ClinicalTrials.gg
TerminatedNCT05130866POPLAR-NF2Updated Aug 17, 2026

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

A Phase 2/3 interventional study of REC-2282 and Placebo in Neurofibromatosis Type 2, sponsored by Recursion Pharmaceuticals Inc.. Terminated at 15 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Recursion Pharmaceuticals Inc. · Phase 2/3, Interventional, and Treatment

Why this study was terminated
Study was terminated due to sponsor decision. This decision was not related to safety concerns with REC-2282.

From the registry’s dates

  • Primary completion was Aug 2025, 1 year 2 months ago, and no results have been posted to the registry; the sponsor requested a delay in submitting them in Aug 2026.
Phase
Phase 2/3
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Neurofibromatosis Type 2

Browse trials for

Keywords

  • Neurofibromatosis Type 2; Neurofibromatosis Type II
03

In context

Neurofibromatosis 2

47 studies on the registry are indexed under Neurofibromatosis 2; 10 are open to participants now.

This study's enrollment of 25 is above the median of 21 across 36 interventional studies indexed under Neurofibromatosis 2.

Browse Neurofibromatosis 2 studies →

Lead sponsor

Recursion Pharmaceuticals Inc. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. ≥12 years of age and weighing at least 40 kg
  2. Progressive meningioma that is amenable to volumetric analysis
  3. 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)
  4. Adequate bone marrow function
  5. Has provided written /assent to participate in the study

Exclusion criteria

Exclusion Criteria:

  1. Progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months.
  2. 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.
  3. Received an anti- tumor agent for meningioma within 3 months, or 5 half-lives (whichever is longer), prior to screening.
  4. History of an active 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.
  5. Received another drug within 30 days prior to screening
  6. 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Cohort A Adults, REC-2282 40 mg

    Adult participants will receive REC-2282.

    Drug: REC-2282

  • Experimental
    Cohort A Adults, REC-2282 60 mg

    Adult participants will receive REC-2282.

    Drug: REC-2282

  • Experimental
    Cohort A Adolescents, REC-2282

    Adolescent participants will receive REC-2282.

    Drug: REC-2282

  • Experimental
    Cohort B REC-2282

    Participants will receive REC-2282.

    Drug: REC-2282

  • Placebo comparator
    Cohort B Placebo

    Participants will receive placebo.

    Drug: Placebo

Interventions

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

    Also known as: AR-42, OSU-HDAC42, NSC-D736012

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: Up to 3 years

Secondary outcomes

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

    Time frame: 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.

    Time frame: 12 and 24 Months

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

    Time frame: Up to 3 years

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

    Time frame: Up to 3 years

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

    Time frame: Up to 3 years

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

    Time frame: Up to 3 years

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

    Time frame: Up to 3 years

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

    Time frame: Up to 3 years

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

    Time frame: Up to 3 years

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

    Time frame: Predose to 24 hours postdose

07

Study locations

15 sites
  • House Institute
    Los Angeles, California 90057, United States
  • University of California Los Angeles
    Los Angeles, California 90095, United States
  • Children's National Hospital
    Washington D.C., District of Columbia 20010, United States
  • University of Florida
    Gainesville, Florida 32611, United States
  • Nicklaus Children's Hospital
    Miami, Florida 33155, United States
  • Sarah Cannon Cancer Institute - HCA Midwest
    Overland Park, Kansas 66211, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • University of Minnesota / Masonic Cancer Center
    Minneapolis, Minnesota 55455, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Columbia University
    New York, New York 10032, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • UT Southwestern Medical Center
    Dallas, Texas 75390, United States
  • Northern Care Alliance NHS Foundation Trust
    Salford, M6 8HD, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05130866
Lead sponsor
Recursion Pharmaceuticals Inc.
Responsible party
Sponsor
First posted
Nov 23, 2021
Start date
Jun 20, 2022
Primary completion
Aug 18, 2025
Completion
Aug 18, 2025
Last update
Aug 17, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: REC-2282

Start the discussion