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JOURNAL ONKOLOGIE – STUDIE

Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis

Rekrutierend

NCT-Nummer:
NCT05403541

Studienbeginn:
Juni 2022

Letztes Update:
05.01.2024

Wirkstoff:
Batoclimab 680 mg SC weekly, Batoclimab 340 mg SC weekly, Matching Placebo SC, Batoclimab 340 mg SC bi-weekly

Indikation (Clinical Trials):
Myasthenia Gravis, Muscle Weakness

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Immunovant Sciences GmbH

Collaborator:
-

Kontakt

Studienlocations
(3 von 78)

Site Number -1032
94143 San Francisco
United StatesRekrutierend» Google-Maps
Site Number - 1028
33952 Port Charlotte
United StatesRekrutierend» Google-Maps
Site Number -1013
48824 East Lansing
United StatesRekrutierend» Google-Maps
Site Number - 1018
27599 Chapel Hill
United StatesRekrutierend» Google-Maps
Site Number - 1023
19104 Philadelphia
United StatesRekrutierend» Google-Maps
Site Number -1005
22908 Charlottesville
United StatesRekrutierend» Google-Maps
Site Number - 4013
355-0005 Higashimatsushima
JapanRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in

participants with gMG. In Period 1, participants will be randomized 1:1:1 to receive

batoclimab 680 milligrams (mg) subcutaneously (SC) once a week (QW) or 340 mg SC QW or

placebo. The primary efficacy endpoint will be assessed by change in the myasthenia gravis

activities of daily living (MG- ADL) score in acetylcholine receptor antibody seropositive

(AChRAb+) participants. In Period 2, participants previously treated with batoclimab will be

re-randomized to stay on batoclimab (340 mg SC QW or 340 mg SC every two weeks) or receive

placebo treatment. The secondary endpoint of maintenance of efficacy will be assessed by

change in the MG- ADL score in AChRAb+ participants. Participants demonstrating a response to

batoclimab during either Period 1 or 2 may enter the long-term extension (Period 3).

Participants who complete Period 3 are eligible to participate in Period 4 (Optional

Long-Term extension) according to their treatment assignment in Period 3.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Are ≥ 18 years of age at the Screening Visit.

2. Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA)

classification Class II, III, or IVa at the Screening Visit.

3. Have a QMG score ≥ 11 at the Screening and Baseline Visits.

4. Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits.

5. Additional inclusion criteria are defined in the protocol.

Exclusion Criteria:

1. Have experienced myasthenic crisis within 3 months of the Screening Visit.

2. Have had a thymectomy performed < 6 months prior to the Screening Visit or have a

planned thymectomy during the study period.

3. Have any active or untreated malignant thymoma.

4. Have received any agent or therapy (exclusive of those identified within inclusion

criteria) with immunosuppressive properties (e.g., stem cell therapy, chemotherapies)

within the past year.

5. Have used anti-FcRn treatment within 3 months prior to the Screening Visit or have a

documented history of non-response to prior anti-FcRn treatment.

6. Additional exclusion criteria are defined in the protocol.

Studien-Rationale

Primary outcome:

1. Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in acetylcholine receptor (AChR) Ab seropositive (AChRAb+) participants (Time Frame - Baseline (Day 1) to Week 12):
MG-ADL is an 8-item, participant-reported questionnaire that assesses gMG symptoms and their effects on activities of daily living. Each item is assessed on a 4-point scale where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. Total score ranges from 0 to 24, with higher scores indicating greater functional impairment and disability.



Secondary outcome:

1. Change from Baseline in Quantitative Myasthenia Gravis (QMG) score in AChRAb+ participants (Time Frame - Baseline (Day 1) to Week 12):
QMG is clinician-reported assessment to evaluate muscle weakness in participants with MG. The QMG consists of 13 items ranging from 0 to 3 with 3 being the most severe. Total score ranges from 0 to 39, with higher scores representing greater impairment.

2. Change from Baseline in MG-ADL score for AChRAb+ randomized withdrawal participants (Time Frame - Baseline (Week 12) to Week 24)

3. Percentage of AChRAb+ participants with greater than equal to (>=) 3-point improvement in QMG score (Time Frame - Up to Week 12)

4. Percentage of AChRAb+ participants achieving MG-ADL score of 0 or 1 by Week 12 (Time Frame - Up to Week 12)

5. Change from Baseline in MG-ADL score in AChRAB- (AChRAB negative) participants (Time Frame - Baseline (Day 1) to Week 12)

6. Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) (Time Frame - Up to 76 Weeks):
An adverse event (AE) is defined as any untoward medical occurrence in a participant who has either been administered a study drug or has undergone study procedures.

7. Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements (Time Frame - Up to 76 Weeks):
Vital signs, including systolic and diastolic blood pressures, pulse rate, respiratory rate, and temperature will be obtained and recorded at specified timepoints. All vital sign measures will be obtained with the participant in the supine position and having rested for at least 5 minutes.

8. Number of Participants with Clinically Significant Changes in Laboratory Results (Time Frame - Up to 76 Weeks):
Blood samples will be collected at specified timepoints for the analysis of laboratory parameters including clinical chemistry, hematology and urinalysis.

9. Percentage of participants with clinical laboratory-related TEAEs or treatment emergent laboratory abnormalities. (Time Frame - Up to 76 Weeks)

Studien-Arme

  • Experimental: Batoclimab Induction Dose 1 (Period 1)
  • Experimental: Batoclimab Induction Dose 2 (Period 1)
  • Placebo Comparator: Placebo Induction Dose (Period 1)
  • Experimental: Batoclimab Maintenance Dose 1 (Period 2)
  • Experimental: Batoclimab Maintenance Dose 2 (Period 2)
  • Placebo Comparator: Placebo Maintenance Dose (Period 2)

Geprüfte Regime

  • Batoclimab 680 mg SC weekly (IMVT-1401):
    Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
  • Batoclimab 340 mg SC weekly (IMVT-1401):
    Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
  • Matching Placebo SC:
    Placebo
  • Batoclimab 340 mg SC bi-weekly (IMVT-1401):
    Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

Quelle: ClinicalTrials.gov


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