Safety, tolerability, pharmacokinetics, and pharmacodynamics of single/multiple doses of IMVT-1402 in healthy participants and participants with autoimmune diseases
| ISRCTN | ISRCTN11659633 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11659633 |
| Secondary identifying numbers | IMVT-1402-1001 |
- Submission date
- 09/05/2023
- Registration date
- 16/05/2023
- Last edited
- 11/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
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 three 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 study treatment or placebo. Up to approximately 108 participants will be enrolled in Part 1 of the study. In Part 1, eligible participants will be randomized to receive either study 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 48 adult participants with autoimmune diseases. In Part 2, all participants will receive study treatment. Part 3 of the study is an optional open-label long-term extension (LTE) and will include participants who have completed Part 2 and shown adequate clinical response in the opinion of the Investigator. The total duration of the LTE phase is 92 weeks, during which participants will continue receiving the same study treatment as in Part 2.
A total of up to approximately 156 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 Part 1 of the study may lead to a better understanding and treatment of IgG autoantibody-mediated diseases.
Participants in Part 2 and Part 3 may receive clinical benefits from participation in this study.
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 July 2028
Who is funding the study?
Immunovant Sciences GmbH (Switzerland)
Who is the main contact?
Dr Rohit Katial, rohit.katial@nzcr.co.nz
Contact information
Principal Investigator
3 Ferncroft Street
Grafton
Auckland
1010
New Zealand
| Phone | +64 08007883437 |
|---|---|
| rohit.katial@nzcr.co.nz |
Study information
| Study design | Part 1 is an interventional randomized controlled double-blind study. Part 2 is an open-label study followed by Part 3, which is an optional open-label long-term extension |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Treatment |
| Participant information sheet | Not available in web format |
| 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 |
| Study hypothesis | Current study hypothesis as of 11/04/2025: 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 adult participants with autoimmune diseases. Part 3 aims to evaluate the long-term safety and tolerability of IMVT-1402 in participants with autoimmune diseases. Previous study hypothesis from 11/03/2024 to 11/04/2025: 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). Original 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 |
| Condition | Healthy volunteers and adults with autoimmune diseases |
| Intervention | Current interventions as of 11/04/2025: 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 and Part 3, participants will receive open-label SC Dose G once weekly (QW). IMVT-1402 is a sterile SC injection. Previous interventions from 11/03/2024 to 11/04/2025: 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 from 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 from 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 11/04/2025: 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 for up to 16 weeks. 3. Part 3: AEs, SAEs, and AEs leading to study treatment discontinuation are measured using study records from Week 12 through Week 108. Previous primary outcome measure from 11/03/2024 to 11/04/2025: 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 from 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 | 31/07/2028 |
Eligibility
| 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 | 156 |
| Participant inclusion criteria | Current participant inclusion criteria as of 11/03/2024: Participants between the ages of 18 and 75 years 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 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 | 31/07/2026 |
Locations
Countries of recruitment
- New Zealand
Study participating centres
Auckland
1010
New Zealand
Christchurch, Canterbury
8011
New Zealand
Sponsor information
Research organisation
Viaduktstrasse 8
Basel
4051
Switzerland
| Phone | +41 18007970414 |
|---|---|
| clinicaltrials@immunovant.com | |
| Website | https://www.immunovant.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| 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 |
Editorial Notes
11/04/2025: The following changes were made to the study record and the plain English summary was amended to reflect those changes:
1. The study hypothesis, interventions, primary outcome measures,
2. The study design was changed from 'Part 1 interventional randomized controlled double-blind study with a Part 2 open-label study' to 'Part 1 is an interventional randomized controlled double-blind study. Part 2 is an open-label study followed by Part 3, which is an optional open-label long-term extension'.
3. The target number of participants was changed from 168 to 156.
4. The overall study end date was changed from 14/02/2025 to 31/07/2028.
5. The recruitment end date was changed from 30/01/2025 to 31/07/2026.
11/03/2024: The following changes have been made and the plain English summary was amended to reflect those changes:
1. The public title was changed from "Safety, tolerability, pharmacokinetics, and pharmacodynamics of single/multiple doses of IMVT-1402 in healthy participants" to "Safety, tolerability, pharmacokinetics, and pharmacodynamics of single/multiple doses of IMVT-1402 in healthy participants and participants with autoimmune diseases".
2. The scientific title was changed from "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" to "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".
3. The study hypothesis was changed.
4. The study design was changed from "Interventional randomized controlled double-blind study" to "Part 1 interventional randomized controlled double-blind study with a Part 2 open-label study".
5. The condition was changed from "Healthy volunteers" to "Healthy volunteers and adults with autoimmune diseases".
6. The condition category was changed from "Not applicable" to "Musculoskeletal diseases".
7. The interventions were changed.
8. The primary outcome measure was changed.
9. The secondary outcome measures were changed.
10. The overall study end date was changed from 14/02/2024 to 14/02/2025.
11. The participant inclusion criteria were changed.
12. The age group was changed from adult to mixed.
13. Lower and upper ages added with units.
12. The participant exclusion criteria were changed.
13. Patient was added as a participant type.
14. The target number of participants was changed from 108 to 168.
15. The recruitment end date was changed from 30/01/2024 to 30/01/2025.
16. The study participating centre New Zealand Clinical Research - Christchurch was added.
04/12/2023: The following changes have been made:
1. The study hypothesis was changed.
2. The interventions were changed.
3. The primary outcome measure was changed.
4. The overall study end date was changed from 15/01/2024 to 14/02/2024.
5. The target number of participants was changed from 96 to 108.
6. The recruitment start date was changed from 31/05/2023 to 18/05/2023.
7. The recruitment end date was changed from 22/09/2023 to 30/01/2024.
8. The plain English summary was updated to reflect the above changes.
9. The funder was changed from "Investigator initiated and funded" to "Immunovant Sciences GmbH".
26/10/2023: The recruitment end date was changed from 10/10/2023 to 22/09/2023.
23/05/2023: The following updates have been made to the study record and the plain English summary updated accordingly:
1. The study contact has been updated.
2. The interventions have been changed.
3. The overall trial end date has been changed from 26/04/2023 to 21/12/2022.
4. The secondary outcome measures have been changed.
5. The publication and dissemination plan has been added.
6. The intention to publish date has been added.
7. The individual participant data (IPD) sharing statement has been changed.
16/05/2023: Trial's existence confirmed by the Central Health and Disability Ethics Committee.
