mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1=no problems, 2=some problems, and 3=extreme problems; a lower score indicated better quality of life. The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' (100) and 'Worst imaginable health state' (0).
- Concentration of RVT-1401 Pre-dose [Pre-dose, Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 13 post-dose]
Blood samples were planned to be collected at indicated time points to measure the concentration of RVT-1401 pre-dose (Ctrough) as an assessment of the pharmacokinetic (PK) RVT-1401.
- Number of Participants With Presence of Anti-RVT 1401 Antibodies [Pre-dose on Weeks 1, 3, 5, 8, 13 and Week 20]
Blood samples were collected at indicated time points to determine presence of anti-RVT 1401 antibodies. Participants with presence of anti-RVT 1401 antibodies is reported
- Number of Participants With Change in Levels of Total Immunoglobulin (Ig)G and IgG Subclasses (1-4) [Up to Week 20]
Blood samples were collected at indicated time points for pharmacodynamic (PD) analysis of serum total IgG and IgG subclasses (1-4) concentrations. Participants with changes in levels of Total IgG and IgG Subclasses (1-4) is reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female ≥ 18 years of age.
-
Diagnosis of primary or secondary WAIHA as documented by a positive direct antiglobulin test (DAT) specific for anti-IgG alone or anti-IgG plus C3d.
-
Secondary WAIHA may only include Stage 0 chronic lymphocytic leukemia (CLL) in which separate treatment is not indicated, nor anticipated to require active management for the duration of the study.
-
Have failed or not tolerated at least one prior WAIHA treatment regimen as per local standards (e.g., steroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil (MMF), danazol, or vincristine). Failure is defined as worsening or refractory disease despite steroids and or immunosuppressants.
-
Participants with splenectomy ≥3 months from Day 1 who are up to date on vaccinations (based on age and local guidance) are allowed.
-
At Screening and Baseline, subject's hemoglobin level must be <10 g/dL and the subject must have documented symptoms related to anemia (e.g., weakness, dizziness, fatigue, shortness of breath, chest pain).
-
Subject's concurrent treatment for WAIHA may consist only of steroids (stable dose for at least two weeks prior to Day 1), immunosuppressant therapy (azathioprine, MMF, or cyclosporine) that has been at a stable dose for at least four weeks prior to Day 1, or erythropoietin (stable dose for at least 6 weeks prior to Day 1). [Note: starting doses of WAIHA therapy must be maintained throughout the study except in the case of a rescue medication as per local standards for safety. Steroid taper down to 10 mg/day will be allowed for participants who achieve response for at least 2 weeks.]
-
A female participant is eligible to participate if she is of:
-
Non-childbearing potential defined as pre-menopausal females with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries) or hysterectomy; hysteroscopic sterilization, or postmenopausal defined as 12 months of spontaneous amenorrhea.
-
Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or Principal Investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female participants must agree to use contraception until 90 days after the last dose of study treatment.
-
Male participants must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study treatment until 90 days after the last dose of study treatment.
-
Willing and capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Other, more specific inclusion criteria are defined in the protocol.
Exclusion Criteria:
-
Participants with other types of AIHA (e.g., cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria).
-
Participants requiring more than 2 units of RBC per week in the 2 weeks prior to Screening and Baseline.
-
Use of rituximab, any monoclonal antibody for immunomodulation, or proteasome inhibitor, within the past 3 months prior to Screening.
-
Immunoglobulins given by SC, IV (IVIG), or intramuscular route, or plasmapheresis/plasma exchange (PE) within 60 days before Screening.
-
Total IgG level <6 g/L (at Screening).
-
Absolute neutrophil count <1000 cells/mm3(at Screening).
Other, more specific exclusion criteria are defined in the protocol.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Iowa Hospitals & Clinics | Iowa City | Iowa | United States | 52242 |
2 | Norton Cancer Institute | Louisville | Kentucky | United States | 40202 |
3 | Massachusetts General Hospital Cancer Center - Hematology/Oncology | Boston | Massachusetts | United States | 02114 |
4 | University of Michigan - Internal Medicine Division of Hematology/Oncology | Ann Arbor | Michigan | United States | 48109 |
5 | Leo W. Jenkins Cancer Center | Greenville | North Carolina | United States | 27834 |
6 | Ha'Emek Medical Center | Afula | Israel | 1834111 | |
7 | Carmal MC | Haifa | Israel | 3436212 | |
8 | Meir Medical Center | Kfar Saba | Israel | 4428164 | |
9 | Gachon University Gil Medical Center | Incheon | Korea, Republic of | 21565 | |
10 | Seoul National University Bundang Hospital | Seongnam | Korea, Republic of | 13620 | |
11 | Korea University Anam Hospital | Seoul | Korea, Republic of | 02841 | |
12 | Seoul National University Hospital - Department of Internal Medicine | Seoul | Korea, Republic of | 03080 | |
13 | Asan Medical Center | Seoul | Korea, Republic of | 05-505 | |
14 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
15 | Hospital Universitario Quirónsalud Madrid | Barcelona | Spain | 08035 | |
16 | Hospital Universitario Quirón | Madrid | Spain | 28223 | |
17 | Faculty of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital | Bangkok | Thailand | 10330 | |
18 | Faculty of Medicine, Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | Thailand | 50200 | |
19 | Faculty of Medicine, Prince of Songkla University,Songklanagarind Hospital | Hat Yai | Thailand | 90110 | |
20 | Faculty of Medicine, Khon Kaen University, Srinagarind Hospital | Khon Kaen | Thailand | 40002 | |
21 | Royal Cornwall Hospital | Truro | United Kingdom | TR1 3LJ |
Sponsors and Collaborators
- Immunovant Sciences GmbH
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- RVT-1401-2003
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | A total of 11 participants were screened, of which 5 participants were enrolled and randomized into the study. The study was terminated early prior to completion of dosing all participants in Cohort 1 and prior to initiating Cohort 2, as efficacy and safety conclusions could not be drawn and Pharmacokinetics/Pharmacodynamics (PK/PD) data were limited, due to the small number of participants (n=5) enrolled in the study. |
Arm/Group Title | Cohort 1: RVT-1401 680 mg/Week | Cohort 2: RVT-1401 340 mg/Week |
---|---|---|
Arm/Group Description | Participants received RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks. | Participants were planned to receive RVT-1401 340 mg SC injection weekly for 12 weeks. |
Period Title: Overall Study | ||
STARTED | 5 | 0 |
COMPLETED | 2 | 0 |
NOT COMPLETED | 3 | 0 |
Baseline Characteristics
Arm/Group Title | Cohort 1: RVT-1401 680 mg/Week | Cohort 2: RVT-1401 340 mg/Week | Total |
---|---|---|---|
Arm/Group Description | Participants received RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks. | Participants were planned to receive RVT-1401 340 mg SC injection weekly for 12 weeks. | Total of all reporting groups |
Overall Participants | 5 | 0 | 5 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
NaN
|
0
0%
|
Between 18 and 65 years |
4
80%
|
0
NaN
|
4
80%
|
>=65 years |
1
20%
|
0
NaN
|
1
20%
|
Sex: Female, Male (Count of Participants) | |||
Female |
3
60%
|
0
NaN
|
3
60%
|
Male |
2
40%
|
0
NaN
|
2
40%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
0
0%
|
0
NaN
|
0
0%
|
Not Hispanic or Latino |
5
100%
|
0
NaN
|
5
100%
|
Unknown or Not Reported |
0
0%
|
0
NaN
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
NaN
|
0
0%
|
Asian |
4
80%
|
0
NaN
|
4
80%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
NaN
|
0
0%
|
Black or African American |
0
0%
|
0
NaN
|
0
0%
|
White |
1
20%
|
0
NaN
|
1
20%
|
More than one race |
0
0%
|
0
NaN
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
NaN
|
0
0%
|
Outcome Measures
Title | Number of Responders at Week 13 |
---|---|
Description | Responders were defined as the participants with level of hemoglobin (Hb) >=10 grams per deciliter (g/dL) with at least a >=2 g/dL increase from Baseline without rescue therapy or blood transfusions in the previous two weeks. |
Time Frame | Week 13 |
Outcome Measure Data
Analysis Population Description |
---|
Safety population: All participants who enrolled in the study and received at least 1 dose of study treatment. Data was not collected for Cohort 2 due to early termination of the trial. |
Arm/Group Title | Cohort 1: RVT-1401 680 mg/Week | Cohort 2: RVT-1401 340 mg/Week |
---|---|---|
Arm/Group Description | Participants received RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks. | Participants were planned to receive RVT-1401 340 mg SC injection weekly for 12 weeks. |
Measure Participants | 5 | 0 |
Count of Participants [Participants] |
1
20%
|
Title | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Serious AE (SAE), Treatment-related Adverse Event (AE), and Death |
---|---|
Description | AEs were defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Clinically significant changes determined by the Investigator such as vital signs, Electrocardiograms (ECGs), and clinical laboratory values were also reported as AEs. TEAEs were defined as AEs that either started on or after the date of the first dose of study drug. SAEs were defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event that may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the other outcomes listed in the definition. |
Time Frame | Up to Week 20 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Data was not collected for Cohort 2 due to early termination of the trial. |
Arm/Group Title | Cohort 1: RVT-1401 680 mg/Week | Cohort 2: RVT-1401 340 mg/Week |
---|---|---|
Arm/Group Description | Participants received RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks. | Participants were planned to receive RVT-1401 340 mg SC injection weekly for 12 weeks. |
Measure Participants | 5 | 0 |
TEAEs |
5
100%
|
|
SAEs |
1
20%
|
|
Treatment-related AEs |
4
80%
|
|
Deaths |
0
0%
|
Title | Time to Response |
---|---|
Description | The time to response was defined as the amount of time to achieve response (Hb levels >=10 g/dL with at least a >=2 g/dL increase from Baseline without rescue therapy or blood transfusions in the previous 2 weeks). |
Time Frame | Up to Week 13 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only those participants with data available at the specified time points were analyzed. Data was not collected for Cohort 2 due to early termination of the trial. |
Arm/Group Title | Cohort 1: RVT-1401 680 mg/Week | Cohort 2: RVT-1401 340 mg/Week |
---|---|---|
Arm/Group Description | Participants received RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks. | Participants were planned to receive RVT-1401 340 mg SC injection weekly for 12 weeks. |
Measure Participants | 1 | 0 |
Number [Weeks] |
3
|
Title | Time to Achieving Hb Levels in the Normal Range |
---|---|
Description | Time to achieving Hb levels in the normal range was assessed. |
Time Frame | Up to Week 13 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only those participants with data available at the specified time points were analyzed. Data was not collected for Cohort 2 due to early termination of the trial. |
Arm/Group Title | Cohort 1: RVT-1401 680 mg/Week | Cohort 2: RVT-1401 340 mg/Week |
---|---|---|
Arm/Group Description | Participants received RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks. | Participants were planned to receive RVT-1401 340 mg SC injection weekly for 12 weeks. |
Measure Participants | 1 | 0 |
Number [Weeks] |
5
|
Title | Number of Participants With Change in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score |
---|---|
Description | The FACIT-F scale was a validated scale which measured the physical, emotional and social implications of fatigue, one of the key clinical manifestations of warm autoimmune hemolytic anemia. Scores ranged from 0-52, a higher score indicated a higher quality of life. A score of less than 30 indicated severe fatigue. The scale took approximately 5-10 minutes to complete. |
Time Frame | Up to Week 13 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Data was not collected for Cohort 2 due to early termination of the trial. |
Arm/Group Title | Cohort 1: RVT-1401 680 mg/Week | Cohort 2: RVT-1401 340 mg/Week |
---|---|---|
Arm/Group Description | Participants received RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks. | Participants were planned to receive RVT-1401 340 mg SC injection weekly for 12 weeks. |
Measure Participants | 5 | 0 |
Count of Participants [Participants] |
3
60%
|
Title | Number of Participants With Change in Medical Research Council (MRC) Breathlessness Scale |
---|---|
Description | The MRC Breathlessness scale is a questionnaire that consisted of 5 statements about perceived Breathlessness and the focus of the scale was to quantify the disability associated with breathlessness. Score ranged from Grade 0 (limited to no disability) to Grade 4 (severe disability); higher score indicated severe disability. |
Time Frame | Up to Week 13 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Data was not collected for Cohort 2 due to early termination of the trial. |
Arm/Group Title | Cohort 1: RVT-1401 680 mg/Week | Cohort 2: RVT-1401 340 mg/Week |
---|---|---|
Arm/Group Description | Participants received RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks. | Participants were planned to receive RVT-1401 340 mg SC injection weekly for 12 weeks. |
Measure Participants | 5 | 0 |
Count of Participants [Participants] |
4
80%
|
Title | Number of Participants With Change in Euro Quality-5 Dimension-3 Level (EQ-5D-3L) Score |
---|---|
Description | The EQ-5D-3L is a validated measurement of health-related quality of life. The scale consists of 2 components, the EQ-5D descriptive system and the EQ visual analogue scale (VAS). The descriptive system evaluates mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1=no problems, 2=some problems, and 3=extreme problems; a lower score indicated better quality of life. The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' (100) and 'Worst imaginable health state' (0). |
Time Frame | Up to Week 20 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Data was not collected for Cohort 2 due to early termination of the trial. |
Arm/Group Title | Cohort 1: RVT-1401 680 mg/Week | Cohort 2: RVT-1401 340 mg/Week |
---|---|---|
Arm/Group Description | Participants received RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks. | Participants were planned to receive RVT-1401 340 mg SC injection weekly for 12 weeks. |
Measure Participants | 5 | 0 |
Count of Participants [Participants] |
4
80%
|
Title | Concentration of RVT-1401 Pre-dose |
---|---|
Description | Blood samples were planned to be collected at indicated time points to measure the concentration of RVT-1401 pre-dose (Ctrough) as an assessment of the pharmacokinetic (PK) RVT-1401. |
Time Frame | Pre-dose, Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 13 post-dose |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Data could not be calculated for Cohort 1 due to high proportion of non-quantifiable values (>30 percent [%] of values were imputed). Data was not collected for Cohort 2 due to early termination of the trial. |
Arm/Group Title | Cohort 1: RVT-1401 680 mg/Week | Cohort 2: RVT-1401 340 mg/Week |
---|---|---|
Arm/Group Description | Participants received RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks. | Participants were planned to receive RVT-1401 340 mg SC injection weekly for 12 weeks. |
Measure Participants | 5 | 0 |
Geometric Mean (Geometric Coefficient of Variation) [Milligrams per liter] |
NA
(NA)
|
Title | Number of Participants With Presence of Anti-RVT 1401 Antibodies |
---|---|
Description | Blood samples were collected at indicated time points to determine presence of anti-RVT 1401 antibodies. Participants with presence of anti-RVT 1401 antibodies is reported |
Time Frame | Pre-dose on Weeks 1, 3, 5, 8, 13 and Week 20 |
Outcome Measure Data
Analysis Population Description |
---|
Safety population. Data was not collected for Cohort 2 due to early termination of the trial. |
Arm/Group Title | Cohort 1: RVT-1401 680 mg/Week | Cohort 2: RVT-1401 340 mg/Week |
---|---|---|
Arm/Group Description | Participants received RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks. | Participants were planned to receive RVT-1401 340 mg SC injection weekly for 12 weeks. |
Measure Participants | 5 | 0 |
Count of Participants [Participants] |
0
0%
|
Title | Number of Participants With Change in Levels of Total Immunoglobulin (Ig)G and IgG Subclasses (1-4) |
---|---|
Description | Blood samples were collected at indicated time points for pharmacodynamic (PD) analysis of serum total IgG and IgG subclasses (1-4) concentrations. Participants with changes in levels of Total IgG and IgG Subclasses (1-4) is reported. |
Time Frame | Up to Week 20 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Data was not collected for Cohort 2 due to early termination of the trial. |
Arm/Group Title | Cohort 1: RVT-1401 680 mg/Week | Cohort 2: RVT-1401 340 mg/Week |
---|---|---|
Arm/Group Description | Participants received RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks. | Participants were planned to receive RVT-1401 340 mg SC injection weekly for 12 weeks. |
Measure Participants | 5 | 0 |
Total IgG |
5
100%
|
|
IgG Subclasses (1-4) |
5
100%
|
Adverse Events
Time Frame | All-cause mortality, non-serious TEAEs and SAEs were collected up to Week 20 in Cohort 1. | |||
---|---|---|---|---|
Adverse Event Reporting Description | Safety Population. Only data for Cohort 1 is presented as the study was terminated in Part 1; hence, Cohort 2 was not initiated. | |||
Arm/Group Title | Cohort 1: RVT-1401 680 mg/Week | Cohort 2: RVT-1401 340 mg/Week | ||
Arm/Group Description | Participants received RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks. | Participants were planned to receive RVT-1401 340 mg SC injection weekly for 12 weeks. | ||
All Cause Mortality |
||||
Cohort 1: RVT-1401 680 mg/Week | Cohort 2: RVT-1401 340 mg/Week | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/5 (0%) | 0/0 (NaN) | ||
Serious Adverse Events |
||||
Cohort 1: RVT-1401 680 mg/Week | Cohort 2: RVT-1401 340 mg/Week | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/5 (20%) | 0/0 (NaN) | ||
Blood and lymphatic system disorders | ||||
Immune thrombocytopenia | 1/5 (20%) | 1 | 0/0 (NaN) | 0 |
Other (Not Including Serious) Adverse Events |
||||
Cohort 1: RVT-1401 680 mg/Week | Cohort 2: RVT-1401 340 mg/Week | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 5/5 (100%) | 0/0 (NaN) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 1/5 (20%) | 1 | 0/0 (NaN) | 0 |
Eye disorders | ||||
Cataract | 1/5 (20%) | 1 | 0/0 (NaN) | 0 |
Gastrointestinal disorders | ||||
Nausea | 1/5 (20%) | 1 | 0/0 (NaN) | 0 |
Gingival bleeding | 1/5 (20%) | 1 | 0/0 (NaN) | 0 |
Diarrhoea | 1/5 (20%) | 1 | 0/0 (NaN) | 0 |
General disorders | ||||
Oedema peripheral | 2/5 (40%) | 2 | 0/0 (NaN) | 0 |
Fatigue | 2/5 (40%) | 3 | 0/0 (NaN) | 0 |
Non-cardiac chest pain | 1/5 (20%) | 1 | 0/0 (NaN) | 0 |
Oedema | 1/5 (20%) | 1 | 0/0 (NaN) | 0 |
Infections and infestations | ||||
Rhinitis | 1/5 (20%) | 1 | 0/0 (NaN) | 0 |
Investigations | ||||
Blood cholesterol increased | 1/5 (20%) | 1 | 0/0 (NaN) | 0 |
Metabolism and nutrition disorders | ||||
Hypoalbuminaemia | 3/5 (60%) | 3 | 0/0 (NaN) | 0 |
Hypocalcaemia | 1/5 (20%) | 1 | 0/0 (NaN) | 0 |
Musculoskeletal and connective tissue disorders | ||||
Muscle spasms | 1/5 (20%) | 1 | 0/0 (NaN) | 0 |
Nervous system disorders | ||||
Paraesthesia | 1/5 (20%) | 1 | 0/0 (NaN) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Central Study Contact |
---|---|
Organization | Immunovant, Inc |
Phone | 1-800-797-0414 |
clinicaltrials@immunovant.com |
- RVT-1401-2003