Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands

NCT03967249 on ClinicalTrials.gov Phase 2 Ionis Pharmaceuticals, Inc. (industry) Started 2019-07-25 Completed

Riskier than 36% of active trials

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 19% of the time (731 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2022-07-07, after 2019-07-25 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2022-07-07. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Sponsor's past termination rate: 4.3% (lowers risk) · Sponsor's track record
Disease area, neurology: Yes (raises risk) · Disease area
Design: single group (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: completedextensionpurposelongcompletion of
Phrases that lowered it: participanttrialvisitactingscreening
Drug's FAERS reports with a death: 19.5% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: 69.8% (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Trials the sponsor started in the prior 2 years: 11 (raises risk) · Sponsor's track record
Sponsor's past trials: 46 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Blinding: none (raises risk) · Design
Maximum age: 75 (lowers risk) · Who can join
Number of arms: 1 (raises risk) · Design

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 2
Number of arms: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 1

Who can join

Minimum age: 18
Maximum age: 75 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 46 (typical: 32)
Sponsor's past termination rate: 4.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 11 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 21303 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 4233 (typical: 412.5)
Drug's FAERS reports marked serious: 69.8% (typical: 85.6%)
Drug's FAERS reports with a death: 19.5% (typical: 15.9%)

Disease area and drugs

Disease areas: neurology, musculoskeletal, endocrine
Drugs matched to FDA substances: lanreotide, octreotide, somatostatin

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands NCT03548415 · started 2018 · scored riskier than 53% of active trials completed
A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly NCT04522180 · started 2021 · scored riskier than 38% of active trials completed
A Clinical Trial to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Octreotide Long-acting Injection in Patients With Acromegaly NCT07814651 · started 2024 · scored riskier than 36% of active trials completed
Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly NCT02493517 · started 2014 · scored riskier than 51% of active trials completed
Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly NCT01137682 · started 2010 · scored riskier than 23% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.