OUTLAST: Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200
Study Details
Study Description
Brief Summary
This Phase 2 study will evaluate the safety and efficacy of monthly intravenous doses of IXT-m200 in treatment-seeking individuals with methamphetamine (METH) use disorder. The hypothesis are that following an initial relapse, IXT-m200 will reduce the occurrence of stimulant-positive saliva samples compared to placebo and improve the signs and symptoms of METH Use Disorder (MUD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IXT-m200 Anti-methamphetamine monoclonal antibody, dose levels of 1.5 and 3 g |
Drug: 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 Comparator: Placebo Saline |
Other: Placebo
Saline
|
Outcome Measures
Primary Outcome Measures
- Percent of 20 weeks abstinent from stimulants following a 4-week grace period [20 weeks]
Saliva screens and by self-report
Secondary Outcome Measures
- Proportion of responders with reduced DSM-5 criteria at Week 25 as measured by DSM-5 criteria [25 weeks]
A responder is defined as a participant who meets a reduced number of DSM-5 criteria for MUD over the past month compared to Screening
- Proportion of responders in early remission at Week 25 as measured by DSM-5 criteria [25 weeks]
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.
- Complete abstinence during last month of study drug treatment [25 weeks]
Saliva screens and by self-report
- Difference between groups in Clinical Global Impression of Change (CGIC) at Week 13, 25, and 33 [33 weeks]
The CGIC asks clinicians to complete one statement with the result ranging from 1-7 with lower scores representing a better outcome.
- Difference between groups in Patient Global Impression of Change (PGIC) at Week 13, 25, and 33 [33 weeks]
The PGIC asks patients to complete one statement with the result ranging from 1-7 with lower scores representing a better outcome.
- Change from screening in participant-rated quality of life as measured by the Treatment Effectiveness Assessment [33 weeks]
Treatment Effectiveness Assessment (TEA) asks questions in four domains with results ranging from 4-40 with higher scores representing a better outcome.
- Number of treatment-related adverse events (AEs) as measured by physical examination [33 weeks]
Physical examinations
- Number of treatment-related AEs as measured by vital signs [33 weeks]
Blood pressure, heart rate, and temperature
- Number of treatment-related AEs as measured by ECG [33 weeks]
Electrocardiogram
- Number of treatment-related AEs as measured by clinical laboratory testing [33 weeks]
Clinical laboratory testing
- Number of participants with anti-IXT-m200 antibody levels that are confirmed positive and have titers more than three times the minimum required dilution [33 weeks]
Anti-IXT-m200 antibody levels
Other Outcome Measures
- Number of sequential weeks of abstinence from the end of treatment [25 weeks]
Saliva screens and by self-report
- Point prevalence abstinence (last 7 days) [33 weeks]
Saliva screens and by self-report
- Weekly abstinence from stimulants following a 4-week grace period [25 weeks]
Saliva screens
- Proportion of responders with reduced DSM-5 criteria at Week 33 as measured by DSM-5 criteria [33 weeks]
A responder is defined as a participant who meets a reduced number of DSM-5 criteria for MUD over the past month compared to Screening
- Proportion of responders in early remission at Week 33 as measured by DSM-5 criteria [33 weeks]
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.
Eligibility Criteria
Criteria
Eligible participants will:
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Be at least 18 years of age at the time of study consent;
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Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Substance Use Disorder associated with methamphetamine;
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Be treatment-seeking methamphetamine users with at least 1 methamphetamine or amphetamine positive specimen during the screening period;
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Be able and willing to read, comprehend, and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent;
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Be willing to comply with study instructions and dosing, agree to make all appointments, and complete the entire course of the study;
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Agree to use protocol-specified method(s) of birth control throughout study participation;
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Agree to adhere to Lifestyle Considerations throughout study duration;
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Have access to a smartphone or other device capable of supporting the study app;
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Successfully complete app-based training program as evidenced by completion of at least 75% of daily drug use surveys and assigned saliva drug screens (two of which must be valid) in ≤30 days from the screening visit during the screening period.
Eligible participants will NOT:
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Have current dependence, defined by DSM-5 criteria, on any psychoactive substance (i.e., opioids or benzodiazepines), other than methamphetamine or nicotine (any severity). Mild severity dependence on alcohol or marijuana is allowed;
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Be currently taking certain other drugs and medications, including: "designer drugs" (e.g., 3,4-methylenedioxyMETH (MDMA, Ecstasy, Adam, XTC) and its N-dimethyl metabolite methylenedioxyamphetamine (MDA), anti-orexigenic drugs (including over-the-counter medications for weight loss), or be chronic users of phenethylamine compounds (e.g., phenylpropanolamine, ephedrine, pseudoephedrine, amphetamine, phentermine, phenmetrazine, methylphenidate, diethylpropion, and propylhexedrine);
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Have a known contraindication or sensitivity to IXT-m200 based on known allergies to other monoclonal antibodies, any inactive ingredient of IXT-m200, or any other products required for the study procedures;
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Have a history of severe allergy (rash, hives, breathing difficulty, etc) to any medications;
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Have a history of allergic or environmental bronchial asthma within the past 3 years;
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Have a current diagnosis of anorexia nervosa or bulimia disorder;
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Have a history of unstable cardiovascular disease that is not adequately controlled at the time of eligibility determination;
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Be mandated by the court to obtain treatment for methamphetamine-dependence where such mandate required the results of methamphetamine testing to be reported to the court;
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Have positive saliva drug screens for psychoactive substances other than amphetamines at the screening visit;
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Be expected to fail to complete the study protocol due to probable incarceration or relocation from the clinic area, or any clinically significant mental or physical illness within a 1-year prior, that would impact compliance with trial requirements;
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Have clinically significant laboratory values (outside of normal limits). The following specified ranges are allowable:
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Liver function tests (total, direct, and indirect bilirubin, aspartate transaminase, alanine aminotransferase, gamma-glutamyl transferase, lactate dehydrogenase, and alkaline phosphatase) <3 times the upper limit of normal, and
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Kidney function tests (creatinine and BUN) <2 times the upper limit of normal;
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Be considered to be at imminent risk of suicide or have a past-year history of a serious suicide attempt (defined as an attempt that results in or requires medical treatment) based on response to queries within eligibility screening about suicidal ideation and attempts;
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Have an uncontrolled systemic disease or a medical condition that may increase the risk associated with study participation or administration of study treatment or that may interfere with the interpretation of study results;
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Be currently participating or has participated within the last 30 days prior to the start of this study in a drug, device, or other interventional research study;
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Be pregnant or lactating;
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In the Investigator's or Sponsor's (or designee) opinion, be inappropriate for the study, including those believed to be attempting to enter the study primarily for financial gain.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alea Research | Phoenix | Arizona | United States | 85012 |
| 2 | Pillar Clinical Research | Bentonville | Arkansas | United States | 72712 |
| 3 | Woodlands International Research Group | Little Rock | Arkansas | United States | 72211 |
| 4 | Artemis Institute for Clinical Research | San Diego | California | United States | 92103 |
| 5 | Pillar Clinical Research | Lincolnwood | Illinois | United States | 60712 |
| 6 | Altea Research Institute | Las Vegas | Nevada | United States | 89102 |
| 7 | Midwest Clinical Research Center | Dayton | Ohio | United States | 45417 |
| 8 | Pahl Pharmaceutical Professionals | Oklahoma City | Oklahoma | United States | 73112 |
| 9 | Pillar Clinical Research | Richardson | Texas | United States | 75080 |
Sponsors and Collaborators
- InterveXion Therapeutics, LLC
- National Institute on Drug Abuse (NIDA)
Investigators
- Study Director: Chief Medical Officer, InterveXion Therapeutics
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- M200C-2201
- U01DA055481