NCT03929497 is a Phase 2 clinical trial of Lu AF11167 in Schizophrenia, sponsored by H. Lundbeck A/S.

Who is sponsoring NCT03929497?

NCT03929497 is sponsored by H. Lundbeck A/S.

What drugs are being tested in NCT03929497?

Interventions in NCT03929497: Lu AF11167.

What condition does NCT03929497 study?

NCT03929497 studies Schizophrenia.

Is NCT03929497 still recruiting?

NCT03929497 is currently terminated. Last updated 23 September 2020.

Last reviewed 2020-09-23 · How we verify

NCT03929497

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms

Terminated Phase 2 Last updated 23 September 2020

What this trial tests

Phase 2 trial testing Lu AF11167 in Schizophrenia in 96 participants. Terminated before completion.

Timeline

22 April 2019

Primary endpoint
1 September 2020

14 September 2020

Quick facts

Lead sponsor	H. Lundbeck A/S
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	96
Start date	22 April 2019
Primary completion	1 September 2020
Estimated completion	14 September 2020
Sites	30 locations across Ukraine, Estonia, Germany, Hungary, Poland, Bulgaria, Latvia

Drugs / interventions tested

Lu AF11167 — full drug profile →

Conditions studied

Schizophrenia — all drugs for Schizophrenia →

Sponsor

H. Lundbeck A/S — full company profile →

Who can join

18 and older, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A study to evaluate the long-term safety and tolerability of flexible doses of Lu AF11167 in patients with schizophrenia during the 24-week treatment period

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

A double-blind, randomized, placebo-controlled proof of concept study of the efficacy and safety of Lu AF11167 for persistent negative symptoms in people with schizophrenia.
Meyer-Lindenberg A, Nielsen J, Such P, Lemming OM, et al · · 2022 · cited 11× · PMID 35704951 · DOI 10.1016/j.euroneuro.2022.05.009
Overview of Novel Antipsychotic Drugs: State of the Art, New Mechanisms, and Clinical Aspects of Promising Compounds.
Biso L, Carli M, Scarselli M, Longoni B. · · 2025 · cited 8× · PMID 39857669 · DOI 10.3390/biomedicines13010085
Progress in mechanistically novel treatments for schizophrenia.
Neef J, Palacios DS. · · 2021 · cited 5× · PMID 34671731 · DOI 10.1039/d1md00096a

Verify or expand the search:

Other trials of Lu AF11167

Trials testing the same drug.

NCT04104503 — A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects · Phase 1 · completed

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting

Other H. Lundbeck A/S trials

Trials by the same sponsor.

NCT07514858 — A Trial Investigating Lu AF28996 in Adults With Parkinson's Disease Who Have Motor Fluctuations · Phase 2 · not yet recruiting
NCT07513441 — A Trial of Lu AF28996 in Participants With Parkinson's Disease (PD) · Phase 1 · not yet recruiting
NCT06701526 — A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications · Phase 4 · active not recruiting
NCT06706622 — A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA) · Phase 3 · active not recruiting
NCT06557850 — A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease · Phase 1 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03929497 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by H. Lundbeck A/S
Last refreshed: 23 September 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03929497.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing