Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the Knee

Last updated: November 18, 2025
Sponsor: Grünenthal GmbH
Overall Status: Completed

Phase

3

Condition

Osteoarthritis

Treatment

RTX-GRT7039

Clinical Study ID

NCT05377489
KF7039-03
2024-515709-24-00
2021-005046-15
U1111-1268-7230
  • Ages > 18
  • All Genders

Study Summary

An open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of RTX-GRT7039 in patients who have pain associated with osteoarthritis of the knee despite standard of care.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The participant has given written informed consent to participate.

  • The participant is 18 years of age or older at the Screening Visit.

  • The participant has a diagnosis of osteoarthritis of the knee based on AmericanCollege of Rheumatology criteria and functional capacity class of I to III.

  • There is a documented history indicating that participant has insufficient painrelief with previous Standard of Care.

Exclusion

Exclusion Criteria:

  • The participant has past joint replacement surgery of the index knee.

  • The participant has a history of significant trauma or surgery (e.g., open orarthroscopic) to the index knee within 12 months of Screening.

  • The participant has periarticular pain at the index knee from any cause other thanosteoarthritis, including referred pain, bursitis, tendonitis.

  • The participant has clinical hip osteoarthritis on the side of the index knee.

  • The participant has a history of osteonecrosis, subchondral insufficiency fracture,atrophic osteoarthritis, rapidly progressing osteoarthritis (RPOA) Type I or TypeII,pathologic fracture, primary or metastatic tumor, or joint infection in the indexknee.

  • The participant has significant malalignment of anatomical axis (medial angle formedby the femur and tibia) of the target knee (varus >10°, valgus >10°) by radiographas assessed by independent Central Readers at Screening Visit.

  • The participant has other conditions that could affect trial endpoint assessments ofthe index knee.

  • The participant has current clinically significant disease(s) or condition(s) thatmay affect safety assessments, or any other reason which may preclude theparticipant's participation for the full duration of the trial.

  • The participant has a history of hypersensitivity to resiniferatoxin (RTX) or anysimilar component (capsaicin, chili peppers).

  • The participant is currently participating or was participating in anotherinvestigational drug trial within 3 months prior to the Screening Visit.

  • The participant is an employee of the investigator or trial site, with directinvolvement in the proposed trial or other trials under the direction of thatinvestigator or trial site or is a family member of the employees or theinvestigator.

The non-index knee is not eligible for treatment in the trial, if any of the knee-related exclusion criteria applies to the non-index knee.

Study Design

Total Participants: 714
Treatment Group(s): 1
Primary Treatment: RTX-GRT7039
Phase: 3
Study Start date:
September 15, 2022
Estimated Completion Date:
May 15, 2025

Study Description

This trial comprises a total observation period of up to 78 weeks.

Connect with a study center

  • MHAT Kaspela EOOD

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Medical Centre Artmed

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • UMHAT Eurohospital Plovdiv OOD

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • UMHAT Pulmed

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital For Active Treatment Pulmed OOD

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • MHAT Kaspela EOOD

    Plovdiv 728193, 4002
    Bulgaria

    Site Not Available

  • Medical Centre Artmed

    Plovdiv 728193, 4002
    Bulgaria

    Site Not Available

  • UMHAT Eurohospital Plovdiv OOD

    Plovdiv 728193, 4000
    Bulgaria

    Site Not Available

  • UMHAT Pulmed

    Plovdiv 728193, 4002
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital For Active Treatment Pulmed OOD

    Plovdiv 728193, 4002
    Bulgaria

    Site Not Available

  • MHAT St Iv. Rilski

    Sofia, 1612
    Bulgaria

    Site Not Available

  • Medical Centre N. I. Pirogov EOOD

    Sofia, 1000
    Bulgaria

    Site Not Available

  • Synexus Medical Center Sofia

    Sofia, 1784
    Bulgaria

    Site Not Available

  • UMBAL Sveti Ivan Rilski EAD

    Sofia, 1612
    Bulgaria

    Site Not Available

  • MHAT St Iv. Rilski

    Sofia 727011, 1612
    Bulgaria

    Site Not Available

  • Medical Centre N. I. Pirogov EOOD

    Sofia 727011, 1000
    Bulgaria

    Site Not Available

  • Synexus Medical Center Sofia

    Sofia 727011, 1784
    Bulgaria

    Site Not Available

  • UMBAL Sveti Ivan Rilski EAD

    Sofia 727011, 1612
    Bulgaria

    Site Not Available

  • Multi-Profile District Hospital for Active Treatment Dr. Stefan Cherkezov

    Veliko Tarnovo 725993, 5000
    Bulgaria

    Site Not Available

  • Multi-Profile District Hospital for Active Treatment Dr. Stefan Cherkezov

    Weliko Tarnowo, 5000
    Bulgaria

    Site Not Available

  • Centro de Investigación Médico Asistencial S.A.S - CIMEDICAL S.A.S

    Barranquilla, Atlántico 080020
    Colombia

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    Fukuoka-shi, Fukuoka 8140180
    Japan

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    Kitakyushu-city, Fukuoka 802-8517
    Japan

    Site Not Available

  • Fukuoka University Hospital

    Fukuoka 1863967, Fukuoka 1863958 8140180
    Japan

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  • Medical Corporation Kouhoukai Takagi Hospital

    Okawa-shi, Fukuoka 1863958 831-0016
    Japan

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    Hakodate, Hokkaido 040-8585
    Japan

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    Hakodate 2130188, Hokkaido 2130037 040-8585
    Japan

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    Yokohama-shi, Kanagawa 221-0821
    Japan

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    Yokohama 1848354, Kanagawa 1860291 221-0821
    Japan

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  • Otakibashi Orthopedic Clinic

    Shinjuku-ku, Tokyo 1850144 169-0073
    Japan

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    Saitama, 350-8550
    Japan

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    Saitama 6940394, 350-8550
    Japan

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    Wroclaw, Dolnoslaskie 50-556
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    Bloemfontein, Free State 9301
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    Bloemfontein 1018725, Free State 967573 9301
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    Welkom 940909, Free State 967573 9460
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    Benoni, Gauteng
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    Halfway House, Gauteng 1685
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    Johannesburg, Gauteng 1500
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    Pretoria, Gauteng 0002
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    Roodepoort, Gauteng 1724
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    Sandton, Gauteng 2196
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    Benoni 1020098, Gauteng 1085594
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    Halfway House 998210, Gauteng 1085594 1685
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  • University of Pretoria

    Pretoria 964137, Gauteng 1085594 0002
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    Roodepoort 936374, Gauteng 1085594 1724
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    Sandton 957654, Gauteng 1085594 2196
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    Kempton Park, Johannesburg 1619
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    Kempton Park 991415, Johannesburg 1619
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    Durban, Kwa Zulu Natal 4091
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    Durban, Kwa Zulu Natal 4091
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    Durban, Kwa-Zulu Natal 4092
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    Umkomaas, Kwa-Zulu Natal 4170
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    Durban 1007311, KwaZulu-Natal 972062 4091
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    Durban 1007311, KwaZulu-Natal 972062 4092
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    Durban 1007311, KwaZulu-Natal 972062 4001
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    eMkhomazi 946128, KwaZulu-Natal 972062 4170
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    Kraaifontein, Western Cape 7570
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    Kraaifontein 3365083, Western Cape 1085599 7570
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    Cape Town, 7405
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    Shipley, Yorkshire BD18 3SA
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    Leeds, LS7 4SA
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    Leeds 2644688, LS7 4SA
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    Glendale, Arizona 85306
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    Phoenix, Arizona 85018
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    West Palm Beach, Florida 33409
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    Troy, Michigan 48085
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    Raleigh 4487042, North Carolina 4482348 27704
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    State College, Pennsylvania 16801
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  • Wasatch Clinical Research

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Wasatch Clinical Research

    Salt Lake City 5780993, Utah 5549030 84107
    United States

    Site Not Available

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