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Neurofibromatosis Type 2Phase 2/3POPLAR-NF2NCT05130866

Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas

A Phase 2/3 study testing REC-2282 in people with Neurofibromatosis Type 2, run by Recursion Pharmaceuticals Inc. at 15 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a two-staged, Phase 2/3, randomized, multi-center study to investigate the efficacy and safety of REC-2282 in participants with progressive NF2 mutated meningiomas. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Neurofibromatosis Type 2
What is being tested?
REC-2282
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
15 sitesin 2 countries
Study dates
20 Jun 2022to 18 Aug 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • ≥12 years of age and weighing at least 40 kg
  • Progressive meningioma that is amenable to volumetric analysis
  • Has either 1) sporadic meningioma with confirmed NF2 mutation; or, 2) confirmed diagnosis of NF2 disease (revised Manchester criteria); or, 3) at least one NF2-related tumor (with pathogenic germline or proven mosaic NF2 variant)
  • Adequate bone marrow function
  • Has provided written informed consent/assent to participate in the study

Who cannot join

  • Progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months.
  • Received prior surgery, radiosurgery, or laser interstitial thermal therapy in the target tumor, or immediately adjacent to the target tumor within 12 months prior to screening.
  • Received an anti- tumor agent for meningioma within 3 months, or 5 half-lives (whichever is longer), prior to screening.
  • History of an active malignancy within the previous 3 years except for localized cancers that are considered cured, and, in the opinion of the investigator, present a low risk of recurrence.
  • Received another investigational drug within 30 days prior to screening
  • Pregnant, lactating, or is planning to attempt to become pregnant or impregnate someone during this study or within 90 days after the last dosing cycle.

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

United States14 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of Florida

    Gainesville, Florida, 32611

  • House Institute

    Los Angeles, California, 90057

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Nicklaus Children's Hospital

    Miami, Florida, 33155

  • University of Minnesota / Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Columbia University

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Sarah Cannon Cancer Institute - HCA Midwest

    Overland Park, Kansas, 66211

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Children's National Hospital

    Washington D.C., District of Columbia, 20010

Other trials in United States

United Kingdom1 site

  • Northern Care Alliance NHS Foundation Trust

    Salford, M6 8HD

Other trials in United Kingdom

About this study

Official title: A Two-staged, Phase 2/3, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of REC-2282 in Participants With Progressive NF2 Mutated Meningiomas

This is a two-staged, Phase 2/3, randomized, multi-center study to investigate the efficacy and safety of REC-2282 in participants with progressive NF2 mutated meningiomas.

Read the detailed description

Cohort A (Phase 2) will provide early data on efficacy and safety of REC-2282 in participants with progressive NF2 mutated meningiomas, and provide guidance for the dose in the confirmatory part of the study (Cohort B, Phase 3). The purpose of Cohort B of the study is to assess the efficacy and safety of REC-2282 compared with placebo in participants with progressive NF2 mutated meningiomas.

In both cohorts, there will be a screening period of up to 8 weeks, a treatment period, a 4-week safety follow-up period after the end of treatment, and a 6-month post-study follow-up. The first 8 participants enrolled in Cohort A will complete a food effect run-in sub study. At the end of the study period, participants may be offered participation in an open-label extension (OLE) period.

In Cohort A, adult participants will be randomized to one of two dose levels of REC-2282.

In Cohort B, participants will be randomized to REC-2282 treatment (dose to be determined from Cohort A) arm or placebo arm in a ratio of 2:1.

Being tested
REC-2282, Placebo
Keywords
Neurofibromatosis Type 2; Neurofibromatosis Type II
Medical subject headings
Neurofibromatosis 2

What participants receive

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

  • REC-2282Drug

    Also called AR-42, OSU-HDAC42, NSC-D736012

    Participants will receive REC-2282 3 times per week orally for 3 weeks followed by 1 week off for a 4-week cycle.

  • PlaceboDrug

    Participants will receive placebo orally 3 times per week for 3 weeks followed by 1 week off for a 4-week cycle.

Study groups in NCT05130866
Study groupRoleWhat they receive
Cohort A Adults, REC-2282 40 mgExperimentalAdult participants will receive REC-2282.
Receives: Drug: REC-2282
Cohort A Adults, REC-2282 60 mgExperimentalAdult participants will receive REC-2282.
Receives: Drug: REC-2282
Cohort A Adolescents, REC-2282ExperimentalAdolescent participants will receive REC-2282.
Receives: Drug: REC-2282
Cohort B REC-2282ExperimentalParticipants will receive REC-2282.
Receives: Drug: REC-2282
Cohort B PlaceboPlacebo comparatorParticipants will receive placebo.
Receives: Drug: Placebo

What is being measured

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

  1. Cohort A: Number of Participants with Progression-free survival (PFS) at 6 Months

    In Cohort A, PFS is defined as the number of participants who are alive and progression-free at 6 months with progression defined as having an increase of 20% or more in the target tumor identified.

    Measured: 6 months

  2. Cohort B: Number of Participants with PFS up to 3 years

    In Cohort B, PFS is defined as the time from the date of randomization until disease progression or death from any cause, whichever occurs first.

    Measured: Up to 3 years

Secondary outcomes (10)

  1. Cohort A: Change from Baseline in Target Tumor Volume at 6 Months

    Measured: 6 months

  2. Cohort A: Number of Participants with PFS at 12 and 24 Months

    In Cohort A, PFS is defined as the number of participants who are alive and progression-free at 12 and 24 months with progression defined as having an increase of 20% or more in the target tumor identified.

    Measured: 12 and 24 Months

  3. Cohorts A and B: Objective Response Rate (ORR)

    Measured: Up to 3 years

  4. Cohorts A and B: Disease Control Rate (DCR)

    Measured: Up to 3 years

  5. Cohorts A and B: Time to Response (TTR)

    Measured: Up to 3 years

  6. Cohorts A and B: Duration of Response (DOR)

    Measured: Up to 3 years

  7. Cohorts A and B: Time to Surgery/radiation for Target Tumors

    Measured: Up to 3 years

  8. Cohorts A and B: Maximum Observed Plasma Concentration (Cmax) of REC-2282

    Measured: Up to 3 years

  9. Cohorts A and B: Time to Maximum Plasma Concentration (Tmax) of REC-2282

    Measured: Up to 3 years

  10. Cohorts A and B: Area under the curve from 0 to 24hr (AUC) of REC-2282

    Measured: Predose to 24 hours postdose

Timeline

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

  1. First posted23 Nov 2021
  2. Study start20 Jun 2022
  3. Primary completion18 Aug 2025
  4. Study completion18 Aug 2025

Why it stopped: Study was terminated due to sponsor decision. This decision was not related to safety concerns with REC-2282.

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A Two-staged, Phase 2/3, Randomized, Multicenter Efficacy and Safety Study.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05130866
Sponsor's protocol ID
REC-2282-201
Acronym
POPLAR-NF2
Status last verified
Oct 2025
First submitted
10 Nov 2021
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing REC-2282 in people with Neurofibromatosis Type 2, run by Recursion Pharmaceuticals Inc. at 15 sites in 2 countries.

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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, United Kingdom. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study was stopped early (reason given: Study was terminated due to sponsor decision. This decision was not related to safety concerns with REC-2282.). Results are not available in the source record.

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?

Cohort A: Number of Participants with Progression-free survival (PFS) at 6 Months (time frame: 6 months). The study lists 2 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 NCT05130866.

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 17 Aug 2026.

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