Study of PIPE-791 for Subjects With Chronic Osteoarthritis Pain or Chronic Low Back Pain

NCT06810245 | Completed Phase 1 FDA Drug

• 1 other identifier: CTX-791-103
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 5

Brief Summary

The primary goal of this clinical trial is to learn if PIPE-791 is safe and well-tolerated in adults with chronic osteoarthritis pain (COAP) or chronic low back pain (CLBP). The study will also explore whether PIPE-791 lowers pain in people with COAP or CLBP. Subjects will:

• Complete a washout period to stop their current pain medications.
• Take a daily dose of PIPE-791 or placebo for 4 weeks, then reverse treatment assignment for another 4 weeks.
• Record pain levels and track dosing in a daily e-diary.
• Visit the clinic for checkups and lab tests throughout the study.
• Complete phone assessments during the treatment periods.

Conditions

Chronic Osteoarthritis Pain; Chronic Low Back Pain

Keywords

chronic pain; pain; low back pain; osteoarthritis pain; osteoarthritis; pain management; neuropathic pain; CLBP; COAP; OA

Outcome Measures

Primary Outcomes (1)

• Number of subjects with Treatment-emergent adverse events (TEAEs)

  The number of subjects with TEAEs will be summarized in each treatment arm and compared within each treatment period.

  For Treatment Period 1, from Baseline (Day 1) to End of Treatment Period 1 (TP1; Day 29), for Treatment Period 2, from Baseline of Treatment Period 2 (TP2; Day 29) to End of TP2 (Day 57).

Study Arms (2)

Active followed by Placebo

EXPERIMENTAL

Drug: PIPE-791; Drug: Placebo

Placebo followed by Active

EXPERIMENTAL

Drug: PIPE-791; Drug: Placebo

Interventions

PIPE-791 DRUG

PIPE-791 tablet, taken once daily for 4 weeks

Active followed by Placebo; Placebo followed by Active

Placebo DRUG

Placebo tablet, taken once daily for 4 weeks

Active followed by Placebo; Placebo followed by Active

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Contineum Therapeutics: lead

Study Sites (5)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

Altoona Center of Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Chronic Pain; Pain; Low Back Pain; Osteoarthritis; Agnosia; Neuralgia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 5, 2025
• Study Start: February 4, 2025
• Primary Completion: January 20, 2026
• Study Completion: January 20, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)