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

Phase 1

Recruiting

• Conditions: Chronic Osteoarthritis Pain; Chronic Low Back Pain
• Interventions: Drug: PIPE-791; Drug: Placebo

• Registration Number: NCT06810245
• Lead Sponsor: Contineum Therapeutics

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.

Detailed Description

This is a double-blind, randomized, placebo-controlled, 2-period crossover study designed to evaluate the safety and tolerability of PIPE-791 in approximately 20 adults with COAP and 20 adults with CLBP (with or without painful lumbosacral radiculopathy). Subjects will be randomized to receive either PIPE-791 or placebo daily for 4 weeks, followed by a crossover to the alternate treatment assignment for an additional 4 weeks.

A washout period of all chronic pain medications is required prior to randomization. Rescue medications, including acetaminophen and naproxen, will be permitted during the study.

Subjects will complete regular clinic visits for safety assessments, laboratory testing, and physical evaluations. Daily pain scores and dosing information will be reported by subjects using an electronic diary (e-diary).

All subjects who complete dosing will have a post-treatment safety follow-up/end of study (EOS) phone visit approximately 28 days after the last dose of study drug. Subjects who prematurely discontinue dosing and all assessments from the study will have an early termination (ET) visit as soon as possible on or after their last dose of study drug.

The total duration of participation, including screening, treatment, and follow-up, is approximately 16 weeks.

Study Timeline

• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-31
• Status Verified: 2025-02
• Study Start: 2025-02-04
• Study First Posted: 2025-02-05
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-12-15
• Study Completion: 2026-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active followed by Placebo	PIPE-791	-
Active followed by Placebo	Placebo	-
Placebo followed by Active	PIPE-791	-
Placebo followed by Active	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with Treatment-emergent adverse events (TEAEs)	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).	The number of subjects with TEAEs will be summarized in each treatment arm and compared within each treatment period.

Trial Locations

Locations (5)

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Drug Studies America; 🇺🇸 Marietta, Georgia, United States

Drug Trials America; 🇺🇸 Hartsdale, New York, United States

Altoona Center of Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

JBR Clinical Research; 🇺🇸 Salt Lake City, Utah, United States