Evaluating PIPE-791 for chronic osteoarthritis and low back pain

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Crossover Multicenter Study to Explore the Safety and Efficacy of Oral PIPE-791 As Treatment in Subjects with Chronic Osteoarthritis Pain (COAP) or Chronic Low Back Pain (CLBP)

This study is testing a new medication called PIPE-791 to see if it can help adults with chronic osteoarthritis or low back pain feel better.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Contineum Therapeutics (Industry-sponsored)
• Locations: 5 sites (Phoenix, Arizona and 4 other locations)
• Trial ID: NCT06810245 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and tolerability of PIPE-791 in adults suffering from chronic osteoarthritis pain or chronic low back pain. Participants will undergo a washout period to stop their current pain medications before being randomized to receive either PIPE-791 or a placebo for four weeks, followed by a crossover to the alternate treatment for another four weeks. Throughout the study, subjects will track their pain levels and medication usage in an electronic diary and attend regular clinic visits for safety assessments and lab tests. The total duration of participation is approximately 16 weeks, including screening, treatment, and follow-up.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a diagnosis of chronic osteoarthritis or chronic low back pain for at least six months.

Not a fit: Patients with other chronic pain conditions or those unable to discontinue their current pain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from chronic osteoarthritis pain and chronic low back pain.

How similar studies have performed: While this approach is novel, similar studies evaluating new treatments for chronic pain have shown promise in the past.

Eligibility criteria

Key Inclusion Criteria

* Male or female 18 to 70 years of age, inclusive, at the first Screening visit.
* Only one of the following chronic pain diagnoses at least 6 months prior to Screening:
* Osteoarthritis of the knee OR low back pain (with or without painful lumbosacral radiculopathy)
* Plain radiographs of the knee or lumbar spine consistent with diagnosis within 9 months prior to or during Screening.
* History of related daily pain for at least 6 months prior to Screening.
* Have a body mass index \<40 (inclusive) at Screening.
* Willing to maintain a consistent regimen of any ongoing (stable format and frequency for the duration of study participation) non-pharmacologic pain-relieving therapies.
* Willing to discontinue medications taken for chronic pain conditions and usage of transcutaneous electrical nerve stimulation for the duration of the study.
* Male or female subjects with reproductive potential agree to comply with a highly effective contraceptive method as per protocol through 90 days after last study drug administration.
* Subjects taking systemic hormone-replacement therapy must be on a stable dose and regimen for at least 1 month prior to Screening.
* General good medical health with no clinically significant or relevant abnormalities except those attributed to the underlying chronic pain condition, including medical history, physical exam, vital signs, ECG, and laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigator.
* Ability to use an eDiary to record daily pain scores.

Key Exclusion Criteria

* History of refractory chronic pain after multiple failed treatments as determined by the Investigator (e.g., no response to all of the following: surgery and/or nerve blocks, a regimen of at least two non-opioid pharmacotherapies, and physical rehabilitation, and weak opioids).
* Concurrent diagnosis of fibromyalgia or evidence of chronic widespread pain, or other pain that may interfere with the assessment of CLBP or COAP.
* Demonstrated noncompliance recording daily Numerical Rating Scale (NRS) scores during Screening.
* Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest, e.g., an ablation procedure.
* Received capsaicin treatment (e.g., Qutenza) within the past 3 months prior to screening.
* Have surgery planned during the study for any reason, related or not, to the disease state under evaluation.
* Are non-ambulatory (use of assistive devices is allowed).
* History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis.
* Diagnosed with OA during childhood or adolescence, including post-traumatic OA or OA due to genetic (e.g., hip dysplasia) or congenital (e.g., metabolic disorders) conditions.
* History of or clinical signs or symptoms of active joint infection, crystal disease of the knee, or a history of arthritis due to crystals (e.g., gout, pseudo gout).
* History of prior lumbar or thoracic spine surgery (e.g., discectomies, laminectomies, foraminotomies, or fusion).

Where this trial is running

Phoenix, Arizona and 4 other locations

• Arizona Research Center — Phoenix, Arizona, United States (Recruiting)
• Drug Studies America — Marietta, Georgia, United States (Recruiting)
• Drug Trials America — Hartsdale, New York, United States (Recruiting)
• Altoona Center of Clinical Research — Duncansville, Pennsylvania, United States (Recruiting)
• JBR Clinical Research — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Jayne Holzinger

Conditions Chronic Osteoarthritis Pain; Chronic Low Back Pain; chronic pain; pain; low back pain; osteoarthritis pain; osteoarthritis; pain management