CClinicalTrials.gg
Sign In
CompletedNCT03285178STRONG SCDUpdated Jul 21, 2023Results posted

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 interventional study of IW-1701 and Placebo in Sickle Cell Disease, sponsored by Cyclerion Therapeutics. Completed at 37 sites in 3 countries. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-21.

Sponsored by Cyclerion Therapeutics · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
16 Years to 70 Years
Sex
All
01

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.

02

Conditions studied

  • Sickle Cell Disease

Browse trials for

Keywords

  • Sickle Cell Disease
  • SCD
  • Olinciguat
  • IW-1701
03

Who can participate

Ages eligible
16 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient is ambulatory male or female 16 to 70 years of age at the Screening Visit.
  2. Patient has SCD, including homozygous hemoglobin S (HbSS), hemoglobin SC disease (HbSC), heterozygous hemoglobin S-beta zero (HbSβ0)-thalassemia, or heterozygous hemoglobin S-beta plus (HbSβ+)-thalassemia, documented in their medical history.
  3. If patient is on medication(s) for SCD, such as hydroxyurea (HU), are on a stable regimen.
  4. Per medical history and/or patient recall, patient has had at least 1 and no more than 10 sickle cell-related pain crises in the 12 months before the Screening Visit and none occurring in the 4 weeks before the Randomization Visit.
  5. Patient completes daily eDiary entries for at least 10 days during the last 14 days of the Run in Period as assessed at the Randomization Visit.
  6. Women of childbearing potential must have a negative pregnancy test prior to randomization and must agree to use protocol-specified contraception from the Screening Visit through 90 days after the final dose of study drug.
  7. Male patients must be surgically sterile by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) or must agree to use protocol-specified contraception and agree to refrain from sperm donation from the Screening Visit through 90 days after the final dose of study drug.

Exclusion criteria

EXCLUSION CRITERIA

  1. Patient requires a program of prescheduled, regularly administered chronic blood transfusion therapy.
  2. Patient has been hospitalized for an SCD-related complication in the 4 weeks before the Randomization Visit.
  3. Patient has taken opioid(s) >200 morphine mg equivalent/day within the 4 weeks before the Randomization Visit.
  4. Patient is taking aspirin ≥325 mg daily, P2Y12 inhibitors, any anticoagulant medication, specific inhibitors of phosphodiesterase 5 (PDE5), nonspecific inhibitors of phosphodiesterase 5 (PDE5), moderate or strong cytochrome P450 3A (CYP3A) inhibitors, any supplements for the treatment of erectile dysfunction, riociguat, or nitrates or nitric oxide donors in any form.
  5. Patient has major concurrent illness or medical condition that in the opinion of the Investigator would preclude participation in a clinical study.

NOTE: Other inclusion and exclusion criteria apply, per protocol

04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    IW-1701 (Olinciguat) 2 mg

    After a single-blind treatment with placebo once daily (QD) for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1, participants received 1 mg olinciguat QD Week 1 and 2 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3.

    Drug: IW-1701

  • Experimental
    IW-1701 (Olinciguat) 4 mg

    After a single-blind treatment with placebo QD for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1, participants received 2 mg olinciguat QD Week 1 and 4 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3.

    Drug: IW-1701

  • Experimental
    IW-1701 (Olinciguat) 6 mg

    After a single-blind treatment with placebo QD for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1, participants received 3 mg olinciguat QD Week 1 and 6 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3.

    Drug: IW-1701

  • Experimental
    IW-1701 (Olinciguat) 18 mg

    After a single-blind treatment with placebo QD for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1, participants received 6 mg olinciguat QD Days 1-7, 12 mg olinciguat QD Weeks 1-3, and 18 mg olinciguat QD Weeks 4-12 under protocol Amendment 4 and later.

    Drug: IW-1701

  • Placebo comparator
    Placebo

    After a single-blind treatment with placebo QD for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1, participants received placebo treatment QD for 12 weeks.

    Drug: Placebo

Interventions

  • DrugIW-1701

    Oral Tablet

    Also known as: Olinciguat

  • DrugPlacebo

    Oral Tablet

05

What researchers measure

Primary outcomes

  1. Double-Blind Treatment: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    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 study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. Adverse Events of special interest (AESIs) included symptomatic or Grade ≥2 hypotensive events and/or tachycardia AEs, bleeding events, pulmonary edema, and bone-related events, including fractures.

    Time frame: First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.

  2. Double-Blind Treatment: Number of TEAE Events

    An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An 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 study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. If a participant had more than 1 occurrence in the same event category, only the occurrence with closest relationship to study drug was counted.

    Time frame: First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.

  3. Double-Blind Treatment: Number of Participants With ≥1 TEAE, by Maximum Severity

    An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An 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 study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. If a participant had more than 1 occurrence in the same event category, only the most severe occurrence was counted.

    Time frame: First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.

  4. Double-Blind Treatment: Number of Participants With Study Drug-Related TEAEs

    An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An 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 study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. If a participant had more than 1 occurrence in the same event category, only the occurrence with closest relationship to study drug was counted.

    Time frame: First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.

06

Results

Posted Jul 21, 2023

Participant flow

Single-Blind Run-In Period
Participant flow — Single-Blind Run-In Period
MilestoneSingle-Blind Run-in: PlaceboDouble-Blind Treatment: Placebo 1Double-Blind Treatment: Placebo 2Double-Blind Treatment: IW-1701 (Olinciguat) 2 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 4 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 6 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 18 mg
Started88000000
Completed70000000
Not completed18000000
Withdrew: Covid-19 pandemic precautions - suspended by institutional review board (irb)3000000
Withdrew: Covid-19 pandemic precautions- suspended per local guidelines1000000
Withdrew: Protocol violation11000000
Withdrew: Withdrawal by subject1000000
Withdrew: Physician decision2000000
Double-Blind Treatment Period
Participant flow — Double-Blind Treatment Period
MilestoneSingle-Blind Run-in: PlaceboDouble-Blind Treatment: Placebo 1Double-Blind Treatment: Placebo 2Double-Blind Treatment: IW-1701 (Olinciguat) 2 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 4 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 6 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 18 mg
Started0109881124
Completed08676921
Not completed0231223
Withdrew: Randomized mistakenly during the run-in period - did not receive study drug0110000
Withdrew: Adverse event0000002
Withdrew: Lost to follow-up0100200
Withdrew: Withdrawal by subject0011021
Withdrew: Covid-190010000

Outcome measures

PrimaryDouble-Blind Treatment: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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 study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. Adverse Events of special interest (AESIs) included symptomatic or Grade ≥2 hypotensive events and/or tachycardia AEs, bleeding events, pulmonary edema, and bone-related events, including fractures.

Time frame:
First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
Reported as:
Count of participants · Participants
Double-Blind Treatment: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
ParticipantsDouble-Blind Treatment: Placebo 1Double-Blind Treatment: Placebo 2Double-Blind Treatment: IW-1701 (Olinciguat) 2 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 4 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 6 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 18 mg
Participants with >=1 TEAE6655821
Participants with >=1 Grade 3-5 TEAE222347
Participants with >=1 Study Drug-Related TEAE302047
Participants with >=1 SAE212346
Participants with >=1 TEAE Leading to Study Drug Discontinuation000002
Participants with >=1 AESI000001
PrimaryDouble-Blind Treatment: Number of TEAE Events

An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An 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 study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. If a participant had more than 1 occurrence in the same event category, only the occurrence with closest relationship to study drug was counted.

Time frame:
First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
Reported as:
Number · TEAE Events
Double-Blind Treatment: Number of TEAE Events
TEAE EventsPlacebo 1Placebo 2IW-1701 (Olinciguat) 2 mgIW-1701 (Olinciguat) 4 mgIW-1701 (Olinciguat) 6 mgIW-1701 (Olinciguat) 18 mg
Double-Blind Treatment: Number of TEAE Events2629363039101
PrimaryDouble-Blind Treatment: Number of Participants With ≥1 TEAE, by Maximum Severity

An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An 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 study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. If a participant had more than 1 occurrence in the same event category, only the most severe occurrence was counted.

Time frame:
First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
Reported as:
Count of participants · Participants
Double-Blind Treatment: Number of Participants With ≥1 TEAE, by Maximum Severity
ParticipantsPlacebo 1Placebo 2IW-1701 (Olinciguat) 2 mgIW-1701 (Olinciguat) 4 mgIW-1701 (Olinciguat) 6 mgIW-1701 (Olinciguat) 18 mg
Participants with ≥1 TEAE: Any6655821
Participants with ≥1 TEAE: Grade 1040226
Participants with ≥1 TEAE: Grade 2403028
Participants with ≥1 TEAE: Grade 3222347
Participants with ≥1 TEAE: Grade 4000000
Participants with ≥1 TEAE: Grade 5000000
PrimaryDouble-Blind Treatment: Number of Participants With Study Drug-Related TEAEs

An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An 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 study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. If a participant had more than 1 occurrence in the same event category, only the occurrence with closest relationship to study drug was counted.

Time frame:
First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
Reported as:
Count of participants · Participants
Double-Blind Treatment: Number of Participants With Study Drug-Related TEAEs
ParticipantsPlacebo 1Placebo 2IW-1701 (Olinciguat) 2 mgIW-1701 (Olinciguat) 4 mgIW-1701 (Olinciguat) 6 mgIW-1701 (Olinciguat) 18 mg
Double-Blind Treatment: Number of Participants With Study Drug-Related TEAEs302047

Adverse events

Collected over AEs during Single-blind Run-in Period were collected from first dose of Run-in placebo up to the first dose of randomized study drug, up to 17 days. AEs during the Double-Blind Period: First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Single-Blind Run-in Period: Placebo0/88 (0%)2/88 (2.3%)18/88 (20.5%)
Double-Blind Treatment Period: Placebo 10/9 (0%)2/9 (22.2%)6/9 (66.7%)
Double-Blind Treatment Period: Placebo 20/8 (0%)1/8 (12.5%)6/8 (75%)
Double-Blind Treatment Period: IW-1701 (Olinciguat) 2 mg0/8 (0%)2/8 (25%)5/8 (62.5%)
Double-Blind Treatment Period: IW-1701 (Olinciguat) 4 mg0/8 (0%)3/8 (37.5%)5/8 (62.5%)
Double-Blind Treatment Period: IW-1701 (Olinciguat) 6 mg0/11 (0%)4/11 (36.4%)6/11 (54.5%)
Double-Blind Treatment Period: IW-1701 (Olinciguat) 18 mg0/24 (0%)6/24 (25%)20/24 (83.3%)
Most frequent serious events
Most frequent serious events
EventSingle-Blind Run-in Period: PlaceboDouble-Blind Treatment Period: Placebo 1Double-Blind Treatment Period: Placebo 2Double-Blind Treatment Period: IW-1701 (Olinciguat) 2 mgDouble-Blind Treatment Period: IW-1701 (Olinciguat) 4 mgDouble-Blind Treatment Period: IW-1701 (Olinciguat) 6 mgDouble-Blind Treatment Period: IW-1701 (Olinciguat) 18 mg
SICKLE CELL ANAEMIA WITH CRISISBlood and lymphatic system disorders1/881/91/82/83/83/113/24
PNEUMONIAInfections and infestations0/881/90/80/81/80/110/24
ABDOMINAL PAINGastrointestinal disorders0/881/90/80/80/80/110/24
ARTHRALGIAMusculoskeletal and connective tissue disorders0/880/90/80/80/81/110/24
NON-CARDIAC CHEST PAINGeneral disorders0/880/90/80/80/81/110/24
ACUTE CHEST SYNDROMERespiratory, thoracic and mediastinal disorders0/880/90/80/80/80/111/24
APLASTIC ANAEMIABlood and lymphatic system disorders0/880/90/80/80/80/111/24
IMPAIRED GASTRIC EMPTYINGGastrointestinal disorders0/880/90/80/80/80/111/24
MENORRHAGIAReproductive system and breast disorders0/880/90/80/80/80/111/24
INTERVERTEBRAL DISC PROTRUSIONMusculoskeletal and connective tissue disorders1/880/90/80/80/80/110/24
Most frequent other events
Showing 10 of 103
Most frequent other events
EventSingle-Blind Run-in Period: PlaceboDouble-Blind Treatment Period: Placebo 1Double-Blind Treatment Period: Placebo 2Double-Blind Treatment Period: IW-1701 (Olinciguat) 2 mgDouble-Blind Treatment Period: IW-1701 (Olinciguat) 4 mgDouble-Blind Treatment Period: IW-1701 (Olinciguat) 6 mgDouble-Blind Treatment Period: IW-1701 (Olinciguat) 18 mg
SICKLE CELL ANAEMIA WITH CRISISBlood and lymphatic system disorders3/881/91/83/81/80/113/24
BACK PAINMusculoskeletal and connective tissue disorders4/880/92/82/80/80/111/24
ARTHRALGIAMusculoskeletal and connective tissue disorders1/880/91/82/81/81/112/24
PAIN IN EXTREMITYMusculoskeletal and connective tissue disorders1/881/91/82/80/80/115/24
ABDOMINAL PAINGastrointestinal disorders1/880/92/80/80/80/110/24
NAUSEAGastrointestinal disorders1/882/92/80/81/82/112/24
HEADACHENervous system disorders3/881/92/80/81/82/116/24
DIZZINESSNervous system disorders0/880/90/82/80/80/110/24
ANAEMIABlood and lymphatic system disorders0/880/92/80/80/80/112/24
OROPHARYNGEAL PAINRespiratory, thoracic and mediastinal disorders0/880/90/82/81/80/110/24

Baseline characteristics

Safety Population: Randomized participants who received at least 1 dose of study drug

Age, Continuous
Age, Continuous(years)Double-Blind Treatment: Placebo 1Double-Blind Treatment: Placebo 2Double-Blind Treatment: IW-1701 (Olinciguat) 2 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 4 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 6 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 18 mgTotal
Mean30.3 ± 9.4331.5 ± 9.2926.3 ± 10.5134.5 ± 11.3834.4 ± 13.3432.7 ± 12.6332.0 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)Double-Blind Treatment: Placebo 1Double-Blind Treatment: Placebo 2Double-Blind Treatment: IW-1701 (Olinciguat) 2 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 4 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 6 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 18 mgTotal
Female755761444
Male233151024
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Double-Blind Treatment: Placebo 1Double-Blind Treatment: Placebo 2Double-Blind Treatment: IW-1701 (Olinciguat) 2 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 4 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 6 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 18 mgTotal
Black or African American8488101553
White04000913
Not Reported1000102
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Double-Blind Treatment: Placebo 1Double-Blind Treatment: Placebo 2Double-Blind Treatment: IW-1701 (Olinciguat) 2 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 4 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 6 mgDouble-Blind Treatment: IW-1701 (Olinciguat) 18 mgTotal
Hispanic or Latino1000102
Not Hispanic or Latino7768102260
Not Reported0110013
Unknown1010013
07

Study locations

37 sites
  • Children's Hospital of Orange County
    Orange, California 92868, United States
  • MedStar Health Research Institute, MedStar Washington Hospital Center
    Washington, District of Columbia 20010, United States
  • Howard University Center for Sickle Cell Disease
    Washington, District of Columbia 20060, United States
  • Innovative Medical Research of South Florida, Inc.
    Aventura, Florida 33180, United States
  • Century Clinical Research, Inc.
    Fort Lauderdale, Florida 32117, United States
  • Foundation for Sickle Cell Disease Research
    Hollywood, Florida 33021, United States
  • Omega Research Maitland, LLC
    Orlando, Florida 32810, United States
  • Grady Memorial Hospital
    Atlanta, Georgia 30303, United States
  • Atlanta Center for Medical Research
    Atlanta, Georgia 30331, United States
  • University of Illinois at Chicago
    Chicago, Illinois 60612, United States
  • Healthcare Research Network II, LLC
    Flossmoor, Illinois 60422, United States
  • Clinical Trials of SWLA, LLC
    Lake Charles, Louisiana 70601, United States
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • Johns Hopkins School of Medicine Children's Center
    Baltimore, Maryland 21205, United States
  • Boston Children's Hospital
    Boston, Massachusetts 02115, United States
  • Children's Hospital of Michigan-Detroit
    Detroit, Michigan 33021, United States
  • Healthcare Research Network
    Hazelwood, Missouri 63042, United States
  • Hackensack University Medical Center, Pediatric Hematology and Oncology
    Hackensack, New Jersey 07601, United States
  • Jacobi Medical Center
    Bronx, New York 10461, United States
  • New York Medical College
    Valhalla, New York 10595, United States
  • East Carolina University - Leo W. Jenkins Cancer Center
    Greenville, North Carolina 27834, United States
  • East Carolina University Brody School of Medicine, Department of Pediatrics, Division of Pediatric Hematology
    Greenville, North Carolina 27834, United States
  • Lynn Institute of Tulsa
    Tulsa, Oklahoma 74105, United States
  • The Clinical Trial Center LLC
    Jenkintown, Pennsylvania 19046, United States
  • University of Pittsburgh Medical Center Hillman Cancer Center
    Pittsburgh, Pennsylvania 15232, United States
  • Accurate Clinical Research
    Baytown, Texas 77521, United States
  • "UT Health Clinical Research Unit Center for Clinical and Translational Sciences
    Houston, Texas 77030, United States
  • Mays Cancer Center UT Health San Antonio
    San Antonio, Texas 78229, United States
  • Virginia Commonwealth University - Clinical Research Unit
    Richmond, Virginia 23298, United States
  • Blood Center of Wisconsin (BCW)
    Wauwatosa, Wisconsin 53226, United States
  • Hammoud Hospital University Medical Center
    Sidon, Lebanon
  • Nini Hospital
    Tripoli, Lebanon
  • Royal London Hospital
    London, E1 2ES, United Kingdom
  • Whittington Hospital
    London, N19 5NF, United Kingdom
  • Guys and St Thomas NHS Foundation Trust - Evelina London Childrens Hospital
    London, SE1 7EH, United Kingdom
  • Guy's Hospital
    London, SE1 9RT, United Kingdom
  • Hammersmith Hospital
    London, W12 0NN, United Kingdom
08

References and documents

Study documents

  • Study protocol · Jul 24, 2019
  • Statistical analysis plan · May 22, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03285178
Lead sponsor
Cyclerion Therapeutics
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Dec 22, 2017
Primary completion
Jul 22, 2020
Completion
Jul 22, 2020
Results posted
Jul 21, 2023
Last update
Jul 21, 2023

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 completed, as verified in Jul 2023. 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.

Other studies in this condition

Anemia, Sickle Cell→

Other studies from this sponsor

Cyclerion Therapeutics

Start the discussion