Warm Autoimmune Hemolytic AnemiaPhase 2ASCEND-WAIHANCT04253236
To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA).
A Phase 2 study testing RVT-1401 680 mg/weekly and RVT-1401 340 mg/weekly in people with Warm Autoimmune Hemolytic Anemia, run by Immunovant Sciences GmbH at 21 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Warm Autoimmune Hemolytic Anemia
- What is being tested?
- RVT-1401 680 mg/weekly and RVT-1401 340 mg/weekly
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 21 sitesin 6 countries
- Study dates
- 11 Aug 2020to 1 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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).
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
South Korea6 sites
Gachon University Gil Medical Center
Incheon, 21565
Seoul National University Bundang Hospital
Seongnam, 13620
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital - Department of Internal Medicine
Seoul, 03080
Asan Medical Center
Seoul, 05-505
Samsung Medical Center
Seoul, 06351
United States5 sites
University of Michigan - Internal Medicine Division of Hematology/Oncology
Ann Arbor, Michigan, 48109
Massachusetts General Hospital Cancer Center - Hematology/Oncology
Boston, Massachusetts, 02114
Leo W. Jenkins Cancer Center
Greenville, North Carolina, 27834
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Norton Cancer Institute
Louisville, Kentucky, 40202
Thailand4 sites
Faculty of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital
Bangkok, 10330
Faculty of Medicine, Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
Faculty of Medicine, Prince of Songkla University,Songklanagarind Hospital
Hat Yai, 90110
Faculty of Medicine, Khon Kaen University, Srinagarind Hospital
Khon Kaen, 40002
Israel3 sites
Ha'Emek Medical Center
Afula, 1834111
Carmal MC
Haifa, 3436212
Meir Medical Center
Kfar Saba, 4428164
Spain2 sites
Hospital Universitario Quirónsalud Madrid
Barcelona, 08035
Hospital Universitario Quirón
Madrid, 28223
About this study
Official title: A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients With Warm Autoimmune Hemolytic Anemia
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.
Read the 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.
- Conditions
- Warm Autoimmune Hemolytic Anemia
- Being tested
- RVT-1401 680 mg/weekly, RVT-1401 340 mg/weekly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVT-1401 680 mg/weeklyDrug
Non-randomized subjects will receive subcutaneous injection of 680 mg weekly for 12 weeks of RVT-1401
RVT-1401 340 mg/weeklyDrug
Non-randomized subjects will receive subcutaneous injection of 340 mg weekly for 12 weeks of RVT-1401
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dosing Regimen A - 680 mg weekly for 12 weeks via once weekly subcutaneous (SC) injections Receives: Drug: RVT-1401 680 mg/weekly |
| Cohort 2 | Experimental | Dosing Regimen B - 340 mg weekly for 12 weeks via once weekly subcutaneous (SC) injections Receives: Drug: RVT-1401 340 mg/weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Responders at 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.
Measured: Week 13
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Serious AE (SAE), Treatment-related Adverse Event (AE), and Death
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.
Measured: Up to Week 20
Secondary outcomes (8)
Time to Response
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).
Measured: Up to Week 13
Time to Achieving Hb Levels in the Normal Range
Time to achieving Hb levels in the normal range was assessed.
Measured: Up to Week 13
Number of Participants With Change in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score
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.
Measured: Up to Week 13
Number of Participants With Change in Medical Research Council (MRC) Breathlessness Scale
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.
Measured: Up to Week 13
Number of Participants With Change in Euro Quality-5 Dimension-3 Level (EQ-5D-3L) Score
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).
Measured: Up to Week 20
Concentration of RVT-1401 Pre-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.
Measured: Pre-dose, Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 13 post-dose
Number of Participants With Presence of Anti-RVT 1401 Antibodies
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
Measured: Pre-dose on Weeks 1, 3, 5, 8, 13 and Week 20
Number of Participants With Change in Levels of Total Immunoglobulin (Ig)G and IgG Subclasses (1-4)
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.
Measured: Up to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start11 Aug 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Warm Autoimmune Hemolytic AnemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunovant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253236
- Sponsor's protocol ID
- RVT-1401-2003
- Acronym
- ASCEND-WAIHA
- Status last verified
- Jul 2022
- First submitted
- 21 Jan 2020
- Last updated
- 28 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients With Warm Autoimmune Hemolytic Anemia
- ClinicalTrials.gov ID
- NCT04253236
- Acronym / sponsor ID
- ASCEND-WAIHA / RVT-1401-2003
- Conditions
- Warm Autoimmune Hemolytic Anemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Immunovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 28 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: RVT-1401 680 mg/weeklyDosing Regimen A - 680 mg weekly for 12 weeks via once weekly subcutaneous (SC) injections |
| Cohort 2 | Experimental | Drug: RVT-1401 340 mg/weeklyDosing Regimen B - 340 mg weekly for 12 weeks via once weekly subcutaneous (SC) injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
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 |
|---|---|---|
| RVT-1401 680 mg/weeklyNon-randomized subjects will receive subcutaneous injection of 680 mg weekly for 12 weeks of RVT-1401 | Drug | Cohort 1 |
| RVT-1401 340 mg/weeklyNon-randomized subjects will receive subcutaneous injection of 340 mg weekly for 12 weeks of RVT-1401 | Drug | Cohort 2 |
Primary outcome
Number of Responders at Week 13
Time frame: 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
Time frame: 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.
8 secondary outcomes
Time to Response
Time frame: Up to Week 13
Time to Achieving Hb Levels in the Normal Range
Time frame: Up to Week 13
Number of Participants With Change in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score
Time frame: Up to Week 13
Number of Participants With Change in Medical Research Council (MRC) Breathlessness Scale
Time frame: Up to Week 13
Number of Participants With Change in Euro Quality-5 Dimension-3 Level (EQ-5D-3L) Score
Time frame: Up to Week 20
Concentration of RVT-1401 Pre-dose
Time frame: Pre-dose, Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 13 post-dose
Number of Participants With Presence of Anti-RVT 1401 Antibodies
Time frame: Pre-dose on Weeks 1, 3, 5, 8, 13 and Week 20
Number of Participants With Change in Levels of Total Immunoglobulin (Ig)G and IgG Subclasses (1-4)
Time frame: Up to Week 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RVT-1401 680 mg/weekly and RVT-1401 340 mg/weekly in people with Warm Autoimmune Hemolytic Anemia, run by Immunovant Sciences GmbH at 21 sites in 6 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 7 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: stopped early, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in South Korea, United States, Thailand, Israel, Spain and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Responders at Week 13 (time frame: Week 13). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2022.