NCT04895696Active, not recruitingPhase 2
A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 248 (actual)
- First submitted
- 19 May 2021
- Start date
- 11 Oct 2021
- Primary completion date
- 12 Jun 2026
- Lead sponsor
- Beeline Medicines Corporation
- Diseases
- Lupus (SLE)
- NCT number
- NCT04895696
- EU CT number
- 2023-504320-25-00
- EudraCT number
- 2019-004021-25
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 248
- From 11 Oct 2021 to the primary completion date, 12 Jun 2026
- 145 sites in 19 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE
- Antiphospholipid Syndrome
- Other protocol-defined inclusion/exclusion criteria apply
Other
- Active severe lupus nephritis (LN) as assessed by the investigator
- Active or unstable neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI
Who the study is looking for
- Diagnosed ≥ 12 weeks before the screening visit and qualify as having SLE according to the SLE International Collaborating Clinics (SLICC) Classification Criteria at the screening visit
- Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody ≥ 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody.
- Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score ≥ 6 points and clinical Hybrid SLEDAI score ≥ 4 points with joint involvement and/or rash
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (145)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0074 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Local Institution - 0207 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Local Institution - 0128 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Local Institution - 0040 Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Local Institution - 0025 Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Local Institution - 0130 Coordinator of this site? Confirm its status | Quilmes | Argentina | Unknown status |
| Local Institution - 0195 Coordinator of this site? Confirm its status | San Fernando | Argentina | Unknown status |
| Local Institution - 0041 Coordinator of this site? Confirm its status | San Juan | Argentina | Unknown status |
| Local Institution - 0027 Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Local Institution - 0063 Coordinator of this site? Confirm its status | Botany | Australia | Unknown status |
| Local Institution - 0062 Coordinator of this site? Confirm its status | Camberwell | Australia | Unknown status |
| Local Institution - 0064 Coordinator of this site? Confirm its status | Ivanhoe | Australia | Unknown status |
| Local Institution - 0066 Coordinator of this site? Confirm its status | Maroochydore | Australia | Unknown status |
| Local Institution - 0072 Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Local Institution - 0065 Coordinator of this site? Confirm its status | Woodville | Australia | Unknown status |
| Local Institution - 0093 Coordinator of this site? Confirm its status | Cuiabá | Brazil | Unknown status |
| Local Institution - 0010 Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Local Institution - 0008 Coordinator of this site? Confirm its status | Juiz de Fora | Brazil | Unknown status |
| Local Institution - 0007 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Local Institution - 0006 Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Local Institution - 0031 Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Local Institution - 0014 Coordinator of this site? Confirm its status | São Bernardo do Campo | Brazil | Unknown status |
| Local Institution - 0045 Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
| Local Institution - 0009 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Local Institution - 0127 Coordinator of this site? Confirm its status | Osorno | Chile | Unknown status |
| Local Institution - 0075 Coordinator of this site? Confirm its status | Providencia | Chile | Unknown status |
| Local Institution - 0043 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0073 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0143 Coordinator of this site? Confirm its status | Valdivia | Chile | Unknown status |
| Local Institution - 0180 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0177 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0174 Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Local Institution - 0179 Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| Local Institution - 0178 Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Local Institution - 0183 Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| Local Institution - 0188 Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Local Institution - 0176 Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Local Institution - 0184 Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Local Institution - 0193 Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | Barranquilla | Colombia | Unknown status |
| Local Institution - 0004 Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Local Institution - 0076 Coordinator of this site? Confirm its status | Cali | Colombia | Unknown status |
| Local Institution - 0005 Coordinator of this site? Confirm its status | Chía | Colombia | Unknown status |
| Local Institution - 0190 Coordinator of this site? Confirm its status | Medellín | Colombia | Unknown status |
| Local Institution - 0003 Coordinator of this site? Confirm its status | Zipaquirá | Colombia | Unknown status |
| Charite Research Organisation GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Active, not recruiting |
| Complejo Hospitalario Universitario Juan Canalejo Coordinator of this site? Confirm its status | A Coruna | Spain | Active, not recruiting |
| Vall D'hebron Institut De Recerca Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| Hospital Universitario Virgen De Valme Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Centre Hospitalier Regional Et Universitaire De Brest Coordinator of this site? Confirm its status | Brest Cedex 2 | France | Completed |
| Hopital Huriez Coordinator of this site? Confirm its status | Lille Cedex | France | Completed |
| Hopital Europeen Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Completed |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Completed |
| Local Institution - 0110 Coordinator of this site? Confirm its status | Bradford | United Kingdom | Unknown status |
| Local Institution - 0111 Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Local Institution - 0125 Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Connolly Hospital Coordinator of this site? Confirm its status | Dublin 15 | Ireland | Completed |
| Merlin Park University Hospital Coordinator of this site? Confirm its status | Galway | Ireland | Completed |
| Our Ladys Hospital Manorhamilton Coordinator of this site? Confirm its status | Sligo | Ireland | Completed |
| Local Institution - 0226 Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Local Institution - 0210 Coordinator of this site? Confirm its status | Bengaluru | India | Unknown status |
| Local Institution - 0214 Coordinator of this site? Confirm its status | Gurugram | India | Unknown status |
| Local Institution - 0208 Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Local Institution - 0209 Coordinator of this site? Confirm its status | Secunderabad | India | Unknown status |
| Local Institution - 0138 Coordinator of this site? Confirm its status | Aichi | Japan | Unknown status |
| Local Institution - 0117 Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Unknown status |
| Local Institution - 0115 Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Local Institution - 0114 Coordinator of this site? Confirm its status | Eiheiji-cho,Yoshida-gun | Japan | Unknown status |
| Local Institution - 0218 Coordinator of this site? Confirm its status | Fuchū | Japan | Unknown status |
| Local Institution - 0162 Coordinator of this site? Confirm its status | Fukushima | Japan | Unknown status |
| Local Institution - 0104 Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Local Institution - 0095 Coordinator of this site? Confirm its status | Kitakyushu | Japan | Unknown status |
| Local Institution - 0150 Coordinator of this site? Confirm its status | Meguro-ku | Japan | Unknown status |
| Local Institution - 0096 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Local Institution - 0099 Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Local Institution - 0098 Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Local Institution - 0105 Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Local Institution - 0113 Coordinator of this site? Confirm its status | tabashi City | Japan | Unknown status |
| Local Institution - 0116 Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Local Institution - 0097 Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Local Institution - 0021 Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Local Institution - 0017 Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Local Institution - 0020 Coordinator of this site? Confirm its status | León | Mexico | Unknown status |
| Local Institution - 0061 Coordinator of this site? Confirm its status | Mérida | Mexico | Unknown status |
| Local Institution - 0018 Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Local Institution - 0060 Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Local Institution - 0158 Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Local Institution - 0071 Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Local Institution - 0022 Coordinator of this site? Confirm its status | Zapopan | Mexico | Unknown status |
| Medyczne Centrum Hetmańska Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Centrum Medyczne Reuma Park Coordinator of this site? Confirm its status | Warszawa | Poland | Completed |
| MICS Centrum Medyczne Warszawa Coordinator of this site? Confirm its status | Warszawa | Poland | Completed |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Local Institution - 0037 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Hightech Medical Services S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Saint Maria Hospital Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| SC MedAudio-Optica SRL Coordinator of this site? Confirm its status | Râmnicu Vâlcea | Romania | Active, not recruiting |
| Centrul de Kinetoterapie si Masaj Banat SRL Coordinator of this site? Confirm its status | Timisoara | Romania | Active, not recruiting |
| Local Institution - 0080 Coordinator of this site? Confirm its status | Kaohsiung Niao Sung Dist | Taiwan | Unknown status |
| Local Institution - 0081 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Local Institution - 0078 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Local Institution - 0079 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0077 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0152 Coordinator of this site? Confirm its status | Allen | United States | Unknown status |
| Local Institution - 0197 Coordinator of this site? Confirm its status | Allen | United States | Unknown status |
| Local Institution - 0136 Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| Local Institution - 0160 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Local Institution - 0171 Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| Local Institution - 0223 Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Local Institution - 0100 Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Local Institution - 0203 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Local Institution - 0103 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Local Institution - 0121 Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Local Institution - 0151 Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Local Institution - 0070 Coordinator of this site? Confirm its status | Eagan | United States | Unknown status |
| Local Institution - 0187 Coordinator of this site? Confirm its status | Hopkinsville | United States | Unknown status |
| Local Institution - 0123 Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| Local Institution - 0167 Coordinator of this site? Confirm its status | Kissimmee | United States | Unknown status |
| Local Institution - 0170 Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Local Institution - 0159 Coordinator of this site? Confirm its status | La Palma | United States | Unknown status |
| Local Institution - 0091 Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Local Institution - 0140 Coordinator of this site? Confirm its status | Manhasset | United States | Unknown status |
| Local Institution - 0029 Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| Local Institution - 0042 Coordinator of this site? Confirm its status | Middleburg Heights | United States | Unknown status |
| Local Institution - 0122 Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Local Institution - 0146 Coordinator of this site? Confirm its status | Orland Park | United States | Unknown status |
| Local Institution - 0173 Coordinator of this site? Confirm its status | Ormond Beach | United States | Unknown status |
| Local Institution - 0154 Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| Local Institution - 0163 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Local Institution - 0172 Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Local Institution - 0137 Coordinator of this site? Confirm its status | South Miami | United States | Unknown status |
| Local Institution - 0124 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Local Institution - 0165 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Local Institution - 0205 Coordinator of this site? Confirm its status | Suwanee | United States | Unknown status |
| Local Institution - 0155 Coordinator of this site? Confirm its status | Tamarac | United States | Unknown status |
| Local Institution - 0132 Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Local Institution - 0219 Coordinator of this site? Confirm its status | West Long Branch | United States | Unknown status |
| Local Institution - 0134 Coordinator of this site? Confirm its status | Wheaton | United States | Unknown status |
| Local Institution - 0164 Coordinator of this site? Confirm its status | Woodland Hills | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.