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NCT03285178 · ClinicalTrials.gov registry record · Phase 2

A Study of the Effect of IW-1701 (Olinciguat), a Stimulator of Soluble Guanylate Cyclase (sGC), on Patients With Sickle Cell Disease (SCD)

A Phase 2 study, sponsored by Cyclerion Therapeutics.

Completed
Registry status
Phase 2
Development phase
88
Enrollment target

NCT03285178: Completed Phase 2 study, sponsored by Cyclerion Therapeutics.

NCT03285178 is a Phase 2 study that has completed, run by Cyclerion Therapeutics. The registered enrollment target is 88 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03285178, a Phase 2 study, has completed, sponsored by Cyclerion Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
88 participants
Enrollment target

Study Summary

The primary objective of the 1701-202 STRONG SCD study is to evaluate the safety and tolerability of different dose levels of IW-1701 compared with placebo when administered daily for approximately 12 weeks to patients with stable SCD. Exploratory objectives include evaluation of pharmacokinetic (PK) as well as evaluation of the effect of IW-1701 on symptoms of SCD, health-related quality of life, and biomarkers of pharmacodynamic (PD) activity.

Primary Outcome

An adverse event (AE) is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. A serious AE (SAE) is defined as any AE occurring at any dose that results in any of the following: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. A TEAE is an event that occurs after initiation of randomized

Interventions

  • DRUG Placebo
  • DRUG IW-1701

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2017-12-22
Est. Completion 2020-07-22
Phase Phase 2
Cyclerion Therapeutics

11 total trials

What the finished NCT03285178 record still lists

NCT03285178 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03285178 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03285178 about?

NCT03285178 is a clinical study titled "A Study of the Effect of IW-1701 (Olinciguat), a Stimulator of Soluble Guanylate Cyclase (sGC), on Patients With Sickle Cell Disease (SCD)". The primary objective of the 1701-202 STRONG SCD study is to evaluate the safety and tolerability of different dose levels of IW-1701 compared with placebo when administered daily for approximately 12 weeks to patients with stable SCD. Exploratory objectives include evaluation of pharmacokinetic (PK...

What is the current status of trial NCT03285178?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2017-12-22. Estimated completion is 2020-07-22.

What interventions are being tested in trial NCT03285178?

The interventions under investigation include: Placebo (DRUG), IW-1701 (DRUG).

Who is sponsoring clinical trial NCT03285178?

This trial is sponsored by Cyclerion Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03285178's enrollment target sits among peer trials

88 803rd of 2000 higher than 1,191 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03285178, the US trial registry maintained by the National Library of Medicine. NCT03285178 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.