Trial Outcomes & Findings for Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200 (NCT NCT05034874)
NCT ID: NCT05034874
Last Updated: 2024-10-04
Results Overview
The difference in group means between the IXT-m200 and placebo groups for the percent of 20 weeks abstinent from stimulants following a 4-week grace period as measured by saliva screens in treatment-seeking individuals with Methamphetamine Use Disorder. All observations will be used, regardless of whether a participant discontinued treatment early. All missing values will be imputed assuming the participant is not abstinent.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
20 weeks
Results posted on
2024-10-04
Participant Flow
Patients were required to qualify for the study by complying with app-based drug testing assignments. In addition, one of the drug tests performed during the screening period must have been positive for methamphetamine (METH) to qualify.
Participant milestones
| Measure |
IXT-m200
Anti-methamphetamine monoclonal antibody, dose level of 1.5 g
IXT-m200: IXT-m200 binds METH with high selectivity and affinity. The product contains a murine METH-binding variable region and the constant domains of a human immunoglobulin G (IgG) 2κ. This antibody isotype was chosen because of the lower risk of immune response compared to an IgG1 or IgG3. IXT-m200 targets METH, does not rely on binding to any endogenous target for its action, and has been well-tolerated in previous clinical studies.
|
Placebo
Saline
Placebo: Saline
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
20
|
|
Overall Study
COMPLETED
|
15
|
4
|
|
Overall Study
NOT COMPLETED
|
26
|
16
|
Reasons for withdrawal
| Measure |
IXT-m200
Anti-methamphetamine monoclonal antibody, dose level of 1.5 g
IXT-m200: IXT-m200 binds METH with high selectivity and affinity. The product contains a murine METH-binding variable region and the constant domains of a human immunoglobulin G (IgG) 2κ. This antibody isotype was chosen because of the lower risk of immune response compared to an IgG1 or IgG3. IXT-m200 targets METH, does not rely on binding to any endogenous target for its action, and has been well-tolerated in previous clinical studies.
|
Placebo
Saline
Placebo: Saline
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
18
|
8
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Skipped final visits, checked into rehab
|
2
|
1
|
Baseline Characteristics
Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200
Baseline characteristics by cohort
| Measure |
IXT-m200
n=41 Participants
Anti-methamphetamine monoclonal antibody, dose level of 1.5 g
IXT-m200: IXT-m200 binds METH with high selectivity and affinity. The product contains a murine METH-binding variable region and the constant domains of a human immunoglobulin G (IgG) 2κ. This antibody isotype was chosen because of the lower risk of immune response compared to an IgG1 or IgG3. IXT-m200 targets METH, does not rely on binding to any endogenous target for its action, and has been well-tolerated in previous clinical studies.
|
Placebo
n=20 Participants
Saline
Placebo: Saline
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.2 years
STANDARD_DEVIATION 10.13 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 7.63 • n=7 Participants
|
43.0 years
STANDARD_DEVIATION 9.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Days per month of METH use
<18 days per month
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Days per month of METH use
≥18 days per month
|
39 participants
n=5 Participants
|
19 participants
n=7 Participants
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 weeksPopulation: Intent to treat
The difference in group means between the IXT-m200 and placebo groups for the percent of 20 weeks abstinent from stimulants following a 4-week grace period as measured by saliva screens in treatment-seeking individuals with Methamphetamine Use Disorder. All observations will be used, regardless of whether a participant discontinued treatment early. All missing values will be imputed assuming the participant is not abstinent.
Outcome measures
| Measure |
IXT-m200
n=41 Participants
Anti-methamphetamine monoclonal antibody, dose level of 1.5 g
IXT-m200: IXT-m200 binds METH with high selectivity and affinity. The product contains a murine METH-binding variable region and the constant domains of a human immunoglobulin G (IgG) 2κ. This antibody isotype was chosen because of the lower risk of immune response compared to an IgG1 or IgG3. IXT-m200 targets METH, does not rely on binding to any endogenous target for its action, and has been well-tolerated in previous clinical studies.
|
Placebo
n=20 Participants
Saline
Placebo: Saline
|
|---|---|---|
|
Percent of 20 Weeks Abstinent From Stimulants Following a 4-week Grace Period
|
5.9 percentage of 20 weeks abstinent
Standard Deviation 17.33
|
4.3 percentage of 20 weeks abstinent
Standard Deviation 8.73
|
SECONDARY outcome
Timeframe: Weeks 13, 25, and 33Population: Intent to treat
Treatment Effectiveness Assessment (TEA) asks questions in four domains with results ranging from 4-40 with higher scores representing a better outcome.
Outcome measures
| Measure |
IXT-m200
n=41 Participants
Anti-methamphetamine monoclonal antibody, dose level of 1.5 g
IXT-m200: IXT-m200 binds METH with high selectivity and affinity. The product contains a murine METH-binding variable region and the constant domains of a human immunoglobulin G (IgG) 2κ. This antibody isotype was chosen because of the lower risk of immune response compared to an IgG1 or IgG3. IXT-m200 targets METH, does not rely on binding to any endogenous target for its action, and has been well-tolerated in previous clinical studies.
|
Placebo
n=20 Participants
Saline
Placebo: Saline
|
|---|---|---|
|
Change From Screening in Participant-rated Quality of Life as Measured by the Treatment Effectiveness Assessment at Week 13, 25, and 33.
Week 13
|
6.2 score on a scale
Standard Deviation 8.67
|
4.6 score on a scale
Standard Deviation 8.16
|
|
Change From Screening in Participant-rated Quality of Life as Measured by the Treatment Effectiveness Assessment at Week 13, 25, and 33.
Week 25
|
7.3 score on a scale
Standard Deviation 9.07
|
17 score on a scale
Standard Deviation 9.09
|
|
Change From Screening in Participant-rated Quality of Life as Measured by the Treatment Effectiveness Assessment at Week 13, 25, and 33.
Week 33
|
11 score on a scale
Standard Deviation 9.32
|
13.5 score on a scale
Standard Deviation 10.25
|
SECONDARY outcome
Timeframe: 25 weeksPopulation: Intent to treat
A responder is defined as a participant who meets the definition of early remission, i.e., at least 3 months and \<12 months without meeting DSM-5 criteria other than craving.
Outcome measures
| Measure |
IXT-m200
n=41 Participants
Anti-methamphetamine monoclonal antibody, dose level of 1.5 g
IXT-m200: IXT-m200 binds METH with high selectivity and affinity. The product contains a murine METH-binding variable region and the constant domains of a human immunoglobulin G (IgG) 2κ. This antibody isotype was chosen because of the lower risk of immune response compared to an IgG1 or IgG3. IXT-m200 targets METH, does not rely on binding to any endogenous target for its action, and has been well-tolerated in previous clinical studies.
|
Placebo
n=20 Participants
Saline
Placebo: Saline
|
|---|---|---|
|
Proportion of Responders in Early Remission at Week 25 as Measured by DSM-5 Criteria
|
2.4 percentage of responders
|
0 percentage of responders
|
SECONDARY outcome
Timeframe: Weeks 13, 25, and 33Population: Intent to treat
The CGIC asks clinicians to complete one statement with the result ranging from 1-7 with lower scores representing a better outcome.
Outcome measures
| Measure |
IXT-m200
n=41 Participants
Anti-methamphetamine monoclonal antibody, dose level of 1.5 g
IXT-m200: IXT-m200 binds METH with high selectivity and affinity. The product contains a murine METH-binding variable region and the constant domains of a human immunoglobulin G (IgG) 2κ. This antibody isotype was chosen because of the lower risk of immune response compared to an IgG1 or IgG3. IXT-m200 targets METH, does not rely on binding to any endogenous target for its action, and has been well-tolerated in previous clinical studies.
|
Placebo
n=20 Participants
Saline
Placebo: Saline
|
|---|---|---|
|
Difference Between Groups in Clinical Global Impression of Change (CGIC) at Week 13, 25, and 33
Week 13
|
3 score on a scale
Standard Deviation 1.11
|
3 score on a scale
Standard Deviation 0.87
|
|
Difference Between Groups in Clinical Global Impression of Change (CGIC) at Week 13, 25, and 33
Week 25
|
3.1 score on a scale
Standard Deviation 0.89
|
2.3 score on a scale
Standard Deviation 0.96
|
|
Difference Between Groups in Clinical Global Impression of Change (CGIC) at Week 13, 25, and 33
Week 33
|
2.7 score on a scale
Standard Deviation 1.28
|
2 score on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Weeks 13, 25, and 33Population: Intent to treat
The PGIC asks patients to complete one statement with the result ranging from 1-7 with lower scores representing a better outcome.
Outcome measures
| Measure |
IXT-m200
n=41 Participants
Anti-methamphetamine monoclonal antibody, dose level of 1.5 g
IXT-m200: IXT-m200 binds METH with high selectivity and affinity. The product contains a murine METH-binding variable region and the constant domains of a human immunoglobulin G (IgG) 2κ. This antibody isotype was chosen because of the lower risk of immune response compared to an IgG1 or IgG3. IXT-m200 targets METH, does not rely on binding to any endogenous target for its action, and has been well-tolerated in previous clinical studies.
|
Placebo
n=20 Participants
Saline
Placebo: Saline
|
|---|---|---|
|
Difference Between Groups in Patient Global Impression of Change (PGIC) at Week 13, 25, and 33
Week 13
|
2.8 score on a scale
Standard Deviation 1.22
|
3 score on a scale
Standard Deviation 0.87
|
|
Difference Between Groups in Patient Global Impression of Change (PGIC) at Week 13, 25, and 33
Week 25
|
3 score on a scale
Standard Deviation 1.55
|
2.5 score on a scale
Standard Deviation 1.29
|
|
Difference Between Groups in Patient Global Impression of Change (PGIC) at Week 13, 25, and 33
Week 33
|
2.3 score on a scale
Standard Deviation 1.39
|
1.8 score on a scale
Standard Deviation 0.96
|
Adverse Events
IXT-m200
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IXT-m200
n=41 participants at risk
Anti-methamphetamine monoclonal antibody, dose level of 1.5 g
IXT-m200: IXT-m200 binds METH with high selectivity and affinity. The product contains a murine METH-binding variable region and the constant domains of a human immunoglobulin G (IgG) 2κ. This antibody isotype was chosen because of the lower risk of immune response compared to an IgG1 or IgG3. IXT-m200 targets METH, does not rely on binding to any endogenous target for its action, and has been well-tolerated in previous clinical studies.
|
Placebo
n=20 participants at risk
Saline
Placebo: Saline
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/41 • 32 weeks
|
5.0%
1/20 • Number of events 1 • 32 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Infections and infestations
Staphylococcal infection
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Psychiatric disorders
Suicide attempt
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/41 • 32 weeks
|
5.0%
1/20 • Number of events 1 • 32 weeks
|
Other adverse events
| Measure |
IXT-m200
n=41 participants at risk
Anti-methamphetamine monoclonal antibody, dose level of 1.5 g
IXT-m200: IXT-m200 binds METH with high selectivity and affinity. The product contains a murine METH-binding variable region and the constant domains of a human immunoglobulin G (IgG) 2κ. This antibody isotype was chosen because of the lower risk of immune response compared to an IgG1 or IgG3. IXT-m200 targets METH, does not rely on binding to any endogenous target for its action, and has been well-tolerated in previous clinical studies.
|
Placebo
n=20 participants at risk
Saline
Placebo: Saline
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
9.8%
4/41 • Number of events 4 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Infections and infestations
Tooth infection
|
7.3%
3/41 • Number of events 3 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Infections and infestations
Bacterial vaginosis
|
4.9%
2/41 • Number of events 2 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/41 • 32 weeks
|
5.0%
1/20 • Number of events 1 • 32 weeks
|
|
Infections and infestations
Herpes zoster
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Infections and infestations
Influenza
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Infections and infestations
Sinusitis
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Infections and infestations
Tooth abscess
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Infections and infestations
Trichomoniasis
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Infections and infestations
Vulvovainal mycotic infection
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/41 • 32 weeks
|
10.0%
2/20 • Number of events 2 • 32 weeks
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/41 • 32 weeks
|
5.0%
1/20 • Number of events 1 • 32 weeks
|
|
Psychiatric disorders
Drug abuse
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Psychiatric disorders
Irritability
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Investigations
Alanine aminotransferase increased
|
4.9%
2/41 • Number of events 2 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Investigations
Aspartate aminotransferase increase
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Investigations
Lipase increased
|
0.00%
0/41 • 32 weeks
|
5.0%
1/20 • Number of events 1 • 32 weeks
|
|
Investigations
Platelet count decreased
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Investigations
Weight increased
|
0.00%
0/41 • 32 weeks
|
5.0%
1/20 • Number of events 1 • 32 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
2/41 • Number of events 2 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
2/41 • Number of events 2 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/41 • 32 weeks
|
5.0%
1/20 • Number of events 1 • 32 weeks
|
|
Vascular disorders
Hypertension
|
7.3%
3/41 • Number of events 3 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Vascular disorders
Systolic hypertension
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Gastrointestinal disorders
Nausea
|
7.3%
3/41 • Number of events 3 • 32 weeks
|
5.0%
1/20 • Number of events 1 • 32 weeks
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
2/41 • Number of events 2 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
4.9%
2/41 • Number of events 2 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/41 • 32 weeks
|
5.0%
1/20 • Number of events 1 • 32 weeks
|
|
Nervous system disorders
Headache
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
5.0%
1/20 • Number of events 1 • 32 weeks
|
|
Nervous system disorders
Migraine with aura
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Eye disorders
Eye pruritus
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Eye disorders
Visual impairment
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
General disorders
Infusion site pain
|
0.00%
0/41 • 32 weeks
|
5.0%
1/20 • Number of events 1 • 32 weeks
|
|
General disorders
Non-cardiac chest pain
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
General disorders
Edema peripheral
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/41 • 32 weeks
|
5.0%
1/20 • Number of events 1 • 32 weeks
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
2.4%
1/41 • Number of events 1 • 32 weeks
|
0.00%
0/20 • 32 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor requires an opportunity to review any proposed disclosure at least 60 days prior to disclosure. Potential modifications may be suggested. PI will delete any information identified as confidential by sponsor or defer to permit filing of any patent applications. First publication will be a joint publication by Sponsor involving all trial sites. PI may publish if joint manuscript not submitted within 12 months of completion of clinical study report or termination of the trial at all sites.
- Publication restrictions are in place
Restriction type: OTHER