Novel phytopharmaceutical alpha linolenic acid 18n:3 nanoformulation for symptomatic treatment of acute and chronic pain in homozygous HbSS sickle cell disease patients

Innovative, standardized linseed oil extract based alpha linolenic acid 18n:3 formulation targeted at treating acute and chronic painful complications in sickle cell crisis

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202506834698530

Enrollment

Registered

2025-06-20

Start date

2025-09-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haematological Disorders

Interventions

ALADRE SOULAGE 1

Placebo SOULAGE 1

ALADRE SOULAGE 2

Reference Treatment SOULAGE 2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Please note that these are key inclusion criteria for all participants. Additional cohort-specific inclusion criteria may apply. SOULAGE 1 Study Part: 1. Participant (healthy volunteer) is able to understand and provide informed consent prior to the conduct of any protocol-specific screeing procedures. 2. Participant is able to complete all study assessments and procedures. 3. Participant is able to swallow tablets and emulsion as contained in sachets. 4. Participant has a body weight at inclusion visit of at least 40 kg. 5. Participant has undergone a normal medical examination during screening visit consisting of clinical examination, blood level analyses, medical history and electrocardiogramme (12 derivation ECG). SOULAGE 2 Study Part A: Confirmed Sickle Cell Disease With Blood Transfusions 1. Participant (sickle cell disease patient with blood transfusions) is able to understand and provide informed consent prior to the conduct of any protocol-specific screeing procedures. 2. Participant is able to complete all study assessments and procedures. 3. Participant is able to swallow tablets and emulsion as contained in sachets. 4. Participant has a body weight at inclusion visit of at least 40 kg. 5. Participant has undergone medical examination during screening visit consisting of clinical examination, blood level analyses, medical history and electrocardiogramme (12 derivation ECG). 6. At least one blood transfusion/month during 24 months for secondary prevention of cerebrovascular SOULAGE 2 Study Part B: Confirmed Sickle Cell Disease Without Blood Transfusions 1. Participant (sickle cell disease patient without blood transfusions) is able to understand and provide informed consent prior to the conduct of any protocol-specific screeing procedures. 2. Participant is able to complete all study assessments and procedures. 3. Participant is able to swallow tablets and emulsion as contained in sachets. 4. and 5. as in Part A above

Exclusion criteria

Exclusion criteria: Please note that these are key exclusion criteria for all participants. Additional cohort-specific exclusion criteria may apply. The following exclusion citeria apply to all cohorts of SOULAGE 1 and SOULAGE 2 Study Parts A and B: 1. Breast-feeding or pregnancy in female participants 2. Hepatic dysfunction or insufficiency as defined by: - AST and/or ALT values exceeding at least 4 times the upper limits of normal, respectively - free, non conjugated bilirubin exceeding at least 3 times the upper limit of normal - liver cirrhosis as confirmed by anamnesis 3. HIV positivity 4. Acute hepatitis B or C infection 5. Chronic renal insufficiency grade 3, 4 or 5 as defined by GFR < 60 ml/min 6. Malignant tumor as confirmed by prior chemotherapy or radiotherapy during the 24 months preceding the intake of the first dose of the study product 7. Unstable cardiac and/or pulmonary disease as evidenced by anamnesis during the 6 months prior to the participant providing written informed consent and comprising the follwoing disease conditions: - unstable angina, myocardial infarction or invasive coronary treatment - heart failure hospital treatment - cardiac arrhythmia - symptomatic arterial pulmonary hypertension 8. Participant havin received another investigational drug drug within 30 days or 5 half-lives, whichever is longer, prior to taking the first dose of the study product 9. Participant having undergone major surgery within 6 months prior to taking the first study product

Design outcomes

Primary

Measure	Time frame
SOULAGE 1, SOULAGE 2 Study Part A and SOULAGE 2 Study Part B - Incidence, frequency and severity of adverse events and serious adverse events - Vital signs including blood pressure, herat and respiratory rates, oral temperature, body weight, bedside 12-lead ECG monitoring heart rate, PR and RR intervals, respectively, QRS duration, QT and QTcF intervals. Physical medical examination. Concomitant medication usage. Clinical chemistry including blood chemistry, urinalysis. Hematology analysis including coagulation parameters. Immunology analysis including inflammatory marker proteins, i.e., hsCRP and others. Plasma pharmacokinetic parameter analysis for study drug including but not limited to Cmax, Tmax, AUC 0-24, AUC 0-last, t1/2, CL/F, Vd/F, dose proportionality following single and multiple dose administration. In addition, as regards SOULAGE Study Parts A and B - increase of hemoglobinemia Hb of at least 1 g/100 ml vs. baseline value 12 weeks following study drug compared active control reference treatment.	—

Measure

Time frame

SOULAGE 1, SOULAGE 2 Study Part A and SOULAGE 2 Study Part B - Incidence, frequency and severity of adverse events and serious adverse events - Vital signs including blood pressure, herat and respiratory rates, oral temperature, body weight, bedside 12-lead ECG monitoring heart rate, PR and RR intervals, respectively, QRS duration, QT and QTcF intervals. Physical medical examination. Concomitant medication usage. Clinical chemistry including blood chemistry, urinalysis. Hematology analysis including coagulation parameters. Immunology analysis including inflammatory marker proteins, i.e., hsCRP and others. Plasma pharmacokinetic parameter analysis for study drug including but not limited to Cmax, Tmax, AUC 0-24, AUC 0-last, t1/2, CL/F, Vd/F, dose proportionality following single and multiple dose administration. In addition, as regards SOULAGE Study Parts A and B - increase of hemoglobinemia Hb of at least 1 g/100 ml vs. baseline value 12 weeks following study drug compared active control reference treatment.

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Secondary

Measure	Time frame
SOULAGE 2 Study Parts A and B - Change from baseline in percentage of sickle cells and HbF hemoglobinemia, F reticulocytes, F cells and in pharmacokinetic parameters, e.g., Cmax, Tmax, AUC 0-24 and AUC 0 - last - Percentage ncrease of Hb hemoglobinemia of at least 1,0 g/100 ml vs. baseline 12, 24 and 48 weeks following the intake of the last dose of study drug - Serum ferritins changes vs. baseline 12, 24 and 48 weeks follwoing last intake of study drug - Change from baseline in plasma thrombocyte concentration and vWF, P-selectin, VCAM-1, ICAM-1 and MCP-1 12 weeks following last intake of study drug - Change from baseline in hsCRP serum concentration at 12 weeks and changes in activation marker levels of pro-oxydant inflammatory mediators measured in peripheral blood mononuclear cells PBMCs following intake of the last study dose, respectively. In addition to the above, SOULAGE Study Part B determines the percentage of participants, i.e., patients, with sickle cell disease receiving blood transfusions in whom a reduction of at least 20 percent vs. active control treatment, e.g., consisting of standard reference treatment with hydroxyurea and folic acid and analgesics, of blood transfusions of erythrocyte concentrates has been determined at 12 weeks following intake of the last dose of study drug - Reduction of the number of blood transfusion erythrocyte concentrates 12, 24 and 48 weeks, respectively following the last intake of the study drug.	—

Measure

Time frame

SOULAGE 2 Study Parts A and B - Change from baseline in percentage of sickle cells and HbF hemoglobinemia, F reticulocytes, F cells and in pharmacokinetic parameters, e.g., Cmax, Tmax, AUC 0-24 and AUC 0 - last - Percentage ncrease of Hb hemoglobinemia of at least 1,0 g/100 ml vs. baseline 12, 24 and 48 weeks following the intake of the last dose of study drug - Serum ferritins changes vs. baseline 12, 24 and 48 weeks follwoing last intake of study drug - Change from baseline in plasma thrombocyte concentration and vWF, P-selectin, VCAM-1, ICAM-1 and MCP-1 12 weeks following last intake of study drug - Change from baseline in hsCRP serum concentration at 12 weeks and changes in activation marker levels of pro-oxydant inflammatory mediators measured in peripheral blood mononuclear cells PBMCs following intake of the last study dose, respectively. In addition to the above, SOULAGE Study Part B determines the percentage of participants, i.e., patients, with sickle cell disease receiving blood transfusions in whom a reduction of at least 20 percent vs. active control treatment, e.g., consisting of standard reference treatment with hydroxyurea and folic acid and analgesics, of blood transfusions of erythrocyte concentrates has been determined at 12 weeks following intake of the last dose of study drug - Reduction of the number of blood transfusion erythrocyte concentrates 12, 24 and 48 weeks, respectively following the last intake of the study drug.

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Countries

Senegal

Contacts

Public ContactSaliou DIOP

Associated Principal Investigator

saliou.diop@ucad.edu.sn+221338698661

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026