Clinical Trials List
Protocol NumberDNTH103-MG-201
Completed
2025-02-01 - 2027-12-31
Phase II
Recruiting8
A randomized, blinded, placebo-controlled phase 2 trial evaluating the safety, tolerability, quantitative pharmacology, and efficacy (MAGIC) of DNTH103 in adult patients with generalized myasthenia gravis.
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Trial Applicant
CMIC Asia-Pacific
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Sponsor
CMIC ASIA-PACIFIC, PTE. LTD., TAIWAN BRANCH
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Trial scale
-
Update
2026/08/25
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林冠佑 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 季康揚 Division of Neurology
- Kon-Ping Lin Division of Neurology
- Yi-Chu Liao Division of Neurology
- 賴冠霖 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Fu-Yu Lin Division of Neurology
- 黃上芝 Division of Neurology
- Ching-Hua Lu Lu Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Long-Sun Ro
Co-Principal Investigator
- 朱俊哲 Division of Neurology
- Hong-Chou Kuo Division of Neurology
- 劉采薇 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
● Evaluate the safety and tolerability of DNTH103 in patients with generalized myasthenia gravis (gMG) up to week 13.
Objectives
The primary objective of this trial is to assess the safety and tolerability of the investigational drug DNTH103.
This trial investigates whether DNTH103, compared to a placebo, can help patients with generalized myasthenia gravis. The placebo (also known as a "dummy drug") looks identical to DNTH103 but contains no active pharmaceutical ingredient. The placebo is used to further observe the effects of DNTH103 and to help trial participants understand whether DNTH103 can help patients with generalized myasthenia gravis.
Test Drug
DNTH103 150 mg/mL
Active Ingredient
Human Immunoglobulin G
Dosage Form
Intravenous infusion
Dosage
MG
Endpoints
● Evaluate the safety and tolerability of DNTH103 in patients with generalized myasthenia gravis (gMG) up to week 13.
Inclution Criteria
1. Written informed consent must be obtained before any trial-related activities, and participants must understand the full nature and purpose of the trial, including potential risks and adverse reactions.
2. Adult men and women aged 18 to 75 years (inclusive) at the time of screening.
3. Weight between 40 and 120 kg at the time of screening.
4. A diagnosis of generalized myasthenia gravis must have been made at least 3 months (90 days) prior to the follow-up screening visit, confirmed according to inclusion criterion #5 below.
5. Diagnosis of generalized myasthenia gravis is based on the following tests:
a. A positive acetylcholine receptor antibody (AChR Ab) test during the screening period prior to randomization, and
b. Any of the following:
i. A history of abnormal neuromuscular conduction studies consistent with generalized myasthenia gravis, confirmed by single-fiber electromyography or repetitive electrical stimulation (rMS) testing;
ii. A history of a positive anticholinesterase test (e.g., edrophonium);
iii. A clinical response to an acetylcholinesterase inhibitor such as pyridostigmine (Mestinon®) as assessed by the treating physician.
6. Myasthenia Gravis Foundation (MGFA) class II-IVa at screening, confirmed during randomization.
7. A Myasthenia Gravis Daily Activities of Life (MG-ADL) score of 6 or higher at screening, confirmed during randomization.
8. Participants must have records showing that they received a meningococcal vaccine (including meningococcal B, if available) within the 3 years prior to enrollment, or received the vaccine at least 2 weeks (14 days) before randomization. Additionally, records should show that they received a pneumococcal and/or Haemophilus influenzae vaccine within the 3 years prior to enrollment, or, depending on local requirements and vaccine availability, received the vaccine at least 2 weeks (14 days) before randomization.
9. Participants using acetylcholinesterase inhibitors (e.g., pyridostigmine, Mestinon) at screening may continue to use them, provided that a stable daily dose is maintained for at least 2 weeks (14 days) before randomization.
10. At screening, participants must be receiving at least one, but no more than three, of the following immunosuppressant medications. The medication must be maintained at a stable daily dose for the shortest period specified below, and continuously throughout the trial:
a. If using oral corticosteroids, they must have been taken for at least 4 weeks (28 days) prior to randomization, at a dose not exceeding the average Prednisone dose of 40 mg/day (280 mg/week) or an equivalent;
b. If using azathioprine, it must have been taken for at least 6 months (180 days) prior to randomization, and a stable dose must have been maintained for at least 2 months (60 days) prior to randomization;
c. If using other immunosuppressants, other immunosuppressants (e.g., cyclosporine, mycophenolate mofetil, cyclophosphamide, or amiodarone) must have been used for at least 3 months (90 days) prior to randomization, and a stable dose must have been maintained for at least 1 month (30 days) prior to randomization.
11. Female participants must:
a. be infertile, i.e., have undergone laparoscopic sterilization at least 6 weeks prior to screening. If sterilization is performed via laparotomy, participants must have been menopausal for at least 12 weeks prior to screening, or have reached menopause (defined as 12 months without menstruation for no other medical reason, plus a follicle-stimulating hormone (FSH) concentration ≥ 40 IU/L at the time of screening), or
b. If fertile, participants must agree not to donate eggs or attempt pregnancy from the date of signing the participant consent form until the end of the trial period and the safety follow-up period (which may be longer if there are special regulations in China). If having sexual intercourse with a male partner, participants must agree to use a highly effective method of contraception.
12. Male participants must undergo surgical sterilization at least 90 days prior to screening, or agree not to donate sperm from the date of signing the participant consent form until the end of the trial period and the safety follow-up period (which may be longer if there are special regulations in China). If having sexual intercourse with a female partner capable of pregnancy, participants must agree to use an acceptable method of contraception.
13. No clinically significant abnormalities were observed during the screening period (at the discretion of the trial administrator), including:
a. No clinically significant findings in serum biochemistry, hematology, coagulation, and urinalysis.
b. Three repeated 12-lead electrocardiograms (ECGs) with a mean QT interval (QTcF) corrected using the Fridericia method: ≤ 450 ms for males and ≤ 460 ms for females, with no clinically significant abnormalities.
If any of the three readings from the first three repeated 12-lead ECGs is abnormal, a second evaluation may be conducted at the discretion of the trial administrator. ECG results outside the normal range are acceptable if the trial administrator deems them not clinically significant.
14. Willingness and ability to comply with all trial assessments and adherence to the trial protocol schedule and limitations.
2. Adult men and women aged 18 to 75 years (inclusive) at the time of screening.
3. Weight between 40 and 120 kg at the time of screening.
4. A diagnosis of generalized myasthenia gravis must have been made at least 3 months (90 days) prior to the follow-up screening visit, confirmed according to inclusion criterion #5 below.
5. Diagnosis of generalized myasthenia gravis is based on the following tests:
a. A positive acetylcholine receptor antibody (AChR Ab) test during the screening period prior to randomization, and
b. Any of the following:
i. A history of abnormal neuromuscular conduction studies consistent with generalized myasthenia gravis, confirmed by single-fiber electromyography or repetitive electrical stimulation (rMS) testing;
ii. A history of a positive anticholinesterase test (e.g., edrophonium);
iii. A clinical response to an acetylcholinesterase inhibitor such as pyridostigmine (Mestinon®) as assessed by the treating physician.
6. Myasthenia Gravis Foundation (MGFA) class II-IVa at screening, confirmed during randomization.
7. A Myasthenia Gravis Daily Activities of Life (MG-ADL) score of 6 or higher at screening, confirmed during randomization.
8. Participants must have records showing that they received a meningococcal vaccine (including meningococcal B, if available) within the 3 years prior to enrollment, or received the vaccine at least 2 weeks (14 days) before randomization. Additionally, records should show that they received a pneumococcal and/or Haemophilus influenzae vaccine within the 3 years prior to enrollment, or, depending on local requirements and vaccine availability, received the vaccine at least 2 weeks (14 days) before randomization.
9. Participants using acetylcholinesterase inhibitors (e.g., pyridostigmine, Mestinon) at screening may continue to use them, provided that a stable daily dose is maintained for at least 2 weeks (14 days) before randomization.
10. At screening, participants must be receiving at least one, but no more than three, of the following immunosuppressant medications. The medication must be maintained at a stable daily dose for the shortest period specified below, and continuously throughout the trial:
a. If using oral corticosteroids, they must have been taken for at least 4 weeks (28 days) prior to randomization, at a dose not exceeding the average Prednisone dose of 40 mg/day (280 mg/week) or an equivalent;
b. If using azathioprine, it must have been taken for at least 6 months (180 days) prior to randomization, and a stable dose must have been maintained for at least 2 months (60 days) prior to randomization;
c. If using other immunosuppressants, other immunosuppressants (e.g., cyclosporine, mycophenolate mofetil, cyclophosphamide, or amiodarone) must have been used for at least 3 months (90 days) prior to randomization, and a stable dose must have been maintained for at least 1 month (30 days) prior to randomization.
11. Female participants must:
a. be infertile, i.e., have undergone laparoscopic sterilization at least 6 weeks prior to screening. If sterilization is performed via laparotomy, participants must have been menopausal for at least 12 weeks prior to screening, or have reached menopause (defined as 12 months without menstruation for no other medical reason, plus a follicle-stimulating hormone (FSH) concentration ≥ 40 IU/L at the time of screening), or
b. If fertile, participants must agree not to donate eggs or attempt pregnancy from the date of signing the participant consent form until the end of the trial period and the safety follow-up period (which may be longer if there are special regulations in China). If having sexual intercourse with a male partner, participants must agree to use a highly effective method of contraception.
12. Male participants must undergo surgical sterilization at least 90 days prior to screening, or agree not to donate sperm from the date of signing the participant consent form until the end of the trial period and the safety follow-up period (which may be longer if there are special regulations in China). If having sexual intercourse with a female partner capable of pregnancy, participants must agree to use an acceptable method of contraception.
13. No clinically significant abnormalities were observed during the screening period (at the discretion of the trial administrator), including:
a. No clinically significant findings in serum biochemistry, hematology, coagulation, and urinalysis.
b. Three repeated 12-lead electrocardiograms (ECGs) with a mean QT interval (QTcF) corrected using the Fridericia method: ≤ 450 ms for males and ≤ 460 ms for females, with no clinically significant abnormalities.
If any of the three readings from the first three repeated 12-lead ECGs is abnormal, a second evaluation may be conducted at the discretion of the trial administrator. ECG results outside the normal range are acceptable if the trial administrator deems them not clinically significant.
14. Willingness and ability to comply with all trial assessments and adherence to the trial protocol schedule and limitations.
Exclusion Criteria
1. Past or present major medical/surgical conditions, including any acute illness or major surgery, deemed clinically significant by the trial administrator, or potentially affecting safety/efficacy or trial procedures.
2. Clinically characteristic at screening follow-up or at any time from screening to randomization, deemed by the trial administrator to be consistent with myasthenic crisis/exacerbation.
3. History of known complement deficiency or positive anti-C1 antibody titer.
4. Previous infection (at any time) with meningococcus.
5. Positive results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody during screening. Participants without evidence of cirrhosis, who have completed hepatitis C eradication therapy, and who are deemed by a gastroenterologist to be free of active hepatitis C virus are eligible for inclusion in the trial.
6. Currently or previously using complement inhibitors, or currently using anti-neonatal Fc receptor (FcRN) drugs. Participants who have previously used anti-Fc receptor drugs and whose last dose was at least 5 half-lives or 90 days (whichever is longer) prior to randomization (day 1) may be considered for inclusion after review and approval by the medical monitor.
7. Have undergone any thymic surgery/tissue biopsy within 1 year prior to screening.
8. Any known or untreated thymoma. Thymomas that have been resected (if surgery/resection was performed at least 1 year prior to screening) are permitted if they are confirmed to be non-recurrent within 6 months prior to screening or during screening (confirmed by chest CT or MRI).
9. History of thymic carcinoma or thymic malignancy.
10. History of active malignancy within 5 years prior to screening, excluding basal cell carcinoma of the skin, healed squamous cell carcinoma of the skin, cured cervical carcinoma in situ, or low-grade prostate cancer, for which the management is only suitable for observation.
11. Hospitalization for more than 24 hours within 6 weeks (42 days) prior to screening, excluding scheduled medical treatment.
12. Liver function test results showing a level of alanine aminotransferase (ALT), total bilirubin, aspartate transaminase (AST), or alanine transaminase (ALT) more than twice the upper limit of normal.
13. Use of the following medications concurrently with or prior to the specified time periods.
a. Received rituximab within 6 months (180 days) prior to randomization (Day 1);
b. Received intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28 days) prior to randomization (Day 1).
14. Received any live vaccine within 30 days prior to randomization (Day 1), or is expected to receive a live vaccine during the trial.
15. Clinically significant drug or alcohol abuse as determined by the trial administrator.
16. Known allergy to any component of the investigational drug.
17. For women of childbearing age, a positive serum pregnancy test during screening, or a positive urine pregnancy test at the time of randomization (confirmed by serum pregnancy test).
18. A woman who is breastfeeding, or plans to breastfeed at any time during the trial.
19. Participation in another clinical trial of the investigational drug within 90 days prior to randomization (Day 1) or within five half-lives of the investigational drug (whichever is longer).
20. Concomitant medical conditions or their treatment that may affect trial evaluation or outcomes.
21. Any other condition, including mental illness or prior therapy, that, in the assessment of the trial administrator, may render the participant unsuitable for this trial, including inability to fully comply with the trial protocol or potential non-compliance.
22. Diagnosis of systemic lupus erythematosus (SLE) or a family history of SLE (defined as parents or siblings).
23. Diagnosis of an autoimmune disease other than generalized myasthenia gravis. Exceptions to other autoimmune diseases (excluding SLE) may be permitted upon review and approval by the medical monitor on a case-by-case basis.
24. Antinuclear antibody (ANA) titer ≥ 1:320, or both antinuclear antibody (any titer) and anti-double-stranded (ds) DNA antibody are positive.
2. Clinically characteristic at screening follow-up or at any time from screening to randomization, deemed by the trial administrator to be consistent with myasthenic crisis/exacerbation.
3. History of known complement deficiency or positive anti-C1 antibody titer.
4. Previous infection (at any time) with meningococcus.
5. Positive results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody during screening. Participants without evidence of cirrhosis, who have completed hepatitis C eradication therapy, and who are deemed by a gastroenterologist to be free of active hepatitis C virus are eligible for inclusion in the trial.
6. Currently or previously using complement inhibitors, or currently using anti-neonatal Fc receptor (FcRN) drugs. Participants who have previously used anti-Fc receptor drugs and whose last dose was at least 5 half-lives or 90 days (whichever is longer) prior to randomization (day 1) may be considered for inclusion after review and approval by the medical monitor.
7. Have undergone any thymic surgery/tissue biopsy within 1 year prior to screening.
8. Any known or untreated thymoma. Thymomas that have been resected (if surgery/resection was performed at least 1 year prior to screening) are permitted if they are confirmed to be non-recurrent within 6 months prior to screening or during screening (confirmed by chest CT or MRI).
9. History of thymic carcinoma or thymic malignancy.
10. History of active malignancy within 5 years prior to screening, excluding basal cell carcinoma of the skin, healed squamous cell carcinoma of the skin, cured cervical carcinoma in situ, or low-grade prostate cancer, for which the management is only suitable for observation.
11. Hospitalization for more than 24 hours within 6 weeks (42 days) prior to screening, excluding scheduled medical treatment.
12. Liver function test results showing a level of alanine aminotransferase (ALT), total bilirubin, aspartate transaminase (AST), or alanine transaminase (ALT) more than twice the upper limit of normal.
13. Use of the following medications concurrently with or prior to the specified time periods.
a. Received rituximab within 6 months (180 days) prior to randomization (Day 1);
b. Received intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28 days) prior to randomization (Day 1).
14. Received any live vaccine within 30 days prior to randomization (Day 1), or is expected to receive a live vaccine during the trial.
15. Clinically significant drug or alcohol abuse as determined by the trial administrator.
16. Known allergy to any component of the investigational drug.
17. For women of childbearing age, a positive serum pregnancy test during screening, or a positive urine pregnancy test at the time of randomization (confirmed by serum pregnancy test).
18. A woman who is breastfeeding, or plans to breastfeed at any time during the trial.
19. Participation in another clinical trial of the investigational drug within 90 days prior to randomization (Day 1) or within five half-lives of the investigational drug (whichever is longer).
20. Concomitant medical conditions or their treatment that may affect trial evaluation or outcomes.
21. Any other condition, including mental illness or prior therapy, that, in the assessment of the trial administrator, may render the participant unsuitable for this trial, including inability to fully comply with the trial protocol or potential non-compliance.
22. Diagnosis of systemic lupus erythematosus (SLE) or a family history of SLE (defined as parents or siblings).
23. Diagnosis of an autoimmune disease other than generalized myasthenia gravis. Exceptions to other autoimmune diseases (excluding SLE) may be permitted upon review and approval by the medical monitor on a case-by-case basis.
24. Antinuclear antibody (ANA) titer ≥ 1:320, or both antinuclear antibody (any titer) and anti-double-stranded (ds) DNA antibody are positive.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
60 participants
