Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200

Methamphetamine Abuse Clinical Trial

— OUTLAST  

Official title:

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200 in Treatment-Seeking Individuals With Methamphetamine Use Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05034874
• Other study ID #: M200C-2201
• Secondary ID: U01DA055481
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 9, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: InterveXion Therapeutics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Eligible participants will:

1. Be at least 18 years of age at the time of study consent;

2. Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Substance Use Disorder associated with methamphetamine;

3. Be treatment-seeking methamphetamine users with at least 1 methamphetamine or amphetamine positive specimen during the screening period;

4. Be able and willing to read, comprehend, and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent;

5. Be willing to comply with study instructions and dosing, agree to make all appointments, and complete the entire course of the study;

6. Agree to use protocol-specified method(s) of birth control throughout study participation;

7. Agree to adhere to Lifestyle Considerations throughout study duration;

8. Have access to a smartphone or other device capable of supporting the study app;

9. 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:

1. 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;

2. 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);

3. 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;

4. Have a history of severe allergy (rash, hives, breathing difficulty, etc) to any medications;

5. Have a history of allergic or environmental bronchial asthma within the past 3 years;

6. Have a current diagnosis of anorexia nervosa or bulimia disorder;

7. Have a history of unstable cardiovascular disease that is not adequately controlled at the time of eligibility determination;

8. 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;

9. Have positive saliva drug screens for psychoactive substances other than amphetamines at the screening visit;

10. 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;

11. Have clinically significant laboratory values (outside of normal limits). The

following specified ranges are allowable:

1. 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

2. Kidney function tests (creatinine and BUN) <2 times the upper limit of normal;

12. 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;

13. 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;

14. 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;

15. Be pregnant or lactating;

16. 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.

Related Conditions & MeSH terms

• Methamphetamine Abuse
• Methamphetamine-dependence

Intervention

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) 2?. 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.

Other:
• Placebo
Saline

Locations

Country	Name	City	State
United States	Pillar Clinical Research	Bentonville	Arkansas
United States	Alpine Research	Clinton	Utah
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	InSite Clinical Research	DeSoto	Texas
United States	HD Research	Houston	Texas
United States	Pillar Clinical Research	Lincolnwood	Illinois
United States	Woodlands International Research Group	Little Rock	Arkansas
United States	Pillar Clinical Research	Richardson	Texas
United States	Artemis Institute for Clinical Research	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
InterveXion Therapeutics, LLC	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of sequential weeks of abstinence from the end of treatment	Saliva screens and by self-report	25 weeks
Other	Point prevalence abstinence (last 7 days)	Saliva screens and by self-report	33 weeks
Other	Weekly abstinence from stimulants following a 4-week grace period	Saliva screens	25 weeks
Other	Proportion of responders with reduced DSM-5 criteria at Week 33 as measured by DSM-5 criteria	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	33 weeks
Other	Proportion of responders in early remission at Week 33 as measured by DSM-5 criteria	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.	33 weeks
Primary	Percent of 20 weeks abstinent from stimulants following a 4-week grace period	Saliva screens and by self-report	20 weeks
Secondary	Proportion of responders with reduced DSM-5 criteria at Week 25 as measured by DSM-5 criteria	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	25 weeks
Secondary	Proportion of responders in early remission at Week 25 as measured by DSM-5 criteria	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.	25 weeks
Secondary	Complete abstinence during last month of study drug treatment	Saliva screens and by self-report	25 weeks
Secondary	Difference between groups in Clinical Global Impression of Change (CGIC) at Week 13, 25, and 33	The CGIC asks clinicians to complete one statement with the result ranging from 1-7 with lower scores representing a better outcome.	33 weeks
Secondary	Difference between groups in Patient Global Impression of Change (PGIC) at Week 13, 25, and 33	The PGIC asks patients to complete one statement with the result ranging from 1-7 with lower scores representing a better outcome.	33 weeks
Secondary	Change from screening in participant-rated quality of life as measured by the Treatment Effectiveness Assessment	Treatment Effectiveness Assessment (TEA) asks questions in four domains with results ranging from 4-40 with higher scores representing a better outcome.	33 weeks
Secondary	Number of treatment-related adverse events (AEs) as measured by physical examination	Physical examinations	33 weeks
Secondary	Number of treatment-related AEs as measured by vital signs	Blood pressure, heart rate, and temperature	33 weeks
Secondary	Number of treatment-related AEs as measured by ECG	Electrocardiogram	33 weeks
Secondary	Number of treatment-related AEs as measured by clinical laboratory testing	Clinical laboratory testing	33 weeks
Secondary	Number of participants with anti-IXT-m200 antibody levels that are confirmed positive and have titers more than three times the minimum required dilution	Anti-IXT-m200 antibody levels	33 weeks