Clinical Trials

California Institute of Regenerative Medicine (CIRM)

A Phase 1 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate (LLP2A-Ale) in Adult Men and Women with Osteopenia Secondary to Glucocorticoids

UC Davis researchers are looking for patients with Osteopenia..

The purpose of this research study is to evaluate the safety and tolerability of intravenous LLP2A-Ale.

 Eligibility Criteria:

  1. Have Osteopenia
  2. 20-75 years of age
  3. Currently taking prednisone or another Glucocorticoid
  4. Not taking any of the following prohibited medications: bisphosphonate (oral or IV), methotrexate (up to 25 mg/week is allowed), and/or immunosuppressive drugs including rituximab, ofatumumab, ocrelizumab, or alemtuzumab
  5. Able to travel to and attend all study visits

Treatment Protocol:

Subject will be assigned to either the single ascending dose (SAD) group or the multiple ascending dose (MAD) group, and subsequently randomized into one of two treatment groups to receive the active LLP2A-Ale or the placebo.

If selected to participate in the study, subjects will receive a modest compensation for time and travel.

Length of Study: For subjects in the SAD group, the study will be up to 5 months. For subjects in the MAD group, it will be up to 7 months.

To learn about how to participate in a clinical trial, please contact us at:

UC Davis Center for Musculoskeletal Health
4625 2nd Ave., Suite 2000
Sacramento CA 95817

Telephone: 916-734-3011
Fax: 916-734-0901
Facebook: Center for Musculoskeletal Health UC Davis Medical Center
Email: CMHClinicalTrials@ucdavis.edu

 

 

 

AbbVie M14-171

A Phase 2a, Multicenter, Randomize, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-981 to Placebo in Subjects with Erosive Hand Osteoarthritis

The purpose of this study was to evaluate the effectiveness of the drug ABT-981 in decreasing pain and inflammation in patients with erosive hand OA.

ABT-981 is a new type of antibody that blocks two different proteins, IL-1α and IL-1β, which play a major role in the development and progression of Osteoarthritis (OA). ABT-981 has been studied in healthy volunteers, as well as in subjects with OA of the hand.

AbbVie M13-741

A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients with Knee Osteoarthritis

The purpose of this study was to assess the effectiveness of the drug ABT-981 in decreasing pain and inflammation in patients with OA of the knee.

ABT-981 is a new type of antibody that blocks two different proteins, IL-1α and IL-1β, which play a major role in the development and progression of Osteoarthritis (OA). ABT-981 has been studied in healthy volunteers, as well as in subjects with OA of the knee.

Myoscience

A Multi-Center, Prospective, Double-Blind, Randomized Controlled Study to Evaluate the Effectiveness and Safety of the iovera‚ó¶ Device for the Temporary Relief of Pain Associated with Knee Osteoarthritis

The purpose of this study was to evaluate the effectiveness of a cold therapy device for the temporary reduction of pain associated with knee OA. The cryotherapy targets nerve tissue, providing pain relief for up to 180 days.

Amgen 162

A Phase 3 Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

The purpose of this study was to find out if a drug called denosumab is safe and effective in people who have osteoporosis or are at risk of developing osteoporosis as a result of taking glucocorticoids. The primary objective of this trial is to evaluate the effectiveness and safety of an FDA approved drug, denosumab, compared to another FDA approved drug, risedronate.

Denosumab is a fully human monoclonal antibody designed to target a protein that acts as the primary signal for bone removal and overwhelms the body’s natural defenses against bone destruction, whereas risedronate is a bisphosphonate that strengthens bone by inhibiting bone removal by osteoclast.

Orthotrophix 100

A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects with Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees

The purpose of the study was to learn more about the drug TPX-100, a synthetic peptide derived from human protein believed to stimulate precursor cells to form hyaline cartilage.  TPX-100 represents a first-in-class and first-in-indication, disease-modifying agent administered via injection to the knee.

TPX-100 has been shown to stimulate tissue-appropriate regeneration of dentin (a calcified tissue of the body), bone, and cartilage. Successful clinical development of TPX-100 can be expected to significantly reduce the disability associated with knee OA and create a treatment option to be considered before, or instead of, surgery.

Amgen 785

A Phase 3 Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

The purpose of the study was to learn more about the drug Romosozumab in women with postmenopausal osteoporosis.  This study will see if Romosozumab prevents fractures of the bone and whether it causes any side effects.

Romosozumab is a monoclonal antibody delivered via injection that is designed to increase bone formation by inhibiting a protein associated with bone loss.

Teva 45070

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (4% and 8% w/w Ointment) in Patients with Primary Osteoarthritis Affecting a Single Knee

The purpose of the study was to learn more about the effectiveness of the drug TV-45070 in reducing knee pain in subjects with Osteoarthritis (OA) of the knee. TV45070 is an ointment belonging to the drug class known as sodium channel blockers which interferes with the transmission of pain impulses in the nerves.

Xoma

A Phase 2 Proof-of-concept Study of Gevokizumab in Active Inflammatory, Erosive Osteoarthritis of the Hand

The primary objective of this trial was to find out more about a clinical trial drug called Gevokizumab.

Gevokizumab is a monoclonal antibody meant to limit the action of specific proteins in body that release and cause inflammation.

The purpose of this study was to determine what side effects the drug may cause, and whether the drug is useful to treat and help relieve the signs and symptoms of Erosive Osteo-Arthritis of the Hand.

Knee Osteoarthritis Tanezumab

The primary objective of this trial was to evaluate the effectiveness and safety of an investigational new drug called Tanezumab and whether it helps relieve the signs and symptoms of knee osteoarthritis.  Tanezumab is an antibody.  An antibody is a type of protein that is produced by the immune system to help protect the body against foreign compounds.  Tanezumab acts against another protein, called human nerve growth factor (NGF).  NGF is a natural compound that’s made by the body and is involved in causing a person to feel pain.  It is thought that the binding of tanezumab to NGF can block NGF activity, reducing the subject’s pain.

https://www.ucdmc.ucdavis.edu/publish/news/newsroom/4365

Pfizer A4091058

A Phase 3 Randomized, Double-Blind, Active-Controlled, Multicenter Study of the Long-Term Safety and Efficacy of Subcutaneous Administration of Tanezumab in Subjects with Osteoarthritis of the Hip or Knee

The purpose of this research study was to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti-inflammatory drugs (NSAIDs) in subjects with OA of the hips or knees.

Samumed SM04690

A Phase 2, 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

The purpose of this research study was to evaluate the safety and tolerability of SM04690, and to determine the effective dose(s) of SM04690 for the treatment of knee OA.

Bisphosphonate Drug Holiday Study

A multi-center observational study using biochemical markers of bone turnover to monitor the effects of a bisphosphonate drug holiday

The purpose of this study was to use blood tests of biochemical markers of bone turnover (proteins that are released into the blood during bone formation or bone breakdown) to establish when patients who are on a bisphosphonate drug holiday may begin to lose bone mass again.

AMG 20110186

A Randomized Withdrawal Double-Blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects with Rheumatoid Arthritis

The purpose of this research study was to evaluate the efficacy of etanercept monotherapy compared to methotrexate monotherapy on maintenance of remission in subjects with rheumatoid arthritis (RA) who were on etanercept plus methotrexate combination therapy.

Regeneron R475-OA-1688

A Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo, and NSAID-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients with Pain Due to Osteoarthritis of the Knee of Hip

The purpose of this research study was to evaluate the efficacy of Fasinumab compared to placebo, when administered for up to 24 weeks in patients with OA of the knee of hip.