Amyotrophic Lateral SclerosisPhase 2NCT05163886

Study of Safety, Tolerability, and Biological Activity of LAM-002A in C9ORF72-Associated Amyotrophic Lateral Sclerosis

A Phase 2 study testing LAM-002A in people with Amyotrophic Lateral Sclerosis and ALS, run by IRulya Therapeutics Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a clinical trial to evaluate the safety, tolerability, and biological effect of LAM-002A in adults with C9ORF72-associated ALS (C9ALS). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Amyotrophic Lateral Sclerosis, ALS
What is being tested?: LAM-002A
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 3 sitesUnited States
Study dates: 23 Dec 2021to 31 May 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of C9ORF72-associated ALS with BOTH of the following:
Documentation of a clinical genetic test demonstrating the presence of a pathogenic repeat expansion in C9ORF72. If there is a strong clinical suspicion for C9ALS based on C9-positive family history and El Escorial Criteria consistent with a diagnosis of ALS, clinical testing for the C9ORF72 repeat expansion may be performed with study screening labs at the discretion of the Site Investigator (SI), medical monitor, and study sponsor.
AND
Must meet possible, laboratory-supported probable, probable, or definite criteria for diagnosing ALS by revised El Escorial criteria (Brooks 2000).
Age 18 or older
Capable of providing informed consent at the Screening Visit and complying with study procedures throughout the study, in the SI's opinion, and at the discretion of the medical monitor and study sponsor.

Show all 13Show fewer

In the case that a participant lacks the ability to provide informed consent. Informed consent will be sought from the participant's surrogate representative.
Able to safely swallow study drug capsule at screening and throughout study. May use thickened substances to assist in swallowing drug.
Vital Capacity greater than and equal to 50% of predicted at the time of the Screening Visit measured by Slow Vital Capacity (SVC), or, if required due to COVID-19 pandemic-related restrictions and with Sponsor approval, Forced Vital Capacity (FVC) measured in-person or via telemedicine.
Participants must either not take or be on a stable dose of riluzole (as either a tablet or oral suspension) for greater than 30 days prior to the Screening Visit. Riluzole-naïve participants are permitted in the study.
Participants must either not take edaravone or have completed at least one 14-day cycle with plan for continuation of edaravone prior to the Screening Visit. Participants must be off cycle and at least 2 days after the last dose administration of edaravone at the time of study visit. Edaravone-naïve participants are permitted in the study.
Participants must be able to complete all study procedures, including the lumbar punctures (LP) at the time of the Screening Visit, in the SI's opinion.
Geographically accessible to the site.

Who cannot join

Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to the SI's judgment [e.g., cardiovascular instability, systemic infection, or clinically significant laboratory abnormality or electrocardiogram (ECG) changes].
Gastrointestinal disease (e.g., gastric, or intestinal bypass surgery, jejunostomy tube, pancreatic enzyme insufficiency, malabsorption syndrome, symptomatic inflammatory bowel disease, chronic diarrheal illness, bowel obstruction) that might interfere with drug absorption or with interpretation of gastrointestinal AEs. Gastrostomy tube placement is allowed prophylactically or to supplement nutrition/hydration but may not be used for study drug administration.
Hepatic profile showing any of the following:
Serum alanine aminotransferase (ALT) greater than 5 × upper limit of normal (ULN).
Serum aspartate aminotransferase (AST) greater than 5 × ULN.
Serum bilirubin greater than 1.5 × ULN.

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Renal profile showing an estimated creatinine clearance (eClCR) less than 30 mL/minute (with eClCR to be calculated by the method at the laboratory performing the serum creatinine test).
Presence of a neurodegenerative cognitive or motor syndrome (e.g., Alzheimer's disease, Parkinson's disease) not related to the C9ORF72 repeat expansion.
Presence of unstable psychiatric disease or substance abuse that would impair ability of the participant to provide informed consent, in the SI's opinion.
Active cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years. Active cancer includes cancers with current disease manifestations or therapy that could adversely affect subject safety and longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.
Prior solid organ transplantation.
Ongoing immunosuppressive therapy including systemic or enteric corticosteroids at screening or for the duration of the trial, at the discretion of the site investigator and medical monitor.
Use within 5 days prior to randomization or for the duration of the trial of a strong inhibitor or inducer of cytochrome P450 (CYP) 3A4 or expected requirement for chronic use of a strong inhibitor or inducer of CYP3A4 during study therapy.
Use within 5 days prior to randomization or for the duration of the trial of drug that is a moderate-to-strong substrate of CYP2C9 (including warfarin, tolbutamide, phenytoin, glimepiride) or expected requirement for chronic use of such drugs during study therapy, at the discretion of the site investigator and medical monitor.
Use of investigational treatments for ALS (off-label use or active participation in a clinical trial) within 5 half-lives (if known) or 30 days (whichever is longer) prior to the Screening Visit.
Exposure at any time to any gene therapies under investigation for the treatment of ALS (off-label use or investigational).
If female, breastfeeding, known to be pregnant, planning to become pregnant during the study, or of child-bearing potential and unwilling to use effective contraception for the duration of the trial and for 3 months after discontinuing treatment.
If male of reproductive capacity, unwilling to use effective contraception for the duration of the trial and for 3 months after discontinuing study treatment.
Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study, in the SI's opinion.
If a participant is being re-screened, the disqualifying condition has not been resolved, or the mandatory wash-out duration has not occurred.
Contraindication to undergoing a lumbar puncture (LP) in the SI's opinion. Participants undergoing the LP must not be currently taking anticoagulation and antiplatelet medications such as warfarin and clopidogrel bisulfate (Plavix™), that would be a contraindication to LP; aspirin and non-steroidal anti-inflammatories are allowed.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: A Phase IIa Trial to Evaluate the Safety, Tolerability, and Biological Activity of LAM-002A (Apilimod Dimesylate Capsules) in C9ORF72-Associated Amyotrophic Lateral Sclerosis

This is a clinical trial to evaluate the safety, tolerability, and biological effect of LAM-002A in adults with C9ORF72-associated ALS (C9ALS).

Read the detailed description

This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, biomarker-driven clinical trial evaluating the safety, tolerability, and biological effect of LAM-002A in approximately 12 adults with C9ORF72-associated ALS (C9ALS).

In Part A of the study, approximately twelve C9ALS participants will receive either standard of care plus LAM-002A or standard of care and placebo (randomized 2:1) for the first 12 weeks of the study (Core Study). LAM-002A will be administered as oral capsules 125 mg BID (250 mg total daily dose). The LAM-002A dose may be reduced to 100 mg BID (200 mg total daily dose) if expected gastrointestinal side effects develop.

Participants who complete the first 12 weeks of the Core Study will be eligible to receive active drug (LAM-002A capsules at maximum tolerated dose of 125 or 100 mg BID) for the remainder of the study (open-label extension [OLE]) up to Week 24.

In Part B of the study, participants who complete Part A Week 24 on study drug, will be offered the opportunity to opt-in to continue the open label extension for additional 36 weeks starting at the week 24 visit. Participants who elect not to roll over into the Treatment period B will complete the Day 168 visit, followed a final safety telephone call visit at week 28 to complete study participation. Participants who opt-in to the open label extension for an additional 36 weeks will have their end of study safety telephone call at week 64.

Conditions: Amyotrophic Lateral Sclerosis, ALS
Being tested: LAM-002A, Placebo
Keywords: C9ORF72
Medical subject headings: Amyotrophic Lateral Sclerosis, Frontotemporal Dementia With Motor Neuron Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LAM-002ADrug
LAM-002A (apilimod dimesylate) is formulated in capsules containing 25 mg of apilimod dimesylate. The capsule is Swedish orange, size 0.
PlaceboOther
Microcrystalline cellulose in Swedish orange, size 0 capsules.

Study groups in NCT05163886
Study group	Role	What they receive
LAM-002A	Experimental	LAM-002A will be administered orally in five 25 mg capsules twice a day (250 mg total daily dose). Receives: Drug: LAM-002A
Placebo	Placebo comparator	Placebo matching LAM-002A will be administered orally in 5 capsules twice a day. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety of LAM-002A: Occurrence of TEAEs and SAEs
Number of Participants with Treatment-Related Adverse Events (TEAEs) and Serious Adverse Events
Measured: 24 Weeks
Tolerability of LAM-002A: Completion of Core Study Treatment
The percentage of participants who complete 12 weeks on study treatment during the Core Study.
Measured: 12 Weeks
Plasma Pharmacokinetics of LAM-002A and Major Metabolites
The concentration of LAM-002A and its major metabolites (STA-5908, STA-5944, and STA-6048) in plasma.
Measured: 24 Weeks
CSF Pharmacokinetics of LAM-002A and Major Metabolites
The concentration of LAM-002A and its major metabolites (STA-5908, STA-5944, and STA-6048) cerebral spinal fluid (CSF).
Measured: 24 Weeks

Secondary outcomes (3)

Changes in Plasma Level of sGPNMB
Changes in plasma levels of the LAM-002A-induced biomarker, soluble glycoprotein nonmetastatic melanoma protein B (sGPNMB)
Measured: 12 Weeks
Changes in CSF Level of sGPNMB
Changes in cerebrospinal fluid (CSF) levels of the LAM-002A-induced biomarker, soluble glycoprotein nonmetastatic melanoma protein B (sGPNMB)
Measured: 12 Weeks
Tolerability of LAM-002A: Completion of Open-label Study Treatment
Secondary measures of tolerability will consider completion of 12 weeks on open-label study treatment during the OLE through study Week 24.
Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Dec 202131 May 2025

First posted20 Dec 2021
Study start23 Dec 2021
Primary completion11 Jan 2023
Study completion31 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Double-blind, placebo-controlled
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05163886
Sponsor's protocol ID: LAM-002A-ALS-CLN01
Status last verified: Sep 2026
First submitted: 17 Nov 2021
Last updated: 29 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Babu S, Nicholson KA, Rothstein JD, Swenson A, Sampognaro PJ, Pant P, Macklin EA, Spruill S, Paganoni S, Gendron TF, Prudencio M, Petrucelli L, Nix D, Landrette S, Nkrumah E, Fandrick K, Edwards J, Young PR. Apilimod dimesylate in C9orf72 amyotrophic lateral sclerosis: a randomized phase 2a clinical trial. Brain. 2024 Sep 3;147(9):2998-3008. doi: 10.1093/brain/awae109.
PubMed 38606777

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa Trial to Evaluate the Safety, Tolerability, and Biological Activity of LAM-002A (Apilimod Dimesylate Capsules) in C9ORF72-Associated Amyotrophic Lateral Sclerosis
ClinicalTrials.gov ID: NCT05163886
Acronym / sponsor ID: LAM-002A-ALS-CLN01
Conditions: Amyotrophic Lateral Sclerosis, ALS
Keywords: C9ORF72
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: IRulya Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: 23 Dec 2021 (actual)
Primary completion: 11 Jan 2023 (actual)
Study completion: 31 May 2025 (actual)
First posted: 20 Dec 2021 (actual)
Results: Posted 29 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a clinical trial to evaluate the safety, tolerability, and biological effect of LAM-002A in adults with C9ORF72-associated ALS (C9ALS).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Double-blind, placebo-controlled

Arm	Type	Receives
LAM-002A	Experimental	Drug: LAM-002ALAM-002A will be administered orally in five 25 mg capsules twice a day (250 mg total daily dose).
Placebo	Placebo comparator	Other: PlaceboPlacebo matching LAM-002A will be administered orally in 5 capsules twice a day.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Diagnosis of C9ORF72-associated ALS with BOTH of the following:
AND
Age 18 or older
Capable of providing informed consent at the Screening Visit and complying with study procedures throughout the study, in the SI's opinion, and at the discretion of the medical monitor and study sponsor.
In the case that a participant lacks the ability to provide informed consent. Informed consent will be sought from the participant's surrogate representative.

Key exclusion criteria (21 listed)

Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to the SI's judgment [e.g., cardiovascular instability, systemic infection, or clinically significant laboratory abnormality or electrocardiogram (ECG) changes].
Presence of a neurodegenerative cognitive or motor syndrome (e.g., Alzheimer's disease, Parkinson's disease) not related to the C9ORF72 repeat expansion.
Presence of unstable psychiatric disease or substance abuse that would impair ability of the participant to provide informed consent, in the SI's opinion.
Active cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years. Active cancer includes cancers with current disease manifestations or therapy that could adversely affect subject safety and longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.
Prior solid organ transplantation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LAM-002ALAM-002A (apilimod dimesylate) is formulated in capsules containing 25 mg of apilimod dimesylate. The capsule is Swedish orange, size 0.	Drug	LAM-002A
PlaceboMicrocrystalline cellulose in Swedish orange, size 0 capsules.	Other	Placebo

Primary outcome

Safety of LAM-002A: Occurrence of TEAEs and SAEs
Time frame: 24 Weeks
Number of Participants with Treatment-Related Adverse Events (TEAEs) and Serious Adverse Events
Tolerability of LAM-002A: Completion of Core Study Treatment
Time frame: 12 Weeks
The percentage of participants who complete 12 weeks on study treatment during the Core Study.
Plasma Pharmacokinetics of LAM-002A and Major Metabolites
Time frame: 24 Weeks
The concentration of LAM-002A and its major metabolites (STA-5908, STA-5944, and STA-6048) in plasma.
CSF Pharmacokinetics of LAM-002A and Major Metabolites
Time frame: 24 Weeks
The concentration of LAM-002A and its major metabolites (STA-5908, STA-5944, and STA-6048) cerebral spinal fluid (CSF).

3 secondary outcomes

Changes in Plasma Level of sGPNMB
Time frame: 12 Weeks
Changes in CSF Level of sGPNMB
Time frame: 12 Weeks
Tolerability of LAM-002A: Completion of Open-label Study Treatment
Time frame: 24 Weeks

Results and safety

Results posted to the registry on 29 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LAM-002A Weeks 1-24 and OLE (Part B and Part C)	10	8
Placebo Weeks 1-12 and LAM-002A Weeks 12-24 and OLE (Part B and Part C)	5	3

Primary outcome: Safety of LAM-002A: Occurrence of TEAEs and SAEs

Time frame: 24 Weeks. Count of participants. Unit: Participants

Measure	LAM-002A Weeks 1-24 n = 10	Placebo Weeks 1-12 n = 5	LAM-002A Weeks 12-24 n = 5
Treatment Emergent Adverse Events (TEAEs)	10	3	5
Serious Adverse Events (SAEs)	1	0	1

Population analysed: As Treated Population includes all enrolled participants who received at least one dose of study drug. Placebo participants Week 1-12 and Week 12-24 are the same participants separated by treatment received.

Primary outcome: Tolerability of LAM-002A: Completion of Core Study Treatment

Time frame: 12 Weeks. Count of participants. Unit: Participants

Measure	LAM-002A Weeks 1-24 n = 10	Placebo Weeks 1-12 n = 5
Value	9	5

Population analysed: As Treated Population includes all enrolled participants who received at least one dose of study drug.

Primary outcome: Plasma Pharmacokinetics of LAM-002A and Major Metabolites

Time frame: 24 Weeks. Mean (Standard Deviation). Unit: ng/mL

Measure	LAM-002A Weeks 1-24 n = 10	Placebo Weeks 1-12 and LAM-002A Weeks 12-24 n = 5
LAM-002A Baseline (predose)	0.10 (0.000)	0.10 (0.000)
LAM-002A Week 2 (1 hour post dose)	269.73 (196.302)	0.10 (0.000)
LAM-002A Week 4 (1 hour post dose)	213.80 (122.041)	0.10 (0.000)
LAM-002A Week 8 (1 hour post dose)	344.10 (184.700)	0.18 (0.173)
LAM-002A Week 12 (1 hour post dose)	283.13 (135.198)	172.64 (149.986)
LAM-002A Week 24 (1 hour post dose)	315.40 (131.386)	153.83 (118.791)
STA-5908 Baseline (predose)	0.10 (0.000)	0.10 (0.000)
STA-5908 Week 2 (1 hour post dose)	188.02 (136.417)	0.10 (0.000)

Population analysed: Participants who had sufficient PK concentration data to be meaningfully included in the PK analysis summaries. Participants in the Placebo group could start LAM-002A treatment from Week 12 onward.

Primary outcome: CSF Pharmacokinetics of LAM-002A and Major Metabolites

Time frame: 24 Weeks. Mean (Standard Deviation). Unit: ng/mL

Measure	LAM-002A Weeks 1-24 n = 10	Placebo Weeks 1-12 and LAM-002A Weeks 12-24 n = 5
LAM-002A Baseline (predose)	0.01 (0.000)	0.01 (0.000)
LAM-002A Week 4 (1 hour post dose)	1.50 (0.901)	0.01 (0.000)
LAM-002A Week 8 (1 hour post dose)	1.96 (1.159)	0.01 (0.000)
LAM-002A Week 12 (1 hour post dose)	1.63 (0.937)	1.03 (1.024)
LAM-002A Week 24 (1 hour post dose)	2.58 (2.000)	1.81 (1.709)
STA-5908 Baseline (predose)	0.01 (0.000)	0.01 (0.000)
STA-5908 Week 4 (1 hour post dose)	1.39 (1.134)	0.01 (0.000)
STA-5908 Week 8 (1 hour post dose)	1.98 (1.484)	0.01 (0.000)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline through Week 24. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LAM-002A Weeks 1-24	1 of 10 (10%)	10 of 10 (100%)	0 of 10
Placebo Weeks 1-12	0 of 5 (0%)	3 of 5 (60%)	0 of 5
LAM-002A Weeks 12-24	1 of 5 (20%)	5 of 5 (100%)	1 of 5

Limitations and caveats (from the sponsor): Part A (placebo-controlled through Week 12 and open label through Week 24) and B (open label extension) of the study was completed after all participants reached ≥24 weeks of study drug administration to allow the participants to begin treatment with Relyvrio, a drug that had recently been approved by the FDA. Participants still on study were eligible to be reconsented to Part C (open label extension) if they did not want to begin Relyviro treatment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38606777Babu S, Nicholson KA, Rothstein JD, Swenson A, Sampognaro PJ, Pant P, Macklin EA, Spruill S, Paganoni S, Gendron TF, Prudencio M, Petrucelli L, Nix D, Landrette S, Nkrumah E, Fandrick K, Edwards J, Young PR. Apilimod dimesylate in C9orf72 amyotrophic lateral sclerosis: a randomized phase 2a clinical trial. Brain. 2024 Sep 3;147(9):2998-3008. doi: 10.1093/brain/awae109.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Suma Babu, M.D. principal investigator

Massachusetts General Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LAM-002A in people with Amyotrophic Lateral Sclerosis and ALS, run by IRulya Therapeutics Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of LAM-002A: Occurrence of TEAEs and SAEs (time frame: 24 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05163886, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.