An Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3705 in Participants Previously Enrolled in Other Clinical Studies of mRNA-3705

Part of paid clinical trials in Los Angeles, California.

Sponsor
ModernaTX, Inc.
Study ID
NCT05295433
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Methylmalonic Acidemia

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • mRNA-3705 — DRUG
    A sterile liquid for injection

Study Details

The primary objective of this study is to evaluate the long-term safety and clinical activity of mRNA-3705 administered to participants with isolated methylmalonic acidemia (MMA) due to methylmalonyl-coenzyme A mutase (MUT) deficiency who have previously participated in other clinical studies of mRNA-3705.

Key Dates

Start date
Mar 8, 2022
Status verified
Nov 2025
Primary completion
Apr 2, 2034
Completion
Apr 2, 2034

Study Design

Enrollment
56 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: mRNA-3705
    Participants will receive mRNA-3705 at the same dose levels at the same dosing interval (every 2 weeks \[Q2W\], or every 3 weeks \[Q3W\]) last received in the clinical study of mRNA-3705 in which they initially participated, unless the Sponsor recommends modification.

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Drug-Related TEAEs, Unrelated TEAEs, Adverse Events of Special Interests (AESIs), Serious Adverse Events (SAEs) and TEAEs Leading to Discontinuation [ Time Frame: Baseline up to follow-up period (up to 6 years + 6 months) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UCLA Medical CenterLos AngelesCalifornia90095
Monserrath Campos
[email protected]
Lucile Packard Children's Hospital at StanfordPalo AltoCalifornia94304
Altman Clinical and Translational Research InstitutionSan DiegoCalifornia92037
Nicolle Mendez
[email protected]

Find similar trials in Los Angeles, CA

By research site
UCLA Medical Center· Los Angeles, CALucile Packard Children's Hospital at Stanford· Palo Alto, CAAltman Clinical and Translational Research Institution· San Diego, CA

Related Studies