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NCT07221669Not yet recruitingPhase 3

A Study to Learn About Salanersen’s (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years With Spinal Muscular Atrophy (SMA) Who Are Either New to SMA Treatment or Were Previously Treated With Risdiplam (SOLAR)

An Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Salanersen (BIIB115) in Participants Aged 15-60 Years With Spinal Muscular Atrophy Who Are Either Treatment-Naïve or Have Previously Been Treated With Risdiplam

Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Nov 2026

Brief summary (registry, in English)

The primary objective of the SOLAR study is to evaluate the clinical efficacy of salanersen in participants with SMA who are treatment-naïve or previously treated with risdiplam.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
40 (estimated)
First submitted
8 Apr 2026
Start date
22 Jul 2026
Lead sponsor
Biogen Idec Research Limited
NCT number
NCT07221669
EU CT number
2025-524054-34-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 40
  • 14 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Hospitalization for surgery, a pulmonary event, or nutritional support within 2 months prior to Screening or plans to undergo elective procedures or surgeries at any time after signing the Informed Consent Form (ICF) through the end of the study. Note: If prior scoliosis surgery has been performed, it must be done at least 1 year prior to Screening.
  • Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 90 days or 5 half-lives of the treatment (if known), whichever is longer, prior to Screening. This includes neuromodulation therapy such as spinal cord stimulation.

Other illness

  • Respiratory insufficiency at Screening, defined by the medical necessity for invasive or noninvasive ventilation for > 6 hours during a 24-hour period (except for nocturnal bilevel positive airway pressure).
  • History of brain or spinal cord disease or other contraindications (e.g. severe scoliosis) that would interfere with the lumbar puncture (LP) procedures, Cerebrospinal fluid (CSF) circulation, efficacy assessments, or safety assessments (including a history of hydrocephalus or implanted shunt for CSF drainage), as assessed by the Investigator.
  • Presence of an active medical issue (e.g., infection, recent fracture) that would make the participant unsuitable for inclusion, as assessed by the Investigator.

Other

  • Medical necessity for a gastric feeding tube, where the majority of nutrition is provided by this route, as assessed by the site Investigator at Screening.

Who the study is looking for

  • Participants aged 15 to 60 years, inclusive, at the time of informed consent
  • For participants in the risdiplam-treated cohort: Willing to stop risdiplam therapy for the duration of the study. The last dose of risdiplam must be taken the day before the first dose of salanersen.
  • For participants in the risdiplam-treated cohort: No prior treatment with nusinersen, onasemnogene abeparvovec-xioi/onasemnogene abeparvovec-brve (OA), other approved DMTs for SMA or investigational drugs given for the treatment of SMA apart from risdiplam.
  • Ambulatory and nonambulatory participants. Ambulatory participants must be able to walk at least 10 meters independently without assistance and are willing and able to complete the 6 Minute Walk Test (6MWT) at Screening.
  • Participants with genetic documentation of 5q Spinal Muscular Atrophy (SMA) (homozygous gene deletion or mutation or compound heterozygous mutation).
  • Participants with clinical signs and symptoms consistent with SMA.
  • Survival motor neuron 2 (SMN2) copy number ≥ 1.
  • Participants with baseline Hammersmith Functional Motor Scale – Expanded (HFMSE) total score of ≥ 10 to ≤ 54.
  • Participants who are able to sit without using support for at least 10 seconds.
  • Participants with no prior treatment with myostatin inhibitors and a willingness to remain off concurrent myostatin inhibitor therapy for the duration of the study.
  • For participants in the treatment-naïve cohort: No prior treatment with an approved SMA Disease Modifying Therapy (DMT) or an investigational drug given for the treatment of SMA.
  • For participants in the risdiplam-treated cohort: Currently receiving risdiplam treatment and have been on once-daily 5 milligrams (mg) risdiplam treatment for at least 6 months prior to Screening.

Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitaetsklinikum Essen (AoR)
Coordinator of this site? Confirm its status
EssenGermanyNot yet recruiting
Universitaetsklinikum Heidelberg AöR
Coordinator of this site? Confirm its status
HeidelbergGermanyNot yet recruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyNot yet recruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainNot yet recruiting
Hospital Universitario La Paz
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MadridSpainNot yet recruiting
HUS-Yhtymae
Coordinator of this site? Confirm its status
HelsinkiFinlandNot yet recruiting
Assistance Publique Hopitaux De Paris
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GarchesFranceNot yet recruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceNot yet recruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceNot yet recruiting
Beaumont Hospital
Coordinator of this site? Confirm its status
Dublin 9IrelandNot yet recruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
Coordinator of this site? Confirm its status
MilanItalyNot yet recruiting
Centro Clinico Nemo
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MilanItalyNot yet recruiting
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Coordinator of this site? Confirm its status
CracowPolandNot yet recruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Coordinator of this site? Confirm its status
WarsawPolandNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.