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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (β) Thalassemia

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Erythrocyte Transfusion, Beta-Thalassemia
    Erythrocyte Transfusion, Beta-Thalassemia
  • Phase Phase 3
    Phase 3
INTERVENTION

Drug: Luspatercept, Other: Placebo

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Luspatercept, Other: Placebo

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Children's Hospital of Los Angeles, Los Angeles, California, United States

Brief Summary

This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) plus Best supportive care (BSC) versus placebo plus BSC in adults who require regular red blood cell transfusion due to (β)-thalassemia. The study is divided into the following periods: - Historical Period, - Screening/Run-in Period, - Double-blind Treatment Period (48 weeks), - Double-blind Long-term Treatment Period, (at the investigator's discretion an additional 48 weeks), - Open-Label Phase post unblinding and upon Data Monitoring Committee positive recommendation - Post-treatment Follow-up Period

A Safety Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib With Concomitant Luspatercept for Subjects With Anemia

  • Status Recruiting
    Recruiting
  • Condition Primary Myelofibrosis, Post-Polycythemia Vera, Myelofibrosis
    Primary Myelofibrosis, Post-Polycythemia Vera, Myelofibrosis
  • Phase Phase 3
    Phase 3
INTERVENTION

Drug: FEDRATINIB, Drug: Luspatercept

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: FEDRATINIB, Drug: Luspatercept

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

University of Colorado Cancer Center, Aurora, Colorado, United States

Brief Summary

This is Single-Arm, Open-Label Efficacy and Safety Trial of Fedratinib in Subjects with DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High- Risk Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (post-PV MF), or Post-Essential Thrombocythemia Myelofibrosis (post-ET MF) and Previously Treated with Ruxolitinib including a Sub-study with concomitant Luspatercept for subjects with anemia. The primary objective of the main study is to evaluate the percentage of subjects with at least a 35% reduction in spleen size and one of the secondary objectives is to evaluate the safety of fedratinib. The primary objective of the sub-study is to evaluate the safety and tolerability of Luspatercept when administered concomitantly with Fedratinib.

A Safety and Efficacy Study to Evaluate Luspatercept in Subjects With Myeloproliferative Neoplasm-associated Myelofibrosis Who Have Anemia With and Without Red Blood Cell-transfusion Dependence

  • Status Recruiting
    Recruiting
  • Condition Anemia, Primary Myelofibrosis
    Anemia, Primary Myelofibrosis
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Mayo Clinic - Arizona, Phoenix, Arizona, United States

Brief Summary

This is a Phase 2, multicenter, open-label study to evaluate the efficacy and safety of luspatercept in subjects with MPN-associated myelofibrosis and anemia with and without RBC-transfusion dependence. The study is divided into a Screening Period, a Treatment Period (consisting of a Primary Phase, a Day 169 Disease Response Assessment, and an Extension Phase), followed by a Posttreatment Follow-up Period.

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Pulmonary Arterial Hypertension
    Pulmonary Arterial Hypertension
  • Phase Phase 2
    Phase 2
INTERVENTION

Biological: Sotatercept

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Biological: Sotatercept

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

The University of Arizona, Tucson, Arizona, United States

Brief Summary

This study evaluates the effect of sotatercept (ACE-011) in adults with Pulmonary Arterial Hypertension. Each eligible participant will receive standard of care (SOC) plus sotatercept (ACE-011) for a 24 week treatment period, followed by an 18 month Extension Period and an 8 week follow up period.

A Study to Evaluate Long-term Safety in Subjects Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials

  • Status Recruiting
    Recruiting
  • Condition Beta-thalassemia, Myelodysplastic Syndromes (MDS), Myeloprolifera...
    Beta-thalassemia, Myelodysplastic Syndromes (MDS), Myeloprolifera...
  • Phase Phase 3
    Phase 3
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Hopital Henri Mondor, Creteil, France

Brief Summary

A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following subjects: - Subjects receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit in the opinion of the investigator from continuing treatment with luspatercept. - Placebo arm subjects from parent protocol (at the time of unblinding or in follow-up) crossing over to luspatercept treatment (provided subjects have met all requirements for entering the rollover study as per the parent protocol). - Subjects in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met (unless they meet requirements as per parent protocol to cross-over to luspatercept treatment). The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Subjects will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase. - Transition Phase (Screening): up to 21 days prior to enrollment - Treatment Phase: For subjects in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. For placebo arm subjects from parent protocol (at the time of unblinding or in follow-up) crossing over to luspatercept treatment (provided subjects have met all requirements for entering the rollover study as per the parent protocol) will start at a luspatercept dose of 1.0 mg/kg every 3 weeks (Q3W). This does not apply to subjects that are in long-term follow-up from the parent protocol. - Follow-up Phase: - 42 Day Safety Follow-up Phase: subjects will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting. - Long-term Post-treatment Follow-up (LTPTFU) Phase: All subjects who are continuing in the LTPTFU Phase, will continue to be followed for 5 years from Dose 1 of the parent protocol, or 3 years of post-treatment from last dose of the parent protocol, whichever occurs later. Subjects will be followed every 6 months until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Subjects will also be monitored for progression to AML or any malignancies/pre- malignancies. New anticancer or disease related therapies should be collected at the same time schedule. Subjects transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study. The rollover study will be terminated, and relevant subjects will discontinue from the study when all subjects fulfill 5 years from Dose 1 of the parent protocol, or 3 years of post-treatment from last dose of the parent protocol, whichever occurs later. The shift to commercial drug is an alternative way to stop the study.

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Pulmonary Arterial Hypertension
    Pulmonary Arterial Hypertension
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: Placebo, Drug: Sotatercept

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Placebo, Drug: Sotatercept

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Pulmonary Associates, PA, Phoenix, Arizona, United States

Brief Summary

Study A011-09 is designed to assesses the efficacy and safety of sotatercept (ACE-011) relative to placebo in adults with pulmonary arterial hypertension (PAH). Eligible participants will receive study treatment for 6 months in the Placebo-Controlled Treatment Period, and then will be eligible to enroll into an 18- month Extension Period during which all participants will receive sotatercept. All treated patients will be also undergo follow-up period after last study drug treatment.

Luspatercept and Lenalidomide (L2) in Lower-risk, Non-del(5q) MDS Patients

  • Status Not yet recruiting
    Not yet recruiting
  • Condition Myelodysplastic Syndromes
    Myelodysplastic Syndromes
  • Phase Phase 1 Phase 2
    Phase 1 Phase 2
INTERVENTION

Drug: Lenalidomide, Drug: Luspatercept

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Lenalidomide, Drug: Luspatercept

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Brief Summary

The purpose of this study is to evaluate if the combination of drugs, Lenalidomide and Luspatercept, will help improve the treatment of anemia in people with lower-risk MDS. Anemia is a condition in which the blood does not have enough healthy red blood cells. Red blood cells are made in an area of the bone called the bone marrow. Anemia is a common side effect in people who have MDS because this cancer disrupts the production of red blood cells in the bone marrow. Sometimes anemia can be treated successfully with a therapy known as an erythropoiesis-stimulating agent (ESA). The ESA medication tries to help the bone marrow make more red blood cells. However, some people do not respond to this treatment and have limited options. This research study is to improve anemia treatment options for people with MDS who have not responded, or are unlikely to respond to ESAs.

A Study to Determine the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AG-348 in Adult Participants With Non-transfusion-dependent Thalassemia

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Thalassemia
    Thalassemia
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: AG-348

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: AG-348

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

UCSF Benioff Children's Hospital Oakland, Oakland, California, United States

Brief Summary

Study AG348-C-010 is a multicenter study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of treatment with AG-348 in adult participants with non-transfusion-dependent thalassemia (NTDT). This study will include a core period (up to 24 weeks) followed by an extension period (up to 10 years) for eligible participants. Approximately 17 participants with NTDT will be enrolled. The initial dose of AG-348 will be 50 milligrams (mg) twice daily (BID) with one potential dose-level increase to 100 mg BID, at the Week 6 visit based on the participant's safety and hemoglobin (Hb) concentrations.

An Efficacy and Safety Study of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in Japanese Subjects Who Are Not Requiring Red Blood Cell Transfusion

  • Status Recruiting
    Recruiting
  • Condition Myelodysplastic Syndromes
    Myelodysplastic Syndromes
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages: 20 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Chiba Aoba Municipal Hospital, Chiba, Japan

Brief Summary

The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a Phase 2, multicenter, single-arm study to evaluate the efficacy, safety and Pharmacokinetics (PK) of luspatercept (ACE-536) for the treatment of anemia due to International prognostic scoring system-Revised (IPSS-R) very low, low or intermediate risk Myelodysplastic syndromes (MDS)in Japanese subjects who are not requiring Red blood cell (RBC) transfusion. The study is divided into the Screening Period, a Treatment Period and a Post-Treatment Follow up Period.

MPN-RC 118 AVID200 in Myelofibrosis

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Primary Myelofibrosis, Post-essential Thrombocythemia Myelofibros...
    Primary Myelofibrosis, Post-essential Thrombocythemia Myelofibros...
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: AVID200

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: AVID200

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Icahn School of Medicine at Mount Sinai, New York, New York, United States

Brief Summary

Increased levels of TGF-β1 were detected in serum, plasma and BM and positively correlated with both grade of BMF and extent of leukemic cell infiltration in the marrow. TGF-β likely plays a dual role in promoting myelofibrosis and myeloproliferation, both of which are the bone marrow morphologic hallmark of MF. AVID200 is a drug that targets TGF-β1 and TGF-β3. The study team hypothesizes that inhibiting the TGF-β signaling pathway in MF will decrease the fibrogenic stimuli leading to myelofibrosis and concomitantly interrupt myeloproliferation and restore normal hematopoiesis. This is a first in human, open-label, multicenter, Phase I/Ib trial of AVID200. Patients must have intermediate-2 or higher primary myelofibrosis (PMF), post-essential thrombocythemia or polycythemia-vera related MF (Post ET/PV MF). This study will enroll up to 24 patients. AVID200 is delivered by IV infusion on day 1 of each 3 week cycle.