Plain English Summary
Background and study aims
The current approach is to observe the safety and tolerability of the study drug, how the drug moves within the body or pharmacokinetics (PK), and how it interacts with the body or pharmacodynamics (PD) in healthy volunteers and participants with autoimmune diseases.
Who can participate?
Healthy volunteers and participants aged between 18 to 55 years old and participants with autoimmune diseases aged between 18 and 75 years old.
What does the study involve?
This study consists of 2 parts. Part 1 will investigate the safety, tolerability, PK, and PD of single and multiple ascending doses (SAD and MAD) of IMVT-1402 in healthy adult male participants and adult female participants of non-childbearing potential (NCBP). In addition to the SAD and MAD cohorts, there is 1 Alternative Dose Regimen cohort that will receive standard treatment or placebo. Up to approximately 108 participants will be enrolled in the study. In Part 1, eligible participants will be randomized to receive either standard treatment or a placebo. Part 2 aims to investigate the safety, tolerability, PD, PK, and efficacy of 12 weeks of weekly SC dosing with IMVT-1402 in adults with autoimmune diseases. In Part 2, all participants will receive study treatment.
A total of up to approximately 168 participants will be enrolled in the study.
What are the possible benefits and risks of participating?
There is no direct benefit to participants in Part 1 of this study. However, the results of the study may lead to a better understanding and treatment of IgG autoantibody-mediated diseases. Participants in Part 2 may receive clinical benefits from participation in this study. This study may lead to a better understanding of IgG autoantibody-mediated diseases.
Where is the study run from?
Immunovant Sciences GmbH (Switzerland)
When is the study starting and how long is it expected to run for?
December 2022 to February 2025
Who is funding the study?
Immunovant Sciences GmbH (Switzerland)
Who is the main contact?
Dr Rohit Katial, rohit.katial@nzcr.co.nz
Study website
Contact information
Type
Principal Investigator
Contact name
Dr Rohit Katial
ORCID ID
Contact details
3 Ferncroft Street
Grafton
Auckland
1010
New Zealand
+64 08007883437
rohit.katial@nzcr.co.nz
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
IMVT-1402-1001
Study information
Scientific title
A phase I, randomized, double-blind, placebo-controlled, ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMVT-1402 following single and multiple doses in healthy participants and open-label cohorts in participants with autoimmune diseases
Acronym
Study hypothesis
Current study hypothesis as of 11/03/2024:
Part 1 of the study aims to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses (SAD), multiple ascending doses (MAD), and an alternative dose regimen of IMVT-1402 in healthy adult male participants and adult female participants of non-childbearing potential (NCBP). Part 2 aims to investigate the safety, tolerability, PD, PK, and efficacy of 12 weeks of weekly SC dosing of IMVT-1402 in adults with autoimmune diseases.
Previous study hypothesis as of 04/12/2023 to 11/03/2024:
Study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses (SAD), multiple ascending doses (MAD), and an alternative dose regimen of IMVT-1402 in healthy adult male participants and adult female participants of non-childbearing potential (NCBP).
Previous study hypothesis:
Study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses (SAD) and multiple ascending doses (MAD) of IMVT-1402 in healthy adult male participants and adult female participants of non-childbearing potential (NCBP).
Ethics approval(s)
Approved 15/05/2023, Central Health and Disability Ethics Committees (Ministry of Health, Health and Disability Ethics Committee, Wellington 6011, PO Box 5013, New Zealand; +64 0800 438 442; hdecs@health.govt.nz), ref: 2023 FULL 15579
Study design
Part 1 interventional randomized controlled double-blind study with a Part 2 open-label study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Pharmaceutical testing facility
Study type
Treatment
Patient information sheet
Not available in web format
Condition
Healthy volunteers and adults with autoimmune diseases
Intervention
Current interventions as of 11/03/2024:
In Part 1, participants will be randomized using simple randomization without stratification to receive either a single Intravenous (IV) Dose A, single IV Dose B, single subcutaneous (SC) Dose C, multiple SC Dose D, single IV Dose E, single SC Dose F, multiple SC Dose G, single IV Dose H, multiple SC Dose I (optional) and multiple SC Dose J (optional) of IMVT-1402 or placebo. The additional alternative dose regimen cohort will be randomized to receive either multiple SC Dose K of IMVT-1402 or placebo. IMVT-1402 and placebo are sterile SC or IV injections.
In Part 2, participants will receive open-label SC Dose G once weekly (QW). IMVT-1402 is a sterile SC injection.
Previous interventions as of 04/12/2023 to 11/03/2024:
Participants will be randomized using simple randomization without stratification to receive either a single Intravenous (IV) Dose A, single IV Dose B, single subcutaneous (SC) Dose C, multiple SC Dose D, single IV Dose E, single SC Dose F, multiple SC Dose G, single IV Dose H, multiple SC Dose I (optional) and multiple SC Dose J (optional) of IMVT-1402 or placebo. The additional alternative dose regimen cohort will be randomized to receive either multiple SC Dose K of IMVT-1402 or placebo. IMVT-1402 and placebo are sterile SC or IV injections.
Previous interventions as of 23/05/2023 to 04/12/2023:
Participants will be randomized using simple randomization without stratification to receive either a single Intravenous (IV) Dose A, single IV Dose B, single subcutaneous (SC) Dose C, multiple SC Dose D, single IV Dose E, single SC Dose F, multiple SC Dose G, single IV Dose H, multiple SC Dose I (optional) and multiple SC Dose J (optional) of IMVT-1402 or placebo. IMVT-1402 and placebo are sterile SC or IV injections.
Previous interventions:
Participants will be randomized to receive either a single Intravenous (IV) Dose A, single IV Dose B, single subcutaneous (SC) Dose C, multiple SC Dose D, single IV Dose E, single SC Dose F, multiple SC Dose G, single IV Dose H, multiple SC Dose I (optional) and multiple SC Dose J (optional) of IMVT-1402 or placebo. IMVT-1402 and placebo is a sterile SC or IV injection.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase I
Drug/device/biological/vaccine name(s)
IMVT-1402
Primary outcome measure
Current primary outcome measure as of 11/03/2024:
1. Part 1: Adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation measured using study records up to 13 weeks for SAD, up to 16 weeks for MAD, and 10 weeks for the alternative dose regimen cohort.
2. Part 2: AEs, SAEs, and AEs leading to study treatment discontinuation measured using study records up to 16 weeks.
Previous primary outcome measure as of 04/12/2023 to 11/03/2024:
Adverse events (AEs), serious adverse events (SAEs), AEs leading to study treatment discontinuation measured using study records up to 13 weeks for SAD, up to 16 weeks for MAD, and 10 weeks for the alternative dose regimen cohort.
Previous primary outcome measure:
Adverse events (AEs), serious adverse events (SAEs), AEs leading to study treatment discontinuation measured using study records up to 13 weeks for SAD and up to 16 weeks for MAD
Secondary outcome measures
Current secondary outcome measures as of 11/03/2024:
1. Part 1 and Part 2: Serum concentrations of IMVT-1402 measured using blood samples will be collected up to Day 85 for Part 1 and up to Week 16 for Part 2. Pharmacokinetics will be analyzed using non-compartmental analysis.
2. Part 1 and Part 2: Serum concentrations of PD parameters including Total Immunoglobulin (IgG), IgG1, IgG2, IgG3 and IgG4 up to Day 85 for Part 1 and up to Week 16 for Part 2. Pharmacodynamics will be analyzed using the Pharmacodynamic analysis set (PDAS).
3. Part 1 and Part 2: Number of participants with treatment-emergent positive anti-drug antibodies (ADAs) and neutralizing antibodies (nAbs) up to Day 85 for Part 1 and up to Week 16 for Part 2. The ADA analysis will be based on the anti-drug antibodies analysis set (ADAAS).
Previous secondary outcome measures as of 23/05/2023 to 11/03/2024:
1. Serum concentrations of IMVT-1402 measured using blood samples will be collected up to Day 85. Pharmacokinetics will be analyzed using non-compartmental analysis.
2. Serum concentrations of PD parameters including Total Immunoglobulin (IgG), IgG1, IgG2, IgG3 and IgG4 up to Day 85. Pharmacodynamics will be analyzed using the Pharmacodynamic analysis set (PDAS).
3. Number of participants with treatment-emergent positive anti-drug antibodies (ADAs) and neutralizing antibodies (nAbs) up to Day 85. The ADA analysis will be based on the anti-drug antibodies analysis set (ADAAS).
Previous secondary outcome measures:
1. Serum concentrations of IMVT-1402 up to Day 85
2. Serum concentrations of PD parameters including Total Immunoglobulin (IgG), IgG1, IgG2, IgG3 and IgG4 up to Day 85
3. Number of participants with treatment-emergent positive anti-drug antibodies (ADAs) and neutralizing antibodies (nAbs) up to Day 85
Overall study start date
21/12/2022
Overall study end date
14/02/2025
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current participant inclusion criteria as of 11/03/2024:
Participants between the ages of 18 and 75 years old will be included.
Previous participant inclusion criteria:
1. Have a body weight of ≥50 kg
2. Are willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and testing schedule
3. Have adequate venous access, assessed at the time of screening, that allows for IV dosing and/or repeated phlebotomy
4. Are healthy as determined by the Investigator based on a medical evaluation including medical history, physical examination, laboratory tests, and Electrocardiogram (ECG).
5. Are female, not lactating, and of NCBP
6. Are male and have had a vasectomy >6 months prior to the Screening Visit or agree to use contraceptive methods starting at the Screening Visit and continuing throughout the study and for 90 days after the final study treatment administration
Participant type(s)
Healthy volunteer, Patient
Age group
Mixed
Lower age limit
18 Years
Upper age limit
75 Years
Sex
Both
Target number of participants
168
Participant exclusion criteria
Current participant exclusion criteria as of 11/03/2024:
Not meeting the inclusion criteria.
Previous participant exclusion criteria:
1. Have any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as judged by the Investigator.
2. Have an active malignancy or history of malignancy in the 3 years prior to the Screening Visit (exclusive of non-melanoma skin cancer, cervical cancer in situ or prostate cancer in situ) or any history of malignancy not deemed cured by adequate treatment.
3. Have any clinically significant history of allergic conditions, including drug allergies, anaphylactic reactions, or hypersensitivity to study treatments or components. Participants with currently asymptomatic, seasonal allergies or exercise-induced bronchospasm prior to study treatment administration are eligible.
4. Have undergone any blood loss or phlebotomy with removal of ≥500 milliliter (mL) of blood within 56 days prior to the Screening Visit.
5. Have received a transfusion of any blood or blood products within 56 days or donated plasma within 7 days prior to the Screening Visit.
6. Have participated in any other study involving an investigational product (IP) within the last 30 days or 5 half-lives, whichever is greater, (6 months for anti-neonatal fragment crystallizable receptor [FcRn] therapy), prior to the Screening Visit or during the study.
Recruitment start date
18/05/2023
Recruitment end date
30/01/2025
Locations
Countries of recruitment
New Zealand
Study participating centre
New Zealand Clinical Research OPCO Ltd
Grd Floor 3, Ferncroft St, Grafton
Auckland
1010
New Zealand
Study participating centre
New Zealand Clinical Research - Christchurch
264 Antigua Street
Christchurch, Canterbury
8011
New Zealand
Sponsor information
Organisation
Immunovant Sciences GmbH
Sponsor details
Viaduktstrasse 8
Basel
4051
Switzerland
+41 18007970414
clinicaltrials@immunovant.com
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Immunovant Sciences GmbH
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
Intention to publish date
31/12/2025
Individual participant data (IPD) sharing plan
Current IPD sharing statement as of 23/05/2023:
The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality reasons.
Previous IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|