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 (formerly part of Ironwood Pharmaceuticals, Inc.) · Phase 2, Interventional, and Treatment
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.
1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.
This study's enrollment of 88 is above the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Cyclerion Therapeutics is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
First submitted before Cyclerion Therapeutics left Ironwood Pharmaceuticals, Inc..
Counted across the registry records on this site, refreshed daily.
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.
EXCLUSION CRITERIA
NOTE: Other inclusion and exclusion criteria apply, per protocol
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
Oral Tablet
Also known as: Olinciguat
Oral Tablet
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.
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.
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.
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.
| Milestone | Single-Blind Run-in: Placebo | Double-Blind Treatment: Placebo 1 | Double-Blind Treatment: Placebo 2 | Double-Blind Treatment: IW-1701 (Olinciguat) 2 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 4 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 6 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 18 mg |
|---|---|---|---|---|---|---|---|
| Started | 88 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 70 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 18 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Covid-19 pandemic precautions - suspended by institutional review board (irb) | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Covid-19 pandemic precautions- suspended per local guidelines | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 11 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Single-Blind Run-in: Placebo | Double-Blind Treatment: Placebo 1 | Double-Blind Treatment: Placebo 2 | Double-Blind Treatment: IW-1701 (Olinciguat) 2 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 4 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 6 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 18 mg |
|---|---|---|---|---|---|---|---|
| Started | 0 | 10 | 9 | 8 | 8 | 11 | 24 |
| Completed | 0 | 8 | 6 | 7 | 6 | 9 | 21 |
| Not completed | 0 | 2 | 3 | 1 | 2 | 2 | 3 |
| Withdrew: Randomized mistakenly during the run-in period - did not receive study drug | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 | 2 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 1 | 0 | 2 | 1 |
| Withdrew: Covid-19 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
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.
| Participants | Double-Blind Treatment: Placebo 1 | Double-Blind Treatment: Placebo 2 | Double-Blind Treatment: IW-1701 (Olinciguat) 2 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 4 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 6 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 18 mg |
|---|---|---|---|---|---|---|
| Participants with >=1 TEAE | 6 | 6 | 5 | 5 | 8 | 21 |
| Participants with >=1 Grade 3-5 TEAE | 2 | 2 | 2 | 3 | 4 | 7 |
| Participants with >=1 Study Drug-Related TEAE | 3 | 0 | 2 | 0 | 4 | 7 |
| Participants with >=1 SAE | 2 | 1 | 2 | 3 | 4 | 6 |
| Participants with >=1 TEAE Leading to Study Drug Discontinuation | 0 | 0 | 0 | 0 | 0 | 2 |
| Participants with >=1 AESI | 0 | 0 | 0 | 0 | 0 | 1 |
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.
| TEAE Events | Placebo 1 | Placebo 2 | IW-1701 (Olinciguat) 2 mg | IW-1701 (Olinciguat) 4 mg | IW-1701 (Olinciguat) 6 mg | IW-1701 (Olinciguat) 18 mg |
|---|---|---|---|---|---|---|
| Double-Blind Treatment: Number of TEAE Events | 26 | 29 | 36 | 30 | 39 | 101 |
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.
| Participants | Placebo 1 | Placebo 2 | IW-1701 (Olinciguat) 2 mg | IW-1701 (Olinciguat) 4 mg | IW-1701 (Olinciguat) 6 mg | IW-1701 (Olinciguat) 18 mg |
|---|---|---|---|---|---|---|
| Participants with ≥1 TEAE: Any | 6 | 6 | 5 | 5 | 8 | 21 |
| Participants with ≥1 TEAE: Grade 1 | 0 | 4 | 0 | 2 | 2 | 6 |
| Participants with ≥1 TEAE: Grade 2 | 4 | 0 | 3 | 0 | 2 | 8 |
| Participants with ≥1 TEAE: Grade 3 | 2 | 2 | 2 | 3 | 4 | 7 |
| Participants with ≥1 TEAE: Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Participants with ≥1 TEAE: Grade 5 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Placebo 1 | Placebo 2 | IW-1701 (Olinciguat) 2 mg | IW-1701 (Olinciguat) 4 mg | IW-1701 (Olinciguat) 6 mg | IW-1701 (Olinciguat) 18 mg |
|---|---|---|---|---|---|---|
| Double-Blind Treatment: Number of Participants With Study Drug-Related TEAEs | 3 | 0 | 2 | 0 | 4 | 7 |
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single-Blind Run-in Period: Placebo | 0/88 (0%) | 2/88 (2.3%) | 18/88 (20.5%) |
| Double-Blind Treatment Period: Placebo 1 | 0/9 (0%) | 2/9 (22.2%) | 6/9 (66.7%) |
| Double-Blind Treatment Period: Placebo 2 | 0/8 (0%) | 1/8 (12.5%) | 6/8 (75%) |
| Double-Blind Treatment Period: IW-1701 (Olinciguat) 2 mg | 0/8 (0%) | 2/8 (25%) | 5/8 (62.5%) |
| Double-Blind Treatment Period: IW-1701 (Olinciguat) 4 mg | 0/8 (0%) | 3/8 (37.5%) | 5/8 (62.5%) |
| Double-Blind Treatment Period: IW-1701 (Olinciguat) 6 mg | 0/11 (0%) | 4/11 (36.4%) | 6/11 (54.5%) |
| Double-Blind Treatment Period: IW-1701 (Olinciguat) 18 mg | 0/24 (0%) | 6/24 (25%) | 20/24 (83.3%) |
| Event | Single-Blind Run-in Period: Placebo | Double-Blind Treatment Period: Placebo 1 | Double-Blind Treatment Period: Placebo 2 | Double-Blind Treatment Period: IW-1701 (Olinciguat) 2 mg | Double-Blind Treatment Period: IW-1701 (Olinciguat) 4 mg | Double-Blind Treatment Period: IW-1701 (Olinciguat) 6 mg | Double-Blind Treatment Period: IW-1701 (Olinciguat) 18 mg |
|---|---|---|---|---|---|---|---|
| SICKLE CELL ANAEMIA WITH CRISISBlood and lymphatic system disorders | 1/88 | 1/9 | 1/8 | 2/8 | 3/8 | 3/11 | 3/24 |
| PNEUMONIAInfections and infestations | 0/88 | 1/9 | 0/8 | 0/8 | 1/8 | 0/11 | 0/24 |
| ABDOMINAL PAINGastrointestinal disorders | 0/88 | 1/9 | 0/8 | 0/8 | 0/8 | 0/11 | 0/24 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 0/88 | 0/9 | 0/8 | 0/8 | 0/8 | 1/11 | 0/24 |
| NON-CARDIAC CHEST PAINGeneral disorders | 0/88 | 0/9 | 0/8 | 0/8 | 0/8 | 1/11 | 0/24 |
| ACUTE CHEST SYNDROMERespiratory, thoracic and mediastinal disorders | 0/88 | 0/9 | 0/8 | 0/8 | 0/8 | 0/11 | 1/24 |
| APLASTIC ANAEMIABlood and lymphatic system disorders | 0/88 | 0/9 | 0/8 | 0/8 | 0/8 | 0/11 | 1/24 |
| IMPAIRED GASTRIC EMPTYINGGastrointestinal disorders | 0/88 | 0/9 | 0/8 | 0/8 | 0/8 | 0/11 | 1/24 |
| MENORRHAGIAReproductive system and breast disorders | 0/88 | 0/9 | 0/8 | 0/8 | 0/8 | 0/11 | 1/24 |
| INTERVERTEBRAL DISC PROTRUSIONMusculoskeletal and connective tissue disorders | 1/88 | 0/9 | 0/8 | 0/8 | 0/8 | 0/11 | 0/24 |
| Event | Single-Blind Run-in Period: Placebo | Double-Blind Treatment Period: Placebo 1 | Double-Blind Treatment Period: Placebo 2 | Double-Blind Treatment Period: IW-1701 (Olinciguat) 2 mg | Double-Blind Treatment Period: IW-1701 (Olinciguat) 4 mg | Double-Blind Treatment Period: IW-1701 (Olinciguat) 6 mg | Double-Blind Treatment Period: IW-1701 (Olinciguat) 18 mg |
|---|---|---|---|---|---|---|---|
| SICKLE CELL ANAEMIA WITH CRISISBlood and lymphatic system disorders | 3/88 | 1/9 | 1/8 | 3/8 | 1/8 | 0/11 | 3/24 |
| BACK PAINMusculoskeletal and connective tissue disorders | 4/88 | 0/9 | 2/8 | 2/8 | 0/8 | 0/11 | 1/24 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 1/88 | 0/9 | 1/8 | 2/8 | 1/8 | 1/11 | 2/24 |
| PAIN IN EXTREMITYMusculoskeletal and connective tissue disorders | 1/88 | 1/9 | 1/8 | 2/8 | 0/8 | 0/11 | 5/24 |
| ABDOMINAL PAINGastrointestinal disorders | 1/88 | 0/9 | 2/8 | 0/8 | 0/8 | 0/11 | 0/24 |
| NAUSEAGastrointestinal disorders | 1/88 | 2/9 | 2/8 | 0/8 | 1/8 | 2/11 | 2/24 |
| HEADACHENervous system disorders | 3/88 | 1/9 | 2/8 | 0/8 | 1/8 | 2/11 | 6/24 |
| DIZZINESSNervous system disorders | 0/88 | 0/9 | 0/8 | 2/8 | 0/8 | 0/11 | 0/24 |
| ANAEMIABlood and lymphatic system disorders | 0/88 | 0/9 | 2/8 | 0/8 | 0/8 | 0/11 | 2/24 |
| OROPHARYNGEAL PAINRespiratory, thoracic and mediastinal disorders | 0/88 | 0/9 | 0/8 | 2/8 | 1/8 | 0/11 | 0/24 |
Safety Population: Randomized participants who received at least 1 dose of study drug
| Age, Continuous(years) | Double-Blind Treatment: Placebo 1 | Double-Blind Treatment: Placebo 2 | Double-Blind Treatment: IW-1701 (Olinciguat) 2 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 4 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 6 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 18 mg | Total |
|---|---|---|---|---|---|---|---|
| Mean | 30.3 ± 9.43 | 31.5 ± 9.29 | 26.3 ± 10.51 | 34.5 ± 11.38 | 34.4 ± 13.34 | 32.7 ± 12.63 | 32.0 ± 11.5 |
| Sex: Female, Male(Participants) | Double-Blind Treatment: Placebo 1 | Double-Blind Treatment: Placebo 2 | Double-Blind Treatment: IW-1701 (Olinciguat) 2 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 4 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 6 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 18 mg | Total |
|---|---|---|---|---|---|---|---|
| Female | 7 | 5 | 5 | 7 | 6 | 14 | 44 |
| Male | 2 | 3 | 3 | 1 | 5 | 10 | 24 |
| Race/Ethnicity, Customized(Participants) | Double-Blind Treatment: Placebo 1 | Double-Blind Treatment: Placebo 2 | Double-Blind Treatment: IW-1701 (Olinciguat) 2 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 4 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 6 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 18 mg | Total |
|---|---|---|---|---|---|---|---|
| Black or African American | 8 | 4 | 8 | 8 | 10 | 15 | 53 |
| White | 0 | 4 | 0 | 0 | 0 | 9 | 13 |
| Not Reported | 1 | 0 | 0 | 0 | 1 | 0 | 2 |
| Race/Ethnicity, Customized(Participants) | Double-Blind Treatment: Placebo 1 | Double-Blind Treatment: Placebo 2 | Double-Blind Treatment: IW-1701 (Olinciguat) 2 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 4 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 6 mg | Double-Blind Treatment: IW-1701 (Olinciguat) 18 mg | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 0 | 0 | 1 | 0 | 2 |
| Not Hispanic or Latino | 7 | 7 | 6 | 8 | 10 | 22 | 60 |
| Not Reported | 0 | 1 | 1 | 0 | 0 | 1 | 3 |
| Unknown | 1 | 0 | 1 | 0 | 0 | 1 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Jul 2020, 31 months.
Results were first posted in Jul 2023, 2 years 11 months after primary completion. A results delay was requested in Jul 2021.
Of 34 industry-sponsored phase 2 interventional studies under Anemia, Sickle Cell, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 41. This study's 31 months is above that.
Counting every sponsor, half of 92 studies reached it within 46 months; a quarter within 24 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Olinciguat